ABSTRACT
Dupuytren's disease (DD) is a prevalent fibroproliferative disorder of the hand, shaped by genetic, epigenetic, and environmental influences. The extracellular matrix (ECM) is a complex assembly of diverse macromolecules. Alterations in the ECM's content, structure and organization can impact both normal physiological functions and pathological conditions. This study explored the content and organization of glycosaminoglycans, proteoglycans, and collagen in the ECM of patients at various stages of DD, assessing their potential as prognostic indicators. This research reveals, for the first time, relevant changes in the complexity of chondroitin/dermatan sulfate structures, specifically an increase of disaccharides containing iduronic acid residues covalently linked to either N-acetylgalactosamine 6-O-sulfated or N-acetylgalactosamine 4-O-sulfated, correlating with the disease's severity. Additionally, we noted an increase in versican expression, a high molecular weight proteoglycan, across stages I to IV, while decorin, a small leucine-rich proteoglycan, significantly diminishes as DD progresses, both confirmed by mRNA analysis and protein detection via confocal microscopy. Coherent anti-Stokes Raman scattering (CARS) microscopy further demonstrated that collagen fibril architecture in DD varies importantly with disease stages. Moreover, the urinary excretion of both hyaluronic and sulfated glycosaminoglycans markedly decreased among DD patients.Our findings indicate that specific proteoglycans with galactosaminoglycan chains and collagen arrangements could serve as biomarkers for DD progression. The reduction in glycosaminoglycan excretion suggests a systemic manifestation of the disease.
Subject(s)
Collagen , Decorin , Dupuytren Contracture , Proteoglycans , Humans , Dupuytren Contracture/metabolism , Dupuytren Contracture/pathology , Collagen/metabolism , Proteoglycans/metabolism , Decorin/metabolism , Extracellular Matrix/metabolism , Male , Disease Progression , Female , Dermatan Sulfate/metabolism , Middle Aged , Aged , Versicans/metabolism , Versicans/genetics , Glycosaminoglycans/metabolism , Chondroitin Sulfates/metabolism , PolysaccharidesABSTRACT
PURPOSE: To biomechanically evaluate MPTL reconstruction and compare it with two techniques for MPFL reconstruction in regard to changes in patellofemoral contact pressures and restoration of patellar stability. METHODS: This is an experimental laboratory study in eight human cadaveric knees. None had patellofemoral cartilage lesions or trochlear dysplasia as evaluated by conventional radiographs and MRI examinations. The specimens were secured in a testing apparatus, and the quadriceps was tensioned in line with the femoral shaft. Contact pressures were measured using the TekScan sensor at 30°, 60° and 90°. The sensor was placed in the patellofemoral joint through a proximal approach between femoral shaft and quadriceps tendon to not violate the medial and lateral patellofemoral complex. TekScan data were analysed to determine mean contact pressures on the medial and lateral patellar facets. Patellar lateral displacement was evaluated with the knee positioned at 30° of flexion and 9 N of quadriceps load, then a lateral force of 22 N was applied. The same protocol was used for each condition: native, medial patellofemoral complex lesion, medial patellofemoral ligament reconstruction (MPFL-R) using gracilis tendon, MPFL-R using quadriceps tendon transfer, and medial patellotibial ligament reconstruction (MPTL-R) using patellar tendon transfer. RESULTS: No statistical differences were found for mean and peak contact pressures, medial or lateral, among all three techniques. However, while both techniques of MPFL-R were able to restore the medial restraint, MPTL-R failed to restore resistance to lateral patellar translation to the native state (mean lateralization of the patella [mm]: native: 9.4; lesion: 22; gracilis MPFL-R: 8.1; quadriceps MPFL-R: 11.3; MPTL-R: 23.4 (p < 0.001). CONCLUSION: MPTL-R and both techniques for MPFL-R did not increase patellofemoral contact pressures; however, MPTL-R failed to provide a sufficient restraint against lateral patellar translation lateral translation in 30° of flexion. It, therefore, cannot be recommended as an isolated procedure for the treatment of patellar instability.
Subject(s)
Joint Instability/surgery , Ligaments, Articular/surgery , Patellofemoral Joint/surgery , Plastic Surgery Procedures/methods , Biomechanical Phenomena , Cadaver , Female , Femur/surgery , Gracilis Muscle/surgery , Humans , Knee Joint/surgery , Ligaments, Articular/physiopathology , Male , Middle Aged , Patella/physiopathology , Patella/surgery , Patellar Dislocation/surgery , Patellar Ligament/surgery , Patellofemoral Joint/physiopathology , Quadriceps Muscle/surgery , Range of Motion, Articular , Tendon Transfer , Tendons/surgeryABSTRACT
BACKGROUND: Supracondylar fractures of the humerus are common in children. Whether fixation should be performed with crossed or lateral wires remains controversial. We performed a meta-analysis of randomized controlled trials to evaluate both techniques in terms of the function of the elbow and the risk of neurologic injury and loss of reduction. We also assessed the quality of the evidence currently available. METHODS: The MEDLINE, Embase, Cochrane Library, and LILACS (Latin American and Caribbean Health Sciences Literature) databases, as well as ongoing clinical trial databases, were searched until March 2020. The main outcomes were function, measured by the Flynn criteria, and complications (neurologic lesions and loss of reduction). A meta-analysis was conducted using relative risk (RR) analysis for dichotomous variables and difference in means for continuous variables. Heterogeneity was tested using the I2 statistic. RESULTS: Twelve trials, with a total of 930 patients, met the inclusion criteria. Both groups (crossed-wire and lateral-wire fixation) presented satisfactory functional results, with no difference between them (RR, 0.99; 95% confidence interval [CI], 0.96-1.02; P = .44). Patients undergoing crossed-wire fixation had a higher risk of iatrogenic neurologic injury (RR, 0.45; 95% CI, 0.21-0.99; P = .05). The crossed group showed greater fixation stability, with a lower incidence of loss of fracture reduction (RR, 1.39; 95% CI, 1.04-1.85; P = .03). The GRADEpro GDT (Guideline Development Tool) showed that the quality of evidence of the evaluated outcomes was low or very low. CONCLUSION: There is evidence of very low quality that fixation with lateral wires is safer regarding iatrogenic nerve lesions whereas fixation with crossed wires is more effective at maintaining fracture reduction.
Subject(s)
Humeral Fractures , Bone Wires , Child , Fracture Fixation, Internal , Humans , Humeral Fractures/surgery , Humerus , Randomized Controlled Trials as Topic , Treatment OutcomeABSTRACT
BACKGROUND: Scaffolds have considerably advanced in recent years. In orthopaedic surgery, scaffolds have been used as grafts in procedures involving tendon and ligament reconstruction. This paper aimed to produce and evaluate decellularized tendon scaffolds (DTSs) from biomechanical, microscopic, macroscopic and in vivo perspectives. METHODS: Bilateral gastrocnemius muscle tendons from 18 adult New Zealand rabbits were collected. Of these 36 tendons, 11 were used as controls (Group A - control), and 25 were used in the decellularization protocol (Group B - DTS). The groups were subjected to histological, biomechanical and macroscopic analyses, and Group B - DTS was subjected to an additional in vivo evaluation. In the decellularization protocol, we used a combination of aprotinin, ethylenediamine tetraacetic acid (EDTA), sodium dodecyl sulfate (SDS) and t-octyl-phenoxypolyethoxyethanol (Triton X-100) for six days. During this period, the scaffolds were kept at room temperature on an orbital shaker with constant motion. RESULTS: The DTSs showed an increased cross-sectional area and inter-fascicular distance and no change in parallelism or matrix organization. The nuclear material was not organized in the DTSs as it was in the control. In the biomechanical analysis, no significant differences were found between the groups after analysing the ultimate tensile load, stiffness, and elongation at the ultimate tensile load. During the in vivo evaluation, mononuclear cell infiltration was noted. CONCLUSIONS: The evaluated decellularization protocol generated a tendon scaffold, maintained the most important biomechanical characteristics and permitted cell infiltration.
Subject(s)
Orthopedic Procedures , Rotator Cuff Injuries , Animals , Biomechanical Phenomena , Extracellular Matrix , Rabbits , Rotator Cuff/surgery , Rotator Cuff Injuries/surgery , Tendons , Tissue Engineering , Tissue ScaffoldsABSTRACT
PURPOSE: To evaluate the influence of trochlear dysplasia on clinical outcomes after autologous chondrocyte implantation (ACI) for the treatment of large cartilage lesions in the patellofemoral joint (PFJ) with a minimum of 2 years' follow-up. METHODS: We performed a retrospective review of prospectively collected data of all patients submitted to cartilage repair with ACI for focal cartilage defects in the PFJ by a single surgeon. Patient factors, lesion morphology, and preoperative and postoperative patient-reported outcome measures including the Knee Injury and Osteoarthritis Score, Lysholm score, Tegner activity level, and International Knee Documentation Committee Subjective Knee Evaluation Form score were collected. Two independent observers assessed preoperative imaging to determine the presence and grade of trochlear dysplasia. Patients were stratified into 2 groups based on the presence or absence of trochlear dysplasia. Patients without trochlear dysplasia served as controls. Patients were matched 1:1 for sex, age, body mass index, lesion size, and location. RESULTS: Forty-six patients who underwent ACI in the PFJ with a mean follow-up period of 3.7 ± 1.9 years (range, 2-9 years) were enrolled in this study (23 in the trochlear dysplasia group vs 23 in the normal trochlea group). The patients' mean age was 30.1 ± 8.8 years. Patient-reported outcome measures at final follow-up did not differ between the 2 groups (P > .05). No difference in failure rates was seen between the 2 groups (n = 1 [4.3%] vs n = 1 [4.3%], P > .999). Additionally, no difference in clinical outcomes was seen between patients with high-grade dysplasia (19 patients; Dejour types B-D) and patients without dysplasia (19 patients) (P > .05). CONCLUSIONS: ACI in the PFJ provides favorable outcomes even in patients with trochlear dysplasia, which are comparable to those in patients with normal trochlear anatomy. Thus, trochlear dysplasia seems to not influence the clinical outcomes of ACI in the PFJ. LEVEL OF EVIDENCE: Level III, retrospective comparative trial.
Subject(s)
Cartilage Diseases/surgery , Cartilage, Articular/injuries , Cartilage, Articular/surgery , Chondrocytes/transplantation , Patellofemoral Joint/injuries , Patellofemoral Joint/surgery , Adult , Female , Humans , Knee Injuries/surgery , Knee Joint/surgery , Male , Middle Aged , Orthopedic Procedures/methods , Retrospective Studies , Transplantation, Autologous/methods , Young AdultABSTRACT
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.
Subject(s)
Bandages , Clavicle/injuries , Conservative Treatment/methods , Fracture Fixation/methods , Fractures, Bone/therapy , Splints , Adolescent , Adult , Aged , Fracture Fixation/adverse effects , Fracture Fixation/instrumentation , Fractures, Bone/surgery , Humans , Middle Aged , Pain Measurement , Quality of Life , Randomized Controlled Trials as Topic , Treatment OutcomeABSTRACT
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.
ABSTRACT
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.
Subject(s)
Trigger Finger Disorder/surgery , Adult , Aged , Aged, 80 and over , Female , Humans , Hyaluronic Acid/administration & dosage , Injections, Intra-Articular/adverse effects , Male , Middle Aged , Pain, Postoperative/etiology , Recurrence , Steroids/administration & dosage , Treatment Outcome , Trigger Finger Disorder/drug therapyABSTRACT
BACKGROUND: The aim of this study was to evaluate the effectiveness of two diagnostic tests routinely used for diagnosing carpal tunnel syndrome (CTS)-ultrasonography (US) and nerve conduction studies (NCS)-by comparing their accuracy based on surgical results, with the remission of paresthesia as the reference standard. METHODS: We enrolled 115 patients, all of the female gender with a high probability of a clinical diagnosis of CTS. All patients underwent US and NCS for a diagnosis and subsequent surgical treatment. As a primary outcome, the accuracy of the US and NCS diagnoses was measured by comparing their diagnoses compared with those determined by the surgical outcomes. Their accuracy was secondarily evaluated based on before and after scores of the Boston Carpal Tunnel Questionnaire (BCTQ). RESULTS: Overall, 104 patients (90.4%) were diagnosed with CTS by the surgical reference standard, 97 (84.3%) by NCS, and 90 (78.3%) by US. The concordance of NCS and surgical treatment (p < 0.001; kappa = 0.648) was superior to that of US and surgical treatment (p < 0.001; kappa = 0.423). The sensitivity and specificity of US and NCS were similar (p = 1.000 and p = 0.152, respectively: McNemar's test). The BCTQ scores were lower after surgery in patients diagnosed by both US and NCS (p < 0.001and p < 0.001, respectively: analysis of variance). CONCLUSIONS: US and NCS effectively diagnosed CTS with good sensitivity but were not effective enough to rule out a suspicion of CTS. TRIAL REGISTRATION: This study was registered at September, 10 th, 2015, and the registration number was NCT02553811 .
Subject(s)
Carpal Tunnel Syndrome/diagnostic imaging , Diagnostic Techniques, Neurological/statistics & numerical data , Adult , Aged , Carpal Tunnel Syndrome/surgery , Female , Humans , Longitudinal Studies , Middle Aged , Neural Conduction , Prospective Studies , Recovery of Function , UltrasonographyABSTRACT
BACKGROUND: A variety of cast options are available for the non-surgical treatment of distal radius fractures (DRF) in adults. However, the literature is inconclusive regarding the need to immobilize the elbow joint after reduction in order to prevent rotation of the forearm in order to maintain the reduction of DRF. This study aimed to evaluate the best method of immobilization between above-elbow (AE) and below-elbow (BE) cast groups at the end of six-month follow-up. METHODS: This is a randomized clinical trial with parallel groups and a blinded evaluator. There are two non-surgical interventions: AE and BE. Patients will be randomly assigned. A hundred twenty eight consecutive adult patients with acute (up to 7 days) displaced DRF of type A2, A3, C1, C2 or C3 by the Arbeitsgemeinschaft für Osteosynthesefragen (AO) classification will be included. The primary outcome will be the maintenance of reduction by evaluation of radiographic parameters and Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH). Secondary outcomes include function measured by Patient Rated Wrist Evaluation (PRWE), pain measured by the Visual Analogue Scale (VAS), objective functional evaluation (goniometry and dynamometry) and rate of complications. Evaluations will be performed at 1, 2, 3, 4, 6, 8, 12 and 24 weeks. For the Student's t-test, a difference of 10 points in DASH score, with 95% confidence interval, a statistical power of 95%, and 20% sampling error. We consider an extra 10% for balancing follow up losses results in 64 patients per group. DISCUSSION: Results from this study protocol will help to define the need for elbow immobilization in maintenance of reduction, as well as functional performance of below elbow cast versus above elbow cast immobilization during the immobilization period. TRIAL REGISTRATION: NCT03126175 ( http://clinicaltrials.gov ). April 24, 2017.
Subject(s)
Casts, Surgical , Fracture Fixation/methods , Radius Fractures/therapy , Wrist Injuries/therapy , Conservative Treatment , HumansABSTRACT
INTRODUCTION: Intervertebral disks have been associated with low back pain, and many therapies have been proposed for its treatment. The cellular and molecular knowledge of intervertebral disks composition and precise methods to quantify disk components are important for any type of proposed therapy. Thus, the aim of this study was to correlate glycosaminoglycans presence with the quantitation of cells, ions and collagen fiber distributions in different intervertebral disk sections. METHODS: In total, 14 intervertebral disks were used from cattle. All of the disks were dehydrated, separated in seven sections and digested in sodium-free papain buffer. Glycosaminoglycan measurements were performed in the samples according to agarose electrophoresis method; total cells were measured using the PicoGreen® technique, ions were quantified, and collagen fiber birefringence was analyzed with polarized light. RESULTS: Cations Na+ and K+ are more concentrate in the nucleus (Na(+) = 1688.50 ± 110 mmol/L; K(+) = 111.9 ± 28 mmol/L) of intervertebral disks than the annulus (Na(+) = 652.80 ± 75 mmol/L; K(+) = 55.6 ± 8 mmol/L). A negative correlation between cells number and sodium/potassium was observed (p < 0.001) Additionally, thin collagen fibers were largest in the nucleus, similar to hyaluronate distribution. CONCLUSIONS: The results suggest that annulus fibrosus cells are also sensitive to changes in ionic concentrations such as nucleus pulposus cells. Additionally, hyaluronate is related to thin collagen fibers type II.
Subject(s)
Cations/metabolism , Glycosaminoglycans/metabolism , Intervertebral Disc/metabolism , Animals , Cattle , Chondroitin Sulfates/metabolism , Collagen/metabolism , Hyaluronic Acid/metabolism , Potassium/metabolism , Sodium/metabolismABSTRACT
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.
Subject(s)
Bandages/adverse effects , Clavicle/injuries , Conservative Treatment/methods , Fractures, Bone/therapy , Immobilization/methods , Ultrasonic Therapy/methods , Adolescent , Adult , Aged , Aged, 80 and over , Conservative Treatment/adverse effects , Humans , Middle Aged , Pain Measurement , Randomized Controlled Trials as Topic , Young AdultABSTRACT
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.
Subject(s)
Absorbable Implants , Anterior Cruciate Ligament Injuries , Anterior Cruciate Ligament Reconstruction/methods , Bone Screws , Tendons/transplantation , Absorbable Implants/adverse effects , Anterior Cruciate Ligament Reconstruction/instrumentation , Bone Screws/adverse effects , Humans , Joint Instability/etiology , Knee Joint , Metals/adverse effects , Patellar Ligament/transplantation , Randomized Controlled Trials as Topic , Range of Motion, Articular , Treatment OutcomeABSTRACT
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.
Subject(s)
Clavicle/injuries , Fracture Fixation/methods , Fractures, Bone/surgery , Adult , Bone Plates , Clavicle/surgery , Female , Fracture Fixation, Intramedullary/methods , Fractures, Ununited/surgery , Humans , Male , Middle Aged , Randomized Controlled Trials as Topic , Treatment FailureABSTRACT
BACKGROUND: Core myopathies are a clinically and genetically heterogeneous group of congenital myopathies with the common defined histopathological feature of focally reduced oxidative activity on muscle biopsy. It has a low incidence, however, recent articles show broad clinical spectrum, suggesting that the real incidence should be considerably larger than previously described. Due to the important association between scoliosis and paravertebral muscle imbalance, numerous authors study, by biopsy of the spinal rotator muscles, potential changes that may elucidate the etiology of adolescent idiopathic scoliosis. CASE PRESENTATION: Two patients have been followed at Spine Group of Department of Orthopedics at Federal University of São Paulo, with an initial diagnosis of idiopathic scoliosis. Both patients had clinical and radiological findings compatible with it. The patients authorized, through the Term of Consent, intraoperative biopsy of muscle multifidus from the apex of the thoracic curve on concave and convex sides. After muscle biopsy was performed a histopathological analysis. As regard to the histopathological features: in both patients were identified, the presence of core structures in extensive areas with reduced oxidative activity running along the muscle fiber. CONCLUSIONS: All patients with 'idiopathic' scoliosis deserve a careful neurological evaluation, even if they have minimal muscle symptoms in the extremities. The frequent occurrence of scoliosis in patients with CORE Myopathies, supports the thesis that the change in the paravertebral muscle fiber must be the underlying pathogenic factor in scoliosis and may help us understand the onset and progression of curves in patients previously diagnosed with idiopathic scoliosis.
Subject(s)
Muscle Weakness , Muscular Diseases/diagnosis , Scoliosis/diagnosis , Adolescent , Diagnosis, Differential , Female , Humans , Muscular Diseases/complications , Scoliosis/complicationsABSTRACT
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.
Subject(s)
Bandages/adverse effects , Clavicle/injuries , Fractures, Bone/therapy , Ultrasonic Therapy/methods , Adolescent , Adult , Aged , Aged, 80 and over , Humans , Immobilization/methods , Middle Aged , Pain Measurement , Randomized Controlled Trials as Topic , Young AdultABSTRACT
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.
Subject(s)
Platelet Transfusion/methods , Platelet-Rich Plasma , Soft Tissue Injuries/therapy , Achilles Tendon/injuries , Anterior Cruciate Ligament Reconstruction , Blood Transfusion, Autologous , Female , Humans , Male , Randomized Controlled Trials as Topic , Rotator Cuff Injuries , Shoulder Impingement Syndrome/therapy , Tendinopathy/therapy , Tennis Elbow/therapyABSTRACT
BACKGROUND: Various treatments are available for reducible unstable fractures of the distal radius, such as closed reduction combined with fixation by external fixator (EF), and rigid internal fixation using a locked volar plate (VP). Although there are studies comparing these methods, there is no conclusive evidence indicating which treatment is best. The hypothesis of this study is that surgical treatment with a VP is more effective than EF from the standpoint of functional outcome (patient-reported). METHODS/DESIGN: The study is randomized clinical trial with parallel groups and a blinded evaluator and involves the surgical interventions EF and VP. Patients will be randomly assigned (assignment ratio 1:1) using sealed opaque envelopes. This trial will include consecutive adult patients with an acute (up to 15 days) displaced, unstable fracture of the distal end of the radius of type A2, A3, C1, C2 or C3 by the Arbeitsgemeinschaft für Osteosynthesefragen-Association for the Study of Internal Fixation classification and type II or type III by the IDEAL32 classification, without previous surgical treatments of the wrist. The surgical intervention assigned will be performed by three surgical specialists familiar with the techniques described. Evaluations will be performed at 2, and 8 weeks, 3, 6 and 12 months, with the primary outcomes being measured by the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire and measurement of pain (Visual Analog Pain Scale and digital algometer). Secondary outcomes will include radiographic parameters, objective functional evaluation (goniometry and dynamometry), and the rate of complications and method failure according to the intention-to-treat principle. Final postoperative evaluations (6 and 12 months) will be performed by independent blinded evaluators. For the Student's t-test, a difference of 10 points in the DASH score, with a 95% confidence interval, a statistical power of 80%, and 20% sampling error results in 36 patients per group. DISCUSSION: Results from this study protocol will improve the current evidence regarding to the surgical treatment these fractures. TRIAL REGISTRATION: ISCRTN09599740.
Subject(s)
Bone Plates , External Fixators , Fracture Fixation/methods , Radius Fractures/surgery , Adult , Clinical Protocols , Female , Follow-Up Studies , Fracture Fixation/instrumentation , Fracture Fixation, Internal , Humans , Male , Patient Selection , Radiography , Radius Fractures/diagnostic imaging , Recovery of Function , Severity of Illness Index , Single-Blind Method , Visual Analog ScaleABSTRACT
BACKGROUND: In nerve injury with nervous gap, no restitution method was found better than the autograft, however, it has the disadvantage of damaging a normal nerve to be used as a graft. Platelet-rich plasma (PRP) is a possible filler material for vein grafts used as conduits for nerve regeneration, preventing its collapse, and providing growth factors and osteoconductive proteins. METHODS: Isogenic rats were randomly divided into three groups. They received nerve autografts (GRF), PRP-containing vein grafts or a sham operation. Outcomes were evaluated by the sciatic functional index (SFI), morphometric, and morphologic analyses of the nerve distal to the lesion, and the number of spinal cord motoneurons positive for retrograde Fluoro-Gold (Santa Cruz Biotechnology, Inc., Dallas, TX) tracer. RESULTS: The PRP and GRF groups had lower SFI values than the control animals throughout the postoperative period. The SFI was significantly higher in the PRP group than the GRF group at 90 days postoperatively (p = 0.011). Fiber diameter and number of motoneurons were significantly decreased in both the PRP and GRF groups, as compared with the control. CONCLUSION: PRP within a vein conduit may be an effective alternative or adjuvant to GRF, the current preferred treatment for nerve injury with a nerve gap, and further investigations are required to fully define the role of PRP in nerve regeneration.
Subject(s)
Nerve Regeneration , Peripheral Nerve Injuries/physiopathology , Veins/transplantation , Animals , Autografts , Male , Platelet-Rich Plasma , Rats, Inbred SHRABSTRACT
Objective: To evaluate the usefulness of the Phalen test and the Tinel sign in the prognosis and the impact on quality of life in the clinical course of patients with carpal tunnel syndrome undergoing surgical treatment through the traditional open approach. Methods: The present is a cohort study on prognosis. We included 115 patients with high probability of receiving a clinical diagnosis of carpal tunnel syndrome with indication for surgical treatment. All patients underwent the Phalen test and Tinel sign and answered the Boston Carpal Tunnel Questionnaire before and after the surgical treatment. Results: The estimates for the probability of the time until remission of the Phalen test at 2, 4 and 16 weeks postoperatively were of 3.54% (95% confidence interval [95%CI]: 1.16%-8.17%), 0.88% (95%CI: 0.08%-4.38%) and 0.88% (95%CI: 0.08% to 4.38%) respectively, and, for the Tinel sign, they were of 12.39% (95%CI: 7.13%-19.18% ), 4.42% (95%CI : 1.65%-9.36%) and 2.65% (95%CI : 0.70%-6.94%) respectively. There was a reduction in the postoperative score on the Boston Carpal Tunnel Questionnaire of 1.8 points for symptom severity ( p < 0.001) and of 1.6 points for functional status ( p < 0.001). Conclusion: Phalen test remission was earlier than that of the Tinel sign, but, when performed as of the second postoperative week, they were prognostic factors favorable to the clinical course, with improved quality of life.