Cost-effectiveness of a second opinion program on spine surgeries: an economic analysis.

BACKGROUND: In this study we proposed a new strategy to measure cost-effectiveness of second opinion program on spine surgery, using as measure of effectiveness the minimal important change (MIC) in the quality of life reported by patients, including the satisfaction questionnaire regarding the treatment and direct medical costs. METHODS: Retrospective analysis of patients with prior indication for spine surgery included in a second opinion program during May 2011 to May 2019. Treatment costs and outcomes were compared considering each patients' recommended treatment before and after the second opinion. Costs were measured under the perspective of the hospital, including hospital stay, surgical room, physician and staff fees and other costs related to hospitalization when surgery was performed and physiotherapy or injection costs when a conservative treatment was recommended. Reoperation costs were also included. For comparison analysis, we used data based on our clinical practice, using data from patients who underwent the same type of surgical procedure as recommended by the first referral. The measure of effectiveness was the percentage of patients who achieved the MIC in quality of life measured by the EQ-5D-3 L 2 years after starting treatment. An incremental cost-effectiveness ratio (ICER) was calculated. RESULTS: Based upon the assessment of 1,088 patients that completed the entire second opinion process, conservative management was recommended for 662 (60.8%) patients; 49 (4.5%) were recommended to injection and 377 (34.7%) to surgery. Complex spine surgery, as arthrodesis, was recommended by second opinion in only 3.7% of cases. The program resulted in financial savings of -$6,705 per patient associated with appropriate treatment indication, with an incremental effectiveness of 0.077 patients achieving MIC when compared to the first referral, resulting in an ICER of $-87,066 per additional patient achieving the MIC, ranging between $-273,016 and $-41,832. CONCLUSION: After 2 years of treatment, the second opinion program demonstrated the potential for cost-offsets associated with improved quality of life.

Interventions for treating fractures of the patella in adults.

BACKGROUND: Fractures of the patella (kneecap) account for around 1% of all human fractures. The treatment of these fractures can be surgical or conservative (such as immobilisation with a cast or brace). There are many different surgical and conservative interventions for treating fractures of the patella in adults. This is an update of a Cochrane Review first published in 2015. OBJECTIVES: To assess the effects (benefits and harms) of interventions (surgical and conservative) for treating fractures of the patella in adults. SEARCH METHODS: We searched CENTRAL (2020, Issue 1), MEDLINE, Embase, LILACS, trial registers and references lists of articles to January 2020. SELECTION CRITERIA: We included randomised controlled trials (RCTs) or quasi-RCTs that evaluated any surgical or conservative intervention for treating adults with fractures of the patella. The primary outcomes were patient-rated knee function, knee pain and major adverse outcomes. DATA COLLECTION AND ANALYSIS: At least two review authors independently selected eligible trials, assessed risk of bias and cross-checked data extraction. Where appropriate, we pooled results of comparable trials. MAIN RESULTS: We included 11 small trials involving 564 adults (aged 16 to 76 years) with patella fractures. There were 340 men and 212 women; the gender of 12 participants was not reported. Seven trials were conducted in China and one each in Finland, Mexico, Pakistan and Turkey. All 11 trials compared different surgical interventions for patella fractures. All trials had design flaws, such as lack of assessor blinding, which put them at high risk of bias, potentially limiting the reliability of their findings. No trial reported on health-related quality of life, return to previous activity or cosmetic appearance. The trials tested one of seven comparisons. In the following, we report those of the main outcomes for which evidence was available for the three most important comparisons. Four trials (174 participants) compared percutaneous osteosynthesis versus open surgery. Very low-quality evidence means that we are uncertain of the findings of no clinically important difference between the two interventions in patient-rated knee function at 12 months (1 study, 50 participants) or in knee pain at intermediate-term follow-up at eight weeks to three months. Furthermore, very low-quality evidence means we are uncertain whether, compared with open surgery, percutaneous fixation surgery reduces the incidence of major adverse outcomes, such as loss of reduction and hardware complications, or results in better observer-rated knee function scores. Two trials (112 participants) compared cable pin system (open or percutaneous surgery) versus tension band technique. The very low-quality evidence means we are uncertain of the findings at one year in favour of the cable pin system of slightly better patient-rated knee function, fewer adverse events and slightly better observer-rated measures of knee function. There was very low-quality evidence of little clinically important between-group difference in knee pain at three months. Very low-quality evidence from two small trials (47 participants) means that we are uncertain of the findings of little difference between biodegradable versus metallic implants at two-year follow-up in the numbers of participants with occasional knee pain, incurring adverse events or with reduced knee motion. There was very low-quality and incomplete evidence from single trials for four other comparisons. This means we are uncertain of the results of one trial (28 participants) that compared patellectomy with advancement of vastus medialis obliquus surgery with simple patellectomy; of one quasi-RCT (56 participants) that compared a new intraoperative reduction technique compared with a standard technique; of one quasi-RCT (65 participants) that compared a modified tension band technique versus the conventional AO tension band wiring (TBW) technique; and of one trial (57 participants) that compared adjustable patella claws and absorbable suture versus Kirschner wire tension band. AUTHORS' CONCLUSIONS: There is very limited evidence from nine RCTs and two quasi-RCTs on the relative effects of different surgical interventions for treating fractures of the patella in adults. There is no evidence from trials evaluating the relative effects of surgical versus conservative treatment or different types of conservative interventions. Given the very low-quality evidence, we are uncertain whether methods of percutaneous osteosynthesis give better results than conventional open surgery; whether cable pin system (open or percutaneous surgery) gives better results than the tension band technique; and whether biodegradable implants are better than metallic implants for displaced patellar fractures. Further randomised trials are needed, but, to optimise research effort, these should be preceded by research that aims to identify priority questions.

Surgical versus conservative interventions for treating fractures of the middle third of the clavicle.

BACKGROUND: Clavicle fractures are common, accounting for 2.6% to 4% of all fractures. Eighty per cent of clavicle fractures are located in the middle third of the clavicle. Although treatment of these fractures is usually non-surgical, displaced clavicle fractures may be considered for surgical treatment because of their greater risk of non-union. This is an update of a Cochrane Review first published in 2013. OBJECTIVES: To assess the effects (benefits and harms) of surgical versus conservative interventions for treating middle third clavicle fractures. SEARCH METHODS: We searched the Cochrane Bone, Joint and Muscle Trauma Specialised Register, CENTRAL, MEDLINE, Embase, LILACS, trials registries and reference lists updated to December 2017. We did not apply any language or publication restrictions. SELECTION CRITERIA: We considered randomised and quasi-randomised controlled trials evaluating surgical versus conservative interventions for treating fractures in the middle third of the clavicle. The primary outcomes were shoulder function or disability, pain and treatment failure, defined as the number of participants who had been given a non-routine secondary surgical intervention (excluding hardware removal), for symptomatic non-union, malunion or other complications. DATA COLLECTION AND ANALYSIS: At least two review authors selected eligible studies, independently assessed risk of bias and cross-checked data. Where appropriate, we pooled results of comparable studies. MAIN RESULTS: We included 14 studies involving 1469 participants with acute middle third clavicle fractures. All studies included adults, with the overall range from 17 to 70 years. Of the studies that reported gender, men were over-represented. Ten studies compared plate fixation with sling or figure-of-eight bandage, or both, and four studies compared intramedullary fixation with wearing either a sling or a figure-of-eight bandage. Almost all studies had design features that carry a high risk of bias, thus limiting the strength of their findings.Low-quality evidence from 10 studies (838 participants), showed that, compared with conservative treatment, surgical treatment of acute middle third clavicle fractures may not improve upper arm function at follow-up of one year or longer: standardised mean difference (SMD) 0.33, 95% confidence interval (CI) -0.02 to 0.67. We downgraded the quality of the evidence because of risk of bias and high statistical heterogeneity (I2 = 83%). This corresponds to a mean improvement of 2.3 points in favour of surgery (0.14 points worse to 4.69 points better), on the 100-point Constant score; this does not represent a clinically important difference. There may be no difference in pain measured using a visual analogue scale (0 to 100 mm; higher scores mean worse pain) between treatments (mean difference (MD) -0.60 mm, 95% CI -3.51 to 2.31; 277 participants, 3 studies; low-quality evidence reflecting risk of bias and imprecision). Surgery may reduce the risk of treatment failure, that is, number of participants who had non-routine secondary surgical intervention (excluding hardware removal), for symptomatic non-union, malunion or other complication (risk ratio (RR) 0.32, 95% CI 0.20 to 0.50; 1197 participants, 12 studies; low-quality evidence, downgraded for risk of bias and imprecision). The main source of treatment failure was mechanical failure (3.4%) in the surgery group and symptomatic non-union (11.6%) in the conservative-treatment group.We are uncertain whether surgery results in fewer people having one or more cosmetic problems, such as deformities, which were more common after conservative treatment, or hardware prominence or scarring, which only occurred in the surgery group (RR 0.55, 95% CI 0.31 to 0.98; 1130 participants, 11 studies; I2 = 63%; very low-quality evidence downgraded for risk of bias, imprecision and inconsistency). We are uncertain whether there is any difference between surgery and conservative treatment in the risk of incurring an adverse outcome that includes local infection, dehiscence, symptomatic malunion, discomfort leading to implant removal, skin and nerve problems: RR 1.34, 95% CI 0.68 to 2.64; 1317 participants, 14 studies; I2 = 72%; very low-quality evidence, downgraded for risk of bias, imprecision and inconsistency). Hardware removal for discomfort was a common adverse outcome in the surgery group (10.2%) while symptomatic malunion was more common in the conservative-treatment group (11.3% versus 1.2% in the surgery group). Infection occurred only in the surgery group (3.2%). There may be no between-group difference in quality of life at one year (SF-12 or SF-36 physical component scores: 0 to 100 scale, where 100 is the best score): MD 0.30 (95% CI -1.95 to 2.56, 321 participants, 2 studies; low-quality evidence downgraded for risk of bias and imprecision). AUTHORS' CONCLUSIONS: There is low-quality evidence that surgical treatment has no additional benefits in terms of function, pain and quality of life compared with conservative treatment, but may result in fewer treatment failures overall. Very low-quality evidence means that we are very uncertain of the findings of a slightly better cosmetic result after surgery and of no difference between surgical and conservative treatment in the risk of adverse events. For both composite outcomes, there is a need to consider the balance of risks between the individual outcomes; for example, surgical adverse events, including wound infection or dehiscence and hardware irritation, against risk of adverse events that may be more commonly associated with conservative treatment such as symptomatic malunion and shoulder stiffness.Treatment options must be chosen on an individual patient basis, after careful consideration of the relative benefits and harms of each intervention and of patient preferences.

Surgical versus conservative interventions for treating acromioclavicular dislocation of the shoulder in adults.

BACKGROUND: Dislocation of the acromioclavicular joint is one of the most common shoulder injuries in a sport-active population. The question of whether surgery should be used remains controversial. This is an update of a Cochrane Review first published in 2010. OBJECTIVES: To assess the effects (benefits and harms) of surgical versus conservative (non-surgical) interventions for treating acromioclavicular dislocations in adults. SEARCH METHODS: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (to June 2019), the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library 2019, Issue 6), MEDLINE (1946 to June 2019), Embase (1980 to June 2019), and LILACS (1982 to June 2019), trial registries, and reference lists of articles. There were no restrictions based on language or publication status. SELECTION CRITERIA: We included all randomised and quasi-randomised trials that compared surgical with conservative treatment of acromioclavicular dislocation in adults. DATA COLLECTION AND ANALYSIS: At least two review authors independently performed study screening and selection, 'Risk of bias' assessment, and data extraction. We pooled data where appropriate and used GRADE to assess the quality of evidence for each outcome. MAIN RESULTS: We included five randomised trials and one quasi-randomised trial. The included trials involved 357 mainly young adults, the majority of whom were male, with acute acromioclavicular dislocation. The strength of the findings in all studies was limited due to design features, invariably lack of blinding, that carry a high risk of bias. Fixation of the acromioclavicular joint using hook plates, tunnelled suspension devices, coracoclavicular screws, acromioclavicular pins, or (usually threaded) wires was compared with supporting the arm in a sling or similar device. After surgery, the arm was also supported in a sling or similar device in all trials. Where described in the trials, both groups had exercise-based rehabilitation. We downgraded the evidence for all outcomes at least two levels, invariably for serious risk of bias and serious imprecision.Low-quality evidence from two studies showed no evidence of a difference between groups in shoulder function at one year, assessed using the Disability of the Arm, Shoulder, and Hand questionnaire (DASH) (0 (best function) to 100 (worst function)): mean difference (MD) 0.73 points, 95% confidence interval (CI) -2.70 to 4.16; 112 participants. These results were consistent with other measures of function at one-year or longer follow-up, including non-validated outcome scores reported by three studies. There is low-quality evidence that function at six weeks may be better after conservative treatment, indicating an earlier recovery. Very low-quality evidence from one trial found no difference between groups in participants reporting pain at one year: risk ratio (RR) 1.32, 95% CI 0.54 to 3.19; 79 participants. There is very low-quality evidence that surgery may not reduce the risk of treatment failure, usually resulting in non-routine secondary surgery: 14/168 versus 15/174; RR 0.99, 95% CI 0.51 to 1.94; 342 participants, 6 studies. The main source of treatment failure was complications related to surgical implants in the surgery group and persistent symptoms, mainly discomfort, due to the acromioclavicular dislocation in the conservatively treated group.There is low-quality evidence from two studies that there may be little or no difference between groups in the return to former activities (sports or work) at one year: 57/67 versus 62/70; RR 0.96, 95% CI 0.85 to 1.10; 137 participants, 2 studies. Low-quality but consistent evidence from four studies indicated an earlier recovery in conservatively treated participants compared with those treated with surgery. There is low-quality evidence of no clinically important difference between groups at one year in quality of life scores, measured using the 36-item or 12-item Short Form Health Survey (SF-36 or SF-12) (0-to-100 scale, where 100 is best score), in either the physical component (MD -0.63, 95% CI -2.63 to 1.37; 122 participants, 2 studies) or mental component (MD 0.47 points, 95% CI -1.51 to 2.44; 122 participants). There is very low-quality and clinically heterogenous evidence of a greater risk of an adverse event after surgery: 45/168 versus 16/174; RR 2.82, 95% CI 1.65 to 4.82; 342 participants, 6 studies; I2 = 48%. Common adverse outcomes were hardware complications or discomfort (18.5%) and infection (8.7%) in the surgery group and persistent symptoms (7.1%), mainly discomfort, in the conservatively treated group. The majority of surgical complications occurred in older studies testing now-outdated devices known for their high risk of complications. The very low-quality evidence from one study (70 participants) means that we are uncertain whether there is a between-group difference in patient dissatisfaction with cosmetic results.It is notable that the evidence for function, return to former activities, and quality of life came from the two most recently conducted studies, which tested currently used devices and interventions in clearly defined participant populations that represented the commonly perceived population for which there is uncertainty over the use of surgery. There were insufficient data to conduct subgroup analysis relating to type of injury and whether surgery involved ligament reconstruction or not. AUTHORS' CONCLUSIONS: There is low-quality evidence that surgical treatment has no additional benefits in terms of function, return to former activities, and quality of life at one year compared with conservative treatment. There is, however, low-quality evidence that people treated conservatively had improved function at six weeks compared with surgical management. There is very low-quality evidence of little difference between the two treatments in pain at one year, treatment failure usually resulting in secondary surgery, or patient satisfaction with cosmetic result. Although surgery may result in more people sustaining adverse events, this varied between the trials, being more common in techniques such as K-wire fixation that are rarely used today. There remains a need to consider the balance of risks between the individual outcomes: for example, surgical adverse events, including wound infection or dehiscence and hardware complication, against risk of adverse events that may be more commonly associated with conservative treatment such as persistent symptoms or discomfort, or both.There is a need for sufficiently powered, good-quality, well-reported randomised trials of currently used surgical interventions versus conservative treatment for well-defined injuries.

Surgery for trigger finger.

BACKGROUND: Trigger finger is a common clinical disorder, characterised by pain and catching as the patient flexes and extends digits because of disproportion between the diameter of flexor tendons and the A1 pulley. The treatment approach may include non-surgical or surgical treatments. Currently there is no consensus about the best surgical treatment approach (open, percutaneous or endoscopic approaches). OBJECTIVES: To evaluate the effectiveness and safety of different methods of surgical treatment for trigger finger (open, percutaneous or endoscopic approaches) in adults at any stage of the disease. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase and LILACS up to August 2017. SELECTION CRITERIA: We included randomised or quasi-randomised controlled trials that assessed adults with trigger finger and compared any type of surgical treatment with each other or with any other non-surgical intervention. The major outcomes were the resolution of trigger finger, pain, hand function, participant-reported treatment success or satisfaction, recurrence of triggering, adverse events and neurovascular injury. DATA COLLECTION AND ANALYSIS: Two review authors independently selected the trial reports, extracted the data and assessed the risk of bias. Measures of treatment effect for dichotomous outcomes calculated risk ratios (RRs), and mean differences (MDs) or standardised mean differences (SMD) for continuous outcomes, with 95% confidence intervals (CIs). When possible, the data were pooled into meta-analysis using the random-effects model. GRADE was used to assess the quality of evidence for each outcome. MAIN RESULTS: Fourteen trials were included, totalling 1260 participants, with 1361 trigger fingers. The age of participants included in the studies ranged from 16 to 88 years; and the majority of participants were women (approximately 70%). The average duration of symptoms ranged from three to 15 months, and the follow-up after the procedure ranged from eight weeks to 23 months.The studies reported nine types of comparisons: open surgery versus steroid injections (two studies); percutaneous surgery versus steroid injection (five studies); open surgery versus steroid injection plus ultrasound-guided hyaluronic acid injection (one study); percutaneous surgery plus steroid injection versus steroid injection (one study); percutaneous surgery versus open surgery (five studies); endoscopic surgery versus open surgery (one study); and three comparisons of types of incision for open surgery (transverse incision of the skin in the distal palmar crease, transverse incision of the skin about 2-3 mm distally from distal palmar crease, and longitudinal incision of the skin) (one study).Most studies had significant methodological flaws and were considered at high or unclear risk of selection bias, performance bias, detection bias and reporting bias. The primary comparison was open surgery versus steroid injections, because open surgery is the oldest and the most widely used treatment method and considered as standard surgery, whereas steroid injection is the least invasive control treatment method as reported in the studies in this review and is often used as first-line treatment in clinical practice.Compared with steroid injection, there was low-quality evidence that open surgery provides benefits with respect to less triggering recurrence, although it has the disadvantage of being more painful. Evidence was downgraded due to study design flaws and imprecision.Based on two trials (270 participants) from six up to 12 months, 50/130 (or 385 per 1000) individuals had recurrence of trigger finger in the steroid injection group compared with 8/140 (or 65 per 1000; range 35 to 127) in the open surgery group, RR 0.17 (95% CI 0.09 to 0.33), for an absolute risk difference that 29% fewer people had recurrence of symptoms with open surgery (60% fewer to 3% more individuals); relative change translates to improvement of 83% in the open surgery group (67% to 91% better).At one week, 9/49 (184 per 1000) people had pain on the palm of the hand in the steroid injection group compared with 38/56 (or 678 per 1000; ranging from 366 to 1000) in the open surgery group, RR 3.69 (95% CI 1.99 to 6.85), for an absolute risk difference that 49% more had pain with open surgery (33% to 66% more); relative change translates to worsening of 269% (585% to 99% worse) (one trial, 105 participants).Because of very low quality evidence from two trials we are uncertain whether open surgery improve resolution of trigger finger in the follow-up at six to 12 months, when compared with steroid injection (131/140 observed in the open surgery group compared with 80/130 in the control group; RR 1.48, 95% CI 0.79 to 2.76); evidence was downgraded due to study design flaws, inconsistency and imprecision. Low-quality evidence from two trials and few event rates (270 participants) from six up to 12 months of follow-up, we are uncertain whether open surgery increased the risk of adverse events (incidence of infection, tendon injury, flare, cutaneous discomfort and fat necrosis) (18/140 observed in the open surgery group compared with 17/130 in the control group; RR 1.02, 95% CI 0.57 to 1.84) and neurovascular injury (9/140 observed in the open surgery group compared with 4/130 in the control group; RR 2.17, 95% CI 0.7 to 6.77). Twelve participants (8 versus 4) did not complete the follow-up, and it was considered that they did not have a positive outcome in the data analysis. We are uncertain whether open surgery was more effective than steroid injection in improving hand function or participant satisfaction as studies did not report these outcomes. AUTHORS' CONCLUSIONS: Low-quality evidence indicates that, compared with steroid injection, open surgical treatment in people with trigger finger, may result in a less recurrence rate from six up to 12 months following the treatment, although it increases the incidence of pain during the first follow-up week. We are uncertain about the effect of open surgery with regard to the resolution rate in follow-up at six to 12 months, compared with steroid injections, due high heterogeneity and few events occurred in the trials; we are uncertain too about the risk of adverse events and neurovascular injury because of a few events occurred in the studies. Hand function or participant satisfaction were not reported.

Second opinion for degenerative spinal conditions: an option or a necessity? A prospective observational study.

BACKGROUND: Second opinions may improve quality of patient care. The primary objective of this study was to determine the concordance between first and second diagnoses and opinions regarding need for spinal surgery among patients with back or neck pain that have been recommended spinal surgery. METHODS: We performed a prospective observational study of patients who had been recommended for spinal surgery and received a second opinion between May 2011 and May 2012 at the Hospital Israelita Albert Einstein on the advice of their health insurance company. A physiatrist and orthopaedic surgeon independently performed the second assessment. If both agreed surgery was indicated, or consensus could not be reached, participants attended a spine review panel for a final recommendation. Descriptive analyses compared diagnoses and management plans of the first and second opinions. RESULTS: Of 544 referred patients, 16 (2.9%) did not meet inclusion criteria, 43 (7.9%) refused participation and 485 were included. Diagnoses differed from the first opinion for 290 (59.8%). Diagnoses of cervical and lumbar radiculopathy were concordant in 36/99 (36.4%) and 116/234 (49.6%) respectively. The second opinion was for conservative treatment for 168 (34.6%) participants, 27 (5.6%) were not considered to have a spine condition, and 290 (59.8%) were referred to the review board. 60 participants did not attend the board review and therefore did not receive a final recommendation. Board review was conservative treatment for an additional 67 participants, 20 were not considered to have a spine condition and 143 participants were recommended surgery. Overall, 33.6% received a final opinion of surgery (143/425) although only 66 (15.5%) received the same surgical recommendation, 235 (55.3%) were advised to have conservative treatment, and 47 (11.1%) were not considered to have a spinal diagnosis. CONCLUSIONS: We found a large discordance between first and second opinions regarding diagnosis and need for spinal surgery. This suggests that obtaining a second opinion could reduce potentially unnecessary surgery. TRIAL REGISTRATION: Current Controlled Trials ISRCTN07143259 . Registered 21 November 2011.

Submuscular double bridge plating for complex distal fractures of the humerus: an alternative, safe, and efficient treatment method.

PURPOSE: The aim of our study is to show the functional outcomes and complication rates of humeral complex fractures in adults, using osteosynthesis with two bridging orthogonal submuscular plates. METHODS: The study consists of a prospective case series of 13 patients with isolated humeral complex fractures treated with two bridging orthogonal submuscular plates. Functional assessment was performed using disabilities of the arm, shoulder, and hand (DASH) score with 30 items. The age ranged from 22 to 68 years, with a mean age of 39 years. Functional assessment with DASH score was performed at the twelfth postoperative week. RESULTS: All patients presented fracture healing in the fourth postoperative month. Of the 13 patients, five (38%) had a DASH score of zero (best function possible). One patient developed neuropraxis and presented with a score of 100 (worst possible). One case developed superficial infection, which was treated with oral antibiotics and local debridement. CONCLUSIONS: This study demonstrated satisfactory functional outcome in patients with distal-third diaphyseal humeral complex fractures treated with two locked submuscular plates. The authors consider it as a safe method and an efficient alternative, especially in younger patients who require early functional recovery.

Conservative interventions for treating middle third clavicle fractures in adolescents and adults.

BACKGROUND: Clavicle (collarbone) fractures account for around 4% of all fractures. Most (76%) clavicle fractures involve the middle-third section of the clavicle. Treatment of these fractures is usually non-surgical (conservative). Commonly used treatments are arm slings, strapping and figure-of-eight bandages.This is an update of a Cochrane review first published in 2009 and updated in 2014. OBJECTIVES: To evaluate the effects (benefits and harms) of different methods for conservative (non-operative) treatment for acute (treated soon after injury) middle third clavicle fractures in adolescents and adults. SEARCH METHODS: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, the Cochrane Central Register of Controlled Trials, MEDLINE (from 1966), Embase (from 1980), LILACS (from 1982), trial registers, orthopaedic proceedings and reference lists of articles. We applied no language or publication restrictions. The date of the last search was 5 January 2016. SELECTION CRITERIA: Randomised and quasi-randomised controlled trials testing conservative interventions for treating adolescents and adults with acute middle third clavicle fractures. The primary outcomes were shoulder function or disability, pain and treatment failure. DATA COLLECTION AND ANALYSIS: For this update, two review authors selected eligible trials, independently assessed risk of bias and cross-checked data extraction. We calculated risk ratios and 95% confidence intervals for dichotomous variables, and mean differences and 95% confidence intervals for continuous variables. There was very limited pooling of data. MAIN RESULTS: We included four trials in this review with 416 participants, who were aged 14 years or above. One new trial was included in this update.Very low quality evidence was available from three trials (296 participants) that compared the figure-of-eight bandage with an arm sling for treating acute middle third clavicle fractures. The three trials were underpowered and compromised by poor methodology. Shoulder function was assessed in different ways in the three trials (data for 51, 61 and 152 participants); each trial provided very low quality evidence of similar shoulder function in the two groups. Pooled data from two trials (203 participants) showed no clinical difference between groups after two weeks in pain (visual analogue scale: 0 (no pain) to 10 (worst pain); mean difference (MD) 0.43, 95% confidence interval (CI) -0.35 to 1.21; I² = 74%; very low quality evidence). A third trial (61 participants) provided very low quality evidence based on a non-validated scoring system of more pain and discomfort during the course of treatment in the figure-of-eight group. Treatment failure, measured in terms of subsequent surgery, was not reported in two trials; the third trial (152 participants) reported one participant in the arm sling group had surgery for secondary plexus nerve palsy. There was very low quality evidence from one trial (148 participants) of little difference in time to clinical fracture healing (MD 0.2 weeks, 95% CI -0.11 to 0.51); data from four non-symptomatic non-unions in the figure-of-eight group were not included. The very low evidence quality data for individual adverse outcomes (poor cosmetic appearance; change in allocated treatment due to pain and discomfort, worsened fracture position on healing; shortening > 15 mm; non-symptomatic non-union and permanent pain) did not confirm a difference between the two groups. There was no clear between group difference in the time to return to school or work activities (MD -0.12 weeks, 95% CI -0.69 to 0.45; 176 participants; very low quality evidence).Moderate quality evidence was available from one trial (120 participants; reporting data for 101 participants), which evaluated therapeutic ultrasound. This trial was at low risk of bias but was underpowered and did not report on shoulder function or quality of life. The trial found no evidence of a difference between low-intensity pulsed ultrasound and placebo in pain, treatment failure (subsequent surgery: 6/52 versus 5/49; RR 1.13, 95% CI 0.37 to 3.47), the time to clinical fracture healing (MD -0.32 days, 95% CI -5.85 to 5.21), adverse events (one case of skin irritation was reported in each group) or time to resume previous activities. AUTHORS' CONCLUSIONS: The current evidence available from randomised controlled trials is insufficient to determine which methods of conservative treatment are the most appropriate for acute middle third clavicle fractures in adolescents and adults. Further research is warranted.

Bioabsorbable versus metallic interference screws for graft fixation in anterior cruciate ligament reconstruction.

BACKGROUND: Anterior cruciate ligament (ACL) tears are frequently treated with surgical reconstruction with grafts, frequently patella tendon or hamstrings. Interference screws are often used to secure the graft in bone tunnels in the femur and tibia. This review examines whether bioabsorbable interference screws give better results than metal interference screws when used for graft fixation in ACL reconstruction. OBJECTIVES: To assess the effects (benefits and harms) of bioabsorbable versus metallic interference screws for graft fixation in ACL reconstruction. SEARCH METHODS: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, CENTRAL (the Cochrane Library), MEDLINE, Embase, LILACS, trial registers and reference lists of articles. Date of search: January 2016. SELECTION CRITERIA: We included randomised controlled trials and quasi-randomised trials comparing bioabsorbable with metallic interferences screws in ACL reconstruction. The main outcomes sought were subjective-rated knee function, failure of treatment, and activity level. DATA COLLECTION AND ANALYSIS: At least two review authors selected eligible trials, independently assessed risk of bias, and cross-checked data. Data were pooled whenever relevant and possible. Requests for further information were sent to the original study authors. MAIN RESULTS: We included 12 trials (11 randomised and one quasi-randomised) involving a total of 944 participants, and reporting follow-up results for 774. Participants in the 12 trials underwent ACL reconstruction with either hamstring tendon grafts (five trials) or patellar tendon grafts (seven trials). Trials participants were randomly allocated to bioabsorbable or metallic interference screws for graft fixation in both femur and tibia (seven trials); femur only (three trials); tibia only (one trial); location was not reported in the remaining trial. A variety of materials was used for the bioabsorbable screws, Poly-L-lactic acid (PLLA) being the most common. The metallic screws, where reported, were titanium.All trials were at high risk of bias, which invariably included performance bias. Seven trials were at high risk of attrition bias and eight at high risk of reporting bias. The quasi-randomised trial was assessed as being at high risk for selection bias. Based on these study limitations and insufficiency of the available data, we judged the quality of evidence for all outcomes was very low.The majority of the available data for patient-reported knee function was presented as Lysholm scores (0 to 100; higher scores = better function). There was very low quality but consistent evidence of no clinically important differences between the two groups in Lysholm scores at 12 months follow-up (mean difference (MD) -0.08, 95% confidence interval (CI) -1.48 to 1.32; three trials, 168 participants); 24 months (MD 0.35, 95% CI -1.27 to 1.98; three trials, 113 participants) or five or more years follow-up (MD 1.23, 95% CI -2.00 to 4.47; two trials, 71 participants). This lack of between-group differences was also reported for Lysholm scores in several trials that did not provide sufficient data for pooling as well as for other self-reported knee function scores reported in several trials.Treatment failure was represented by the summed data for implant breakage during surgery and major postoperative complications (implant failure, graft rupture, symptomatic foreign body reactions, effusion and treated arthrofibrosis and related conditions) that were usually described in the trial reports as requiring further substantive treatment. There is very low-quality evidence of greater treatment failure in the bioabsorbable screw group (60/451 versus 29/434; risk ratio (RR) 1.94 favouring metallic screw fixation, 95% CI 1.29 to 2.93; 885 participants, 11 studies). In a population with an assumed risk (based on the median control group risk) of 56 participants per 1000 having treatment failure after metallic screw fixation, this equates to 53 more (95% CI 17 to 108 more) per 1000 participants having treatment failure after bioabsorbable screw fixation. All 16 intraoperative complications in the bioabsorbable screw group were implant breakages upon screw insertion. Treatment failure defined as postoperative complications only still favoured the metallic screw group but the 95% CI also included the potential for a greater risk of treatment failure after metallic screw fixation: 44/451 versus 29/434; RR 1.44, 95% CI 0.93 to 2.23. Based on the assumed risk of 56 participants per 1000 having postoperative treatment failure after metallic screw fixation, this equates to 25 more (95% CI 4 fewer and 69 more) per 1000 participants having this outcome after bioabsorbable screw fixation.There was very low-quality evidence of very similar activity levels in the two groups at 12 and 24 months follow-up measured via the Tegner score (0 to 10; higher scores = greater activity): 12 months (MD 0.08, 95% CI -0.39 to 0.55; 122 participants, two studies); 24 months (MD 0.01, 95% CI -0.54 to 0.57; 72 participants, two studies). AUTHORS' CONCLUSIONS: There is very low-quality evidence of no difference in self-reported knee function and levels of activity between bioabsorbable and metallic interference screws for graft fixation in ACL reconstruction. There is very low-quality evidence that bioabsorbable screws may be associated with more overall treatment failures, including implant breakage during surgery. Further research does not appear to be a priority, but if undertaken, should also examine costs.

Surgical interventions for treating acute fractures or non-union of the middle third of the clavicle.

BACKGROUND: This review covers two conditions: acute clavicle fractures and non-union resulting from failed fracture healing. Clavicle (collarbone) fractures account for around 4% of all fractures. While treatment for these fractures is usually non-surgical, some types of clavicular fractures, as well as non-union of the middle third of the clavicle, are often treated surgically. This is an update of a Cochrane review first published in 2009. OBJECTIVES: To evaluate the effects (benefits and harms) of different methods of surgical treatment for acute fracture or non-union of the middle third of the clavicle. SEARCH METHODS: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (27 June 2014), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2014, Issue 5), MEDLINE (1966 to June week 3 2014), EMBASE (1988 to 2014 week 25), LILACS (1982 to 27 June 2014), trial registries and reference lists of articles. We applied no language or publication restrictions. SELECTION CRITERIA: We considered randomised and quasi-randomised controlled trials evaluating any surgical intervention for treating people with fractures or non-union of the middle third of the clavicle. The primary outcomes were shoulder function or disability, pain and treatment failure (measured by the number of participants who had undergone or were being considered for a non-routine secondary surgical intervention for symptomatic non-union, malunion or other complications). DATA COLLECTION AND ANALYSIS: Two review authors selected eligible trials, independently assessed risk of bias and cross-checked data. Where appropriate, we pooled results of comparable trials. MAIN RESULTS: We included seven trials in this review with 398 participants. Four trials were new in this update.The four new trials (160 participants) compared intramedullary fixation with open reduction and internal fixation with plate for treating acute middle third clavicle fractures in adults. Low quality evidence from the four trials indicated that intramedullary fixation did not result in a clinically important improvement in upper arm function (despite a statistically significant difference in its favour: standardised mean difference 0.45, 95% confidence interval (CI) 0.08 to 0.81; 120 participants, three trials) at long term follow-up of six months or more. Very low quality evidence indicated little difference between intramedullary fixation and plate fixation in pain (one trial), treatment failure resulting in non-routine surgery (2/68 with intramedullary fixation vs. 3/65 with plate fixation; risk ratio 0.69, 95% CI 0.16 to 2.97, four trials) or time to clinical fracture consolidation (three trials). There was very low quality evidence of a lower incidence of participants with adverse events (mainly infection, poor cosmetic result and symptomatic hardware) in the intramedullary fixation group (18/68 with intramedullary fixation vs. 27/65 with plate fixation; RR 0.64, 95% CI 0.39 to 1.03) but the CI of the pooled results also included the small possibility of a lower incidence in the plate fixation group. None of the four trials reported on quality of life or return to previous activities. Evidence is pending from two ongoing trials, with planned recruitment of 245 participants, testing this comparison.There was low or very low quality evidence from three small trials, each testing a different comparison. The three trials had design features that carried a high risk of bias, potentially limiting the reliability of their findings. Low-contact dynamic compression plates appeared to be associated with significantly better upper-limb function throughout the year following surgery, earlier fracture union and return to work, and a reduced incidence of implant-associated symptoms when compared with a standard dynamic compression plate in 36 adults with symptomatic non-union of the middle third of the clavicle. One quasi-randomised trial (69 participants) compared Knowles pin versus a plate for treating middle third clavicle fractures or non-union. Knowles pins appeared to be associated with lower pain levels and use of postoperative analgesics and a reduced incidence of implant-associated symptoms. One study (133 participants) found that a three-dimensional technique for fixation with a reconstruction plate was associated with a significantly lower incidence of symptomatic delayed union than a standard superior position surgical approach. Evidence is pending from two ongoing trials, with planned recruitment of 130 participants, comparing anterior versus superior plates for acute fractures. AUTHORS' CONCLUSIONS: There is very limited and low quality evidence available from randomised controlled trials regarding the effectiveness of different methods of surgical fixation of fractures and non-union of the middle third of the clavicle. The evidence from four ongoing trials is likely to inform practice for the comparisons of intramedullary versus plate fixation and anterior versus superior plates for acute fractures in a future update. Further randomised trials are warranted, but in order to optimise research effort, these should be preceded by research that aims to identify priority questions.

Interventions for treating fractures of the patella in adults.

BACKGROUND: Fractures of the patella (kneecap) account for around 1% of all human fractures. The treatment of these fractures can be surgical or conservative (such as immobilisation with a cast or brace). There are many different surgical and conservative interventions for treating fractures of the patella in adults. OBJECTIVES: To assess the effects (benefits and harms) of interventions (surgical and conservative) for treating fractures of the patella in adults. SEARCH METHODS: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (2 May 2014), the Cochrane Central Register of Controlled Trials (The Cochrane Library, 2014, Issue 4), MEDLINE (1946 to April Week 4 2014), Ovid MEDLINE In-Process & Other Non-Indexed Citations (2 May 2014), Embase (1980 to 2014 Week 17), LILACS (1982 to 2 May 2014), trial registers and references lists of articles. SELECTION CRITERIA: Randomised controlled trials (RCTs) or quasi-RCTs that evaluated any surgical or conservative intervention for treating adults with fractures of the patella were eligible for inclusion. The primary outcomes were patient-rated knee function and knee pain, and major adverse outcomes. DATA COLLECTION AND ANALYSIS: At least two review authors independently selected eligible trials, assessed risk of bias and cross-checked data extraction. Where appropriate, results of comparable trials were pooled. MAIN RESULTS: We included five small trials involving 169 participants with patella fractures. Participant age ranged from 16 to 76 years. There were 68 females and 100 males; the gender of one participant was not reported. Two trials were conducted in China and one each in Finland, Mexico and Turkey.All five trials compared different surgical interventions. Two trials compared biodegradable versus metallic implants for treating displaced patella fractures; one trial compared patellectomy with advancement of vastus medialis obliquus versus simple patellectomy for treating comminuted patella fractures; and two trials compared percutaneous osteosynthesis (both procedures were 'novel' and one used a new device) versus open surgery for treating displaced patella fractures. All the trials had design flaws, such as lack of assessor blinding, which put them at high risk of bias, potentially limiting the reliability of their findings. No trial reported on health-related quality of life, return to previous activity or cosmetic appearance.Very low quality evidence from two trials (48 participants) comparing biodegradable versus metallic implants indicated little difference between the two interventions at two-year follow-up in the numbers of participants with occasional knee pain (1/23 versus 2/24), incurring adverse events (3/24 versus 1/24) or with reduced knee motion (2/23 versus 2/24). Neither trial reported patient-rated knee function scores. In one trial, as per routine practice, metallic implants were removed one year after surgery (four participants). The other trial did not report on this aspect.Very low quality evidence from one trial (28 participants) indicated that compared with simple patellectomy, patellectomy with advancement of vastus medialis obliquus surgery for treating comminuted patella fractures resulted in more participants with a 'good' result based on a subjectively rated score (12/12 versus 11/16; risk ratio (RR) 1.42, 95% confidence interval (CI) 1.01 to 2.01), fewer participants experiencing knee pain (5/12 versus 13/16; RR 3.11, 95% CI 1.01 to 9.60) and more participants with unlimited activity and no loss in quadriceps strength at four-year follow-up. The only adverse event reported was a patellar tendon subluxation in the simple patellectomy group.Neither trial comparing percutaneous osteosynthesis (using novel devices or methods) versus open surgery reported on patient-rated knee function scores. Very low quality evidence from two trials (93 participants) showed that percutaneous osteosynthesis improved knee pain measured using visual analogue scale (0 to 10 where 10 is worst pain) at one month (mean difference (MD) -2.24, 95% CI -2.80 to -1.68) and at up to three months (MD -1.87, 95% CI -2.45 to -1.29). This effect did not persist at six months (very low quality evidence from one trial). Very low quality evidence from the two trials showed significantly fewer participants with adverse events (loss of reduction, infection, hardware complications, delayed wound healing) after percutaneous surgery (8/47 versus 28/46; RR 0.28, 95% CI 0.14 to 0.55). Very low quality evidence from the two trials indicated better clinician-rated knee function scores after percutaneous fixation at two to three months and 12 months follow-up; however, the between-group difference was not clinically important at 24 months. Very low quality evidence showed a lower incidence of hardware removal in the percutaneous group at two years; however, the results in the two trials were heterogeneous and the reasons for removal were not given in detail. AUTHORS' CONCLUSIONS: There is very limited evidence from RCTs about the relative effects of different surgical interventions for treating fractures of the patella in adults. There is no evidence from RCTs evaluating the relative effects of surgical versus conservative treatment or different types of conservative interventions.Based on very low quality evidence, biodegradable implants seem to be no better than metallic implants for displaced patellar fractures; patellectomy with vastus medialis obliquus advancement may give better results than simple patellectomy for comminuted patellar fractures; and two novel methods of percutaneous osteosynthesis may give better results than conventional open surgery. However, until conclusive evidence becomes available, treatment options must be chosen on an individual patient basis, carefully considering the relative benefits and harms of each intervention and patient preferences. Further randomised trials are needed, but in order to optimise research effort, these should be preceded by research that aims to identify priority questions.

Conservative interventions for treating middle third clavicle fractures in adolescents and adults.

BACKGROUND: Clavicle (collarbone) fractures account for around 4% of all fractures; treatment of these fractures is usually non-surgical (conservative). Commonly used treatments are arm slings, strapping, figure-of-eight bandages and splints.This is an update of a Cochrane review first published in 2009. OBJECTIVES: To evaluate the effects of different methods for conservative (non-operative) treatment for acute (treated soon after injury) middle third clavicle fractures in adolescents and adults. SEARCH METHODS: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, the Cochrane Central Register of Controlled Trials (2013, Issue 12), MEDLINE (from 1966), EMBASE (from 1980), LILACS (from 1982), trial registers, orthopaedic proceedings and reference lists of articles. We applied no language or publication restrictions. The date of the last search was 29 January 2014. SELECTION CRITERIA: Randomised and quasi-randomised controlled trials testing conservative interventions for treating adolescents and adults with acute middle third clavicle fractures. The primary outcomes were shoulder function or disability, pain and treatment failure. DATA COLLECTION AND ANALYSIS: At least two authors selected eligible trials, independently assessed risk of bias and cross-checked data extraction. We calculated risk ratios and 95% confidence intervals for dichotomous variables, and mean differences and 95% confidence intervals for continuous variables. There was no pooling of data. MAIN RESULTS: We included three trials in this review with 354 participants. No new trials were included in this update.Very low quality evidence was available from two trials (234 participants) that compared the figure-of-eight bandage with an arm sling for treating acute middle third clavicle fractures. Both trials were underpowered and compromised by poor methodology. One trial found slightly higher pain levels in the bandage group at 15 days (mean difference 0.80, 95% confidence interval 0.34 to 1.26; visual analogue scale: 0 (no pain) to 10 (worst pain)); and the other trial reported greater discomfort during bandage wear. There were no significant differences between the two interventions in functional or other outcomes reported for either trial.Moderate quality evidence was available from the third trial (120 participants), which evaluated therapeutic ultrasound. This trial was at low risk of any type of bias but was underpowered. The trial found no statistically significant difference between low-intensity pulsed ultrasound and placebo in the time to clinical fracture healing (mean difference -0.32 days, 95% CI -5.85 to 5.21 days), nor in any of the other reported outcomes. AUTHORS' CONCLUSIONS: There is limited evidence available from randomised controlled trials to determine which methods of conservative treatment are the most appropriate for acute middle third clavicle fractures in adolescents and adults. Further research is warranted.

Platelet-rich therapies for musculoskeletal soft tissue injuries.

BACKGROUND: Platelet-rich therapies are being used increasingly in the treatment of musculoskeletal soft tissue injuries such as ligament, muscle and tendon tears and tendinopathies. These therapies can be used as the principal treatment or as an augmentation procedure (application after surgical repair or reconstruction). Platelet-rich therapies are produced by centrifuging a quantity of the patient's own blood and extracting the active, platelet-rich, fraction. The platelet-rich fraction is applied to the injured tissue; for example, by injection. Platelets have the ability to produce several growth factors, so these therapies should enhance tissue healing. There is a need to assess whether this translates into clinical benefit. OBJECTIVES: To assess the effects (benefits and harms) of platelet-rich therapies for treating musculoskeletal soft tissue injuries. SEARCH METHODS: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (25 March 2013), the Cochrane Central Register of Controlled Trials (CENTRAL 2013 Issue 2), MEDLINE (1946 to March 2013), EMBASE (1980 to 2013 Week 12) and LILACS (1982 to March 2012). We also searched trial registers (to Week 2 2013) and conference abstracts (2005 to March 2012). No language or publication restrictions were applied. SELECTION CRITERIA: We included randomised and quasi-randomised controlled trials that compared platelet-rich therapy with either placebo, autologous whole blood, dry needling or no platelet-rich therapy for people with acute or chronic musculoskeletal soft tissue injuries. Primary outcomes were functional status, pain and adverse effects. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed each study's risk of bias. Disagreement was resolved by discussion or by arbitration by a third author. We contacted trial authors for clarification of methods or missing data. Treatment effects were assessed using risk ratios for dichotomous data and mean differences (MD) or standardised mean differences (SMD) for continuous data, together with 95% confidence intervals. Where appropriate, data were pooled using the fixed-effect model for RR and MD, and the random-effects model for SMD. The quality of the evidence for each outcome was assessed using GRADE criteria. MAIN RESULTS: We included data from 19 small single centre trials (17 randomised and two quasi-randomised; 1088 participants) that compared platelet-rich therapy with placebo, autologous whole blood, dry needling or no platelet-rich therapy. These trials covered eight clinical conditions: rotator cuff tears (arthroscopic repair) (six trials); shoulder impingement syndrome surgery (one trial); elbow epicondylitis (three trials); anterior cruciate ligament (ACL) reconstruction (four trials), ACL reconstruction (donor graft site application) (two trials), patellar tendinopathy (one trial), Achilles tendinopathy (one trial) and acute Achilles rupture surgical repair (one trial). We also grouped trials into 'tendinopathies' where platelet-rich therapy (PRT) injections were the main treatment (five trials), and surgical augmentation procedures where PRT was applied during surgery (14 trials). Trial participants were mainly male, except in trials including rotator cuff tears, and elbow and Achilles tendinopathies.Three trials were judged as being at low risk of bias; the other 16 were at high or unclear risk of bias relating to selection, detection, attrition or selective reporting, or combinations of these. The methods of preparing platelet-rich plasma (PRP) varied and lacked standardisation and quantification of the PRP applied to the patient.We were able to pool data for our primary outcomes (function, pain, adverse events) for a maximum of 11 trials and 45% of participants. The evidence for all primary outcomes was judged as being of very low quality.Data assessing function in the short term (up to three months) were pooled from four trials that assessed PRT in three clinical conditions and used four different measures. These showed no significant difference between PRT and control (SMD 0.26; 95% confidence interval (CI) -0.19 to 0.71; P value 0.26; I² = 51%; 162 participants; positive values favour PRT). Medium-term function data (at six months) were pooled from five trials that assessed PRT in five clinical conditions and used five different measures. These also showed no difference between groups (SMD -0.09, 95% CI -0.56 to 0.39; P value 0.72; I² = 50%; 151 participants). Long-term function data (at one year) were pooled from 10 trials that assessed PRT in five clinical conditions and used six different measures. These also showed no difference between groups (SMD 0.25, 95% CI -0.07 to 0.57; P value 0.12; I² = 66%; 484 participants). Although the 95% confidence intervals indicate the possibility of a poorer outcome in the PRT group up to a moderate difference in favour of PRT at short- and long-term follow-up, these do not translate into clinically relevant differences.Data pooled from four trials that assessed PRT in three clinical conditions showed a small reduction in short-term pain in favour of PRT on a 10-point scale (MD -0.95, 95% CI -1.41 to -0.48; I² = 0%; 175 participants). The clinical significance of this result is marginal.Four trials reported adverse events; another seven trials reported an absence of adverse events. There was no difference between treatment groups in the numbers of participants with adverse effects (7/241 versus 5/245; RR 1.31, 95% CI 0.48 to 3.59; I² = 0%; 486 participants).In terms of individual conditions, we pooled heterogeneous data for long-term function from six trials of PRT application during rotator cuff tear surgery. This showed no statistically or clinically significant differences between the two groups (324 participants).The available evidence is insufficient to indicate whether the effects of PRT will differ importantly in individual clinical conditions. AUTHORS' CONCLUSIONS: Overall, and for the individual clinical conditions, there is currently insufficient evidence to support the use of PRT for treating musculoskeletal soft tissue injuries. Researchers contemplating RCTs should consider the coverage of currently ongoing trials when assessing the need for future RCTs on specific conditions. There is need for standardisation of PRP preparation methods.

Robot-assisted knee arthroplasty: Analyzing the learning curve and initial institutional experience.

Robot-assisted total knee arthroplasty (rTKA) involves a learning curve for orthopedic surgeons. The aim of the present study was to assess the surgical times of rTKA procedures performed by initial stage and proficiency stage surgeons in comparison with times of conventional total knee arthroplasty (cTKA). The results reveal that the learning curve for rTKA varies considerable between surgeons, suggesting that the skill and aptitude of the individual to adapt to the robotic system play key roles in the learning process. Proficiency stage surgeons were able to reduce rTKA surgical times to levels comparable with those of conventional surgeries after performing approximately 30 to 40 robotic procedures. Ongoing research has shown promising outcomes in terms of improved clinical results and reduced complications following the application of advanced robotic technology to total knee arthroplasty.

Bacterial identification in herniated intervertebral discs: a prospective cohort study.

BACKGROUND CONTEXT: Reports of Cutibacterium acnes isolated in cultures of intervertebral disc samples suggest it as possibly responsible for inflammatory conditions causing Modic changes on spinal magnetic resonance imaging (MRI). PURPOSE: Our objective was to investigate the prevalence of C. acnes in samples of intervertebral disc of patients with lumbar disc herniation; to investigate prognostic factors and the relationship of Modic changes with infection 1 year after microdiscectomy. STUDY DESIGN: Prospective cohort study. PATIENT SAMPLE: In this single-center study, patients consecutively operated on for disc herniation had samples of the disc, multifidus muscle and ligamentum flavum (as an indication of contamination) extracted for culture. OUTCOME MEASURES: Age, sex, alcohol and tobacco consumption, body mass index; function, pain, and Modic chances in MRI before surgery and MRI 1 year later; rate of disc, muscle and ligament infection (primary outcome); diabetes and corticoid use (confoundings). METHODS: The protruded disc, muscle and ligament samples were sent for culture analysis in up to 30 minutes. A subsample of 17 patients underwent next-generation sequencing (NGS) molecular analysis too. We performed descriptive analysis and comparison of groups of patients with and without infection or contamination using Student's t, Mann-Whitney, chi-square, or Fisher's exact tests as appropriate, and pre- and postsurgical comparisons with the Wilcoxon test. RESULTS: From January 2018 to September 2019, 112 patients underwent open lumbar microdiscectomy, 67 (59.8%) men. Cultures showed 7 (6.3%) positive cases in the disc (2 with C. acnes), 3 (2.7%) in the ligament, and 12 (10, 7%) in muscle. No evidence of a difference in Modic alterations pre- or postoperatively was found between patients with and without positive culture 1 year after surgery. No association was found between culture positivity and functional or pain differences either. NGS results were all negative for C. acnes. CONCLUSIONS: We identified infective bacterial presence in the herniated disc in less than 2% of patients with disc herniation. C. acnes was not identified in any disc microbiome analysis. No significant association was observed between positivity for tissue infection and any clinical prognostic factor.

Surgical versus conservative interventions for treating fractures of the middle third of the clavicle.

BACKGROUND: Clavicle fractures are common, accounting for 2.6% to 4% of all fractures. Eighty per cent of clavicle fractures are located in the middle third of the clavicle. Although treatment of these fractures is usually non-surgical, displaced clavicle fractures may be considered for surgical treatment because of their greater risk of non-union. OBJECTIVES: To assess the effects (benefits and harms) of surgical versus conservative interventions for treating middle third clavicle fractures. SEARCH METHODS: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (to December 2012), Cochrane Central Register of Controlled Trials (CENTRAL; in The Cochrane Library 2012, Issue 11), MEDLINE (1966 to December 2012), EMBASE (1980 to 2012 Week 40), LILACS (1982 to December 2012), and trial registries (December 2012). No language or publication restrictions were applied. SELECTION CRITERIA: Randomised and quasi-randomised controlled trials evaluating surgical versus conservative interventions for treating middle third of the clavicle fractures were considered. The primary outcomes were shoulder function or disability, pain and treatment failure (defined as the number of participants who had been given a non-routine secondary surgical intervention (excluding hardware removal) for symptomatic non-union, malunion or other complications). DATA COLLECTION AND ANALYSIS: At least two review authors selected eligible trials, independently assessed risk of bias and cross-checked data. Where appropriate, results of comparable trials were pooled. MAIN RESULTS: We included eight trials involving 555 participants with middle third clavicle fractures. Four studies compared plate fixation with wearing a sling and four studies compared intramedullary fixation with wearing either a sling or a figure-of-eight bandage. Almost all trials had design features that carry a high risk of bias, thus limiting the strength of their findings.Low-quality evidence from seven trials (429 participants) showed that, compared with conservative treatment, surgical treatment of acute middle third clavicle fractures may not result in a significant improvement in upper arm function at one year of more follow-up: standardised mean difference 0.46, 95% confidence interval (CI) CI -0.06 to 0.98. This corresponds to an absolute mean improvement of 3.2 points in favour of surgery (0.4 points worse to 7 points improvement) on the 100-point Constant score; this is neither clinically nor statistically significant. Low-quality evidence from seven trials (437 participants) indicates a marginal difference in the incidence of treatment failure between surgery (9/232, 3.9%) and conservative treatment (24/205, 11.7%) (risk ratio 0.38, 95% CI 0.15 to 0.99). However, this was dominated by the results of the largest trial, which had an unusually high number of symptomatic malunions in the conservative treatment group. One trial providing pain results at one-year follow-up found no difference between the two groups. No trials reported on quality of life.No significant difference between groups was noted in the pooled results for adverse events but separate analyses by type of adverse events showed that wound infection and/or dehiscence (data from three trials) and secondary surgery due to hardware complications (data from five trials) occurred only in the surgical group. Skin and nerve problems were also more common after surgical treatment, although the difference between the two groups was not statistically significant (data from four trials). Conversely, stiffness or restriction of shoulder movement was more common after conservative treatment (data from three trials). AUTHORS' CONCLUSIONS: Limited evidence is available from randomised controlled trials on the relative effectiveness of surgical versus conservative treatment for acute middle third clavicle fractures. Treatment options must be chosen on an individual patient basis, after careful consideration of the relative benefits and harms of each intervention and of patient preferences.

Physical tests for shoulder impingements and local lesions of bursa, tendon or labrum that may accompany impingement.

BACKGROUND: Impingement is a common cause of shoulder pain. Impingement mechanisms may occur subacromially (under the coraco-acromial arch) or internally (within the shoulder joint), and a number of secondary pathologies may be associated. These include subacromial-subdeltoid bursitis (inflammation of the subacromial portion of the bursa, the subdeltoid portion, or both), tendinopathy or tears affecting the rotator cuff or the long head of biceps tendon, and glenoid labral damage. Accurate diagnosis based on physical tests would facilitate early optimisation of the clinical management approach. Most people with shoulder pain are diagnosed and managed in the primary care setting. OBJECTIVES: To evaluate the diagnostic accuracy of physical tests for shoulder impingements (subacromial or internal) or local lesions of bursa, rotator cuff or labrum that may accompany impingement, in people whose symptoms and/or history suggest any of these disorders. SEARCH METHODS: We searched electronic databases for primary studies in two stages. In the first stage, we searched MEDLINE, EMBASE, CINAHL, AMED and DARE (all from inception to November 2005). In the second stage, we searched MEDLINE, EMBASE and AMED (2005 to 15 February 2010). Searches were delimited to articles written in English. SELECTION CRITERIA: We considered for inclusion diagnostic test accuracy studies that directly compared the accuracy of one or more physical index tests for shoulder impingement against a reference test in any clinical setting. We considered diagnostic test accuracy studies with cross-sectional or cohort designs (retrospective or prospective), case-control studies and randomised controlled trials. DATA COLLECTION AND ANALYSIS: Two pairs of review authors independently performed study selection, assessed the study quality using QUADAS, and extracted data onto a purpose-designed form, noting patient characteristics (including care setting), study design, index tests and reference standard, and the diagnostic 2 x 2 table. We presented information on sensitivities and specificities with 95% confidence intervals (95% CI) for the index tests. Meta-analysis was not performed. MAIN RESULTS: We included 33 studies involving 4002 shoulders in 3852 patients. Although 28 studies were prospective, study quality was still generally poor. Mainly reflecting the use of surgery as a reference test in most studies, all but two studies were judged as not meeting the criteria for having a representative spectrum of patients. However, even these two studies only partly recruited from primary care.The target conditions assessed in the 33 studies were grouped under five main categories: subacromial or internal impingement, rotator cuff tendinopathy or tears, long head of biceps tendinopathy or tears, glenoid labral lesions and multiple undifferentiated target conditions. The majority of studies used arthroscopic surgery as the reference standard. Eight studies utilised reference standards which were potentially applicable to primary care (local anaesthesia, one study; ultrasound, three studies) or the hospital outpatient setting (magnetic resonance imaging, four studies). One study used a variety of reference standards, some applicable to primary care or the hospital outpatient setting. In two of these studies the reference standard used was acceptable for identifying the target condition, but in six it was only partially so. The studies evaluated numerous standard, modified, or combination index tests and 14 novel index tests. There were 170 target condition/index test combinations, but only six instances of any index test being performed and interpreted similarly in two studies. Only two studies of a modified empty can test for full thickness tear of the rotator cuff, and two studies of a modified anterior slide test for type II superior labrum anterior to posterior (SLAP) lesions, were clinically homogenous. Due to the limited number of studies, meta-analyses were considered inappropriate. Sensitivity and specificity estimates from each study are presented on forest plots for the 170 target condition/index test combinations grouped according to target condition. AUTHORS' CONCLUSIONS: There is insufficient evidence upon which to base selection of physical tests for shoulder impingements, and local lesions of bursa, tendon or labrum that may accompany impingement, in primary care. The large body of literature revealed extreme diversity in the performance and interpretation of tests, which hinders synthesis of the evidence and/or clinical applicability.

Platelet-rich therapies for musculoskeletal soft tissue injuries.

BACKGROUND: Platelet-rich therapies are being used increasingly in the treatment of musculoskeletal soft tissue injuries such as ligament, muscle and tendon tears and tendinopathies. These therapies can be used as the principal treatment or as an augmentation procedure (application after surgical repair or reconstruction). Platelet-rich therapies are produced by centrifuging a quantity of the patient's own blood and extracting the active, platelet-rich, fraction. The platelet-rich fraction is applied to the injured tissue; for example, by injection. Platelets have the ability to produce several growth factors, so these therapies should enhance tissue healing. There is a need to assess whether this translates into clinical benefit. OBJECTIVES: To assess the effects (benefits and harms) of platelet-rich therapies for treating musculoskeletal soft tissue injuries. SEARCH METHODS: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (25 March 2013), the Cochrane Central Register of Controlled Trials (CENTRAL 2013 Issue 2), MEDLINE (1946 to March 2013), EMBASE (1980 to 2013 Week 12) and LILACS (1982 to March 2012). We also searched trial registers (to Week 2 2013) and conference abstracts (2005 to March 2012). No language or publication restrictions were applied. SELECTION CRITERIA: We included randomised and quasi-randomised controlled trials that compared platelet-rich therapy with either placebo, autologous whole blood, dry needling or no platelet-rich therapy for people with acute or chronic musculoskeletal soft tissue injuries. Primary outcomes were functional status, pain and adverse effects. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed each study's risk of bias. Disagreement was resolved by discussion or by arbitration by a third author. We contacted trial authors for clarification of methods or missing data. Treatment effects were assessed using risk ratios for dichotomous data and mean differences (MD) or standardised mean differences (SMD) for continuous data, together with 95% confidence intervals. Where appropriate, data were pooled using the fixed-effect model for RR and MD, and the random-effects model for SMD. The quality of the evidence for each outcome was assessed using GRADE criteria. MAIN RESULTS: We included data from 19 small single centre trials (17 randomised and two quasi-randomised; 1088 participants) that compared platelet-rich therapy with placebo, autologous whole blood, dry needling or no platelet-rich therapy. These trials covered eight clinical conditions: rotator cuff tears (arthroscopic repair) (six trials); shoulder impingement syndrome surgery (one trial); elbow epicondylitis (three trials); anterior cruciate ligament (ACL) reconstruction (four trials), ACL reconstruction (donor graft site application) (two trials), patellar tendinopathy (one trial), Achilles tendinopathy (one trial) and acute Achilles rupture surgical repair (one trial). We also grouped trials into 'tendinopathies' where platelet-rich therapy (PRT) injections were the main treatment (five trials), and surgical augmentation procedures where PRT was applied during surgery (14 trials). Trial participants were mainly male, except in trials including rotator cuff tears, and elbow and Achilles tendinopathies.Three trials were judged as being at low risk of bias; the other 16 were at high or unclear risk of bias relating to selection, detection, attrition or selective reporting, or combinations of these. The methods of preparing platelet-rich plasma (PRP) varied and lacked standardisation and quantification of the PRP applied to the patient.We were able to pool data for our primary outcomes (function, pain, adverse events) for a maximum of 11 trials and 45% of participants. The evidence for all primary outcomes was judged as being of very low quality.Data assessing function in the short term (up to three months) were pooled from five trials that assessed PRT in three clinical conditions and used four different measures. These showed no significant difference between PRT and control (SMD 0.24; 95% confidence interval (CI) -0.07 to 0.56; P value 0.13; I² = 35%; 273 participants; positive values favour PRT). Medium-term function data (at six months) were pooled from six trials that assessed PRT in five clinical conditions and used six different measures. These also showed no difference between groups (SMD 0.06; 95% CI -0.39 to 0.51; P value 0.79; I² = 64%; 262 participants). Long-term function data (at one year) were pooled from 10 trials that assessed PRT in five clinical conditions and used six different measures. These also showed no difference between groups (SMD 0.25, 95% CI -0.07 to 0.57; P value 0.12; I² = 66%; 484 participants). Although the 95% confidence intervals indicate the possibility of a slightly poorer outcome in the PRT group up to a moderate difference in favour of PRT at short- and long-term follow-up, these do not translate into clinically relevant differences.Data pooled from four trials that assessed PRT in three clinical conditions showed a small reduction in short-term pain in favour of PRT on a 10-point scale (MD -0.95, 95% CI -1.41 to -0.48; I² = 0%; 175 participants). The clinical significance of this result is marginal.Four trials reported adverse events; another seven trials reported an absence of adverse events. There was no difference between treatment groups in the numbers of participants with adverse effects (7/241 versus 5/245; RR 1.31, 95% CI 0.48 to 3.59; I² = 0%; 486 participants).In terms of individual conditions, we pooled heterogeneous data for long-term function from six trials of PRT application during rotator cuff tear surgery. This showed no statistically or clinically significant differences between the two groups (324 participants). Pooled data for short-term function for three elbow epicondylitis trials (179 participants) showed a statistically significant difference in favour of PRT, but the clinical significance of this finding is uncertain.The available evidence is insufficient to indicate whether the effects of PRT will differ importantly in individual clinical conditions. AUTHORS' CONCLUSIONS: Overall, and for the individual clinical conditions, there is currently insufficient evidence to support the use of PRT for treating musculoskeletal soft tissue injuries. Researchers contemplating RCTs should consider the coverage of currently ongoing trials when assessing the need for future RCTs on specific conditions. There is need for standardisation of PRP preparation methods.

Magnetic resonance imaging, magnetic resonance arthrography and ultrasonography for assessing rotator cuff tears in people with shoulder pain for whom surgery is being considered.

BACKGROUND: Shoulder pain is a very common symptom. Disorders of the rotator cuff tendons due to wear or tear are among the most common causes of shoulder pain and disability. Magnetic resonance imaging (MRI), magnetic resonance arthrography (MRA) and ultrasound (US) are increasingly being used to assess the presence and size of rotator cuff tears to assist in planning surgical treatment. It is not known whether one imaging method is superior to any of the others. OBJECTIVES: To compare the diagnostic test accuracy of MRI, MRA and US for detecting any rotator cuff tears (i.e. partial or full thickness) in people with suspected rotator cuff tears for whom surgery is being considered. SEARCH METHODS: We searched the Cochrane Register of Diagnostic Test Accuracy Studies, MEDLINE, EMBASE, and LILACS from inception to February 2011. We also searched trial registers, conference proceedings and reference lists of articles to identify additional studies. No language or publication restrictions were applied. SELECTION CRITERIA: We included all prospective diagnostic accuracy studies that assessed MRI, MRA or US against arthroscopy or open surgery as the reference standard, in people suspected of having a partial or full thickness rotator cuff tear. We excluded studies that selected a healthy control group, or participants who had been previously diagnosed with other specific causes of shoulder pain such as osteoarthritis or rheumatoid arthritis. Studies with an excessively long period (a year or longer) between the index and reference tests were also excluded. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data on study characteristics and results of included studies, and performed quality assessment according to QUADAS criteria. Our unit of analysis was the shoulder. For each test, estimates of sensitivity and specificity from each study were plotted in ROC space and forest plots were constructed for visual examination of variation in test accuracy. Meta-analyses were performed using the bivariate model to produce summary estimates of sensitivity and specificity. We were unable to formally investigate potential sources of heterogeneity because of the small number of studies. MAIN RESULTS: We included 20 studies of people with suspected rotator cuff tears (1147 shoulders), of which six evaluated MRI and US (252 shoulders), or MRA and US (127 shoulders) in the same people. Many studies had design flaws, with the potential for bias, thus limiting the reliability of their findings. Overall, the methodological quality of the studies was judged to be low or unclear. For each test, we observed considerable heterogeneity in study results, especially between studies that evaluated US for the detection of full thickness tears and studies that evaluated MRA for the detection of partial thickness tears. The criteria for a positive diagnostic test (index tests and reference standard) varied between studies.Meta-analyses were not possible for studies that assessed MRA for detection of any rotator cuff tears or partial thickness tears. We found no statistically significant differences in sensitivity or specificity between MRI and US for detecting any rotator cuff tears (P = 0.13), or for detecting partial thickness tears (P = 1.0). Similarly, for the comparison between MRI, MRA and US for detecting full thickness tears, there was no statistically significant difference in diagnostic performance (P = 0.7). For any rotator cuff tears, the summary sensitivity and specificity were 98% (95% CI 92% to 99%) and 79% (95% CI 68% to 87%) respectively for MRI (6 studies, 347 shoulders), and 91% (95% CI 83% to 95%) and 85% (95% CI 74% to 92%) respectively for US (13 studies, 854 shoulders). For full thickness tears, the summary sensitivity and specificity were 94% (95% CI 85% to 98%) and 93% (95% CI 83% to 97%) respectively for MRI (7 studies, 368 shoulders); 94% (95% CI 80% to 98%) and 92% (95% CI 83% to 97%) respectively for MRA (3 studies, 183 shoulders); and 92% (95% CI 82% to 96%) and 93% (95% CI 81% to 97%) respectively for US (10 studies, 729 shoulders).Because few studies were direct head-to-head comparisons, we could not perform meta-analyses restricted to these studies. The test comparisons for each of the three classifications of the target condition were therefore based on indirect comparisons which may be prone to bias due to confounding. AUTHORS' CONCLUSIONS: MRI, MRA and US have good diagnostic accuracy and any of these tests could equally be used for detection of full thickness tears in people with shoulder pain for whom surgery is being considered. The diagnostic performance of MRI and US may be similar for detection of any rotator cuff tears. However, both MRI and US may have poor sensitivity for detecting partial thickness tears, and the sensitivity of US may be much lower than that of MRI. The strength of evidence for all test comparisons is limited because most studies were small, heterogeneous and methodologically flawed, and there were few comparative studies. Well designed studies that directly compare MRI, MRA and US for detection of rotator cuff tears are needed.

How Does Platelet-Rich Plasma Compare Clinically to Other Therapies in the Treatment of Knee Osteoarthritis? A Systematic Review and Meta-analysis.

BACKGROUND: There has been an increase in interest in the use of biological therapies in orthopaedic conditions such as knee osteoarthritis. Platelet-rich plasma (PRP) is one of these therapies, but it still lacks consistent results. PURPOSE: To evaluate the effects (benefits and harms) of PRP intra-articular injection compared with other nonsurgical methods for the treatment of knee osteoarthritis. STUDY DESIGN: Systematic review and meta-analysis of randomized and quasi-randomized controlled trials; Level of evidence, 2. METHODS: Three electronic databases were searched to identify relevant studies published before January 2021. The primary outcomes were pain, function, and failure of treatment. Risks of bias of all trials were assessed using a Cochrane risk of bias tool. The Grading of Recommendations Assessment, Development and Evaluation System was used to assess the quality of evidence of included studies. RESULTS: A total of 40 studies with 3035 participants were included. Analysis of this review focused on comparing PRP with hyaluronic acid, corticosteroid, and saline, as we believe they are the most relevant comparisons with the most studies available. At 6-month follow-up, PRP was as effective as and in some studies more effective than other therapies regarding pain, function, and stiffness. However, current evidence is of low or very low quality and is based on trials with high risk of bias and great heterogeneity among them. No significant difference among treatments was found concerning major adverse events and treatment failure. CONCLUSION: Although studies suggest that PRP may be more effective than or at least as effective as other modalities of nonsurgical treatment for knee osteoarthritis in terms of pain, function, and adverse events, serious limitations and methodological flaws are considerable in the current literature. Therefore, the authors are not able to make recommendations for clinical practice regarding PRP for knee osteoarthritis.