Participant recruitment and attrition in surgical randomised trials with placebo controls versus non-operative controls: a meta-epidemiological study and meta-analysis.

OBJECTIVE: To compare differences in recruitment and attrition between placebo control randomised trials of surgery, and trials of the same surgical interventions and conditions that used non-operative (non-placebo) controls. DESIGN: Meta-epidemiological study. DATA SOURCES: Randomised controlled trials were identified from an electronic search of MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials from their inception date to 21 November 2018. STUDY SELECTION: Placebo control trials evaluating efficacy of any surgical intervention and non-operative control trials of the same surgical intervention were included in this study. 25 730 records were retrieved from our systemic search, identifying 61 placebo control and 38 non-operative control trials for inclusion in analysis. OUTCOME MEASURES: Primary outcome measures were recruitment and attrition. These were assessed in terms of recruitment rate (number of participants enrolled, as a proportion of those eligible) and overall attrition rate (composite of dropout, loss to follow-up and cross-overs, expressed as proportion of total sample size). Secondary outcome measures included participant cross-over rate, dropout and loss to follow-up. RESULTS: Unadjusted pooled recruitment and attrition rates were similar between placebo and non-operative control trials. Study characteristics were not significantly different apart from time to primary timepoint which was shorter in studies with placebo controls (365 vs 274 days, p=0.006). After adjusting for covariates (follow-up duration and number of timepoints), the attrition rate of placebo control trials was almost twice as high compared with non-operative controlled-trials (incident rate ratio (IRR) (95% CI) 1.8 (1.1 to 3.0), p=0.032). The incorporation of one additional follow-up timepoint (regardless of follow-up duration) was associated with reduced attrition in placebo control surgical trials (IRR (95% CI) 0.64 (0.52 to 0.79), p<0.001). CONCLUSIONS: Placebo control trials of surgery have similar recruitment issues but higher attrition compared with non-operative (non-placebo) control trials. Study design should incorporate strategies such as increased timepoints for given follow-up duration to mitigate losses to follow-up and dropout. PROSPERO REGISTRATION NUMBER: CRD42019117364.

Surgery, Needle Fasciotomy, or Collagenase Injection for Dupuytren Contracture : A Randomized Controlled Trial.

BACKGROUND: Surgery, needle fasciotomy, and collagenase injection are used to treat Dupuytren contracture. The treatment decision requires balancing initial morbidity and costs of surgery against its potential long-term benefits over needle fasciotomy and collagenase. OBJECTIVE: To compare the effectiveness of surgery, needle fasciotomy, and collagenase injection at 3 months and 2 years (secondary time points of the trial). DESIGN: A multicenter, randomized, outcome assessor-blinded, superiority trial. (ClinicalTrials.gov: NCT03192020). SETTING: 6 public hospitals in Finland. PARTICIPANTS: 302 persons with treatment-naive Dupuytren contracture (contracture angle <135°). INTERVENTION: Surgery (n = 101), needle fasciotomy (n = 101), or collagenase (n = 100). MEASUREMENTS: The primary outcome was the success rate, defined as greater than 50% contracture release and patients reaching the patient acceptable symptom state. Secondary outcomes included hand function, pain, quality of life, patient satisfaction, residual contracture angle, finger flexion, risk for retreatment, and serious adverse events. RESULTS: A total of 292 (97%) and 284 (94%) participants completed the 3-month and 2-year follow-ups. Success rates were similar at 3 months: 71% (95% CI, 62% to 80%) for surgery, 73% (CI, 64% to 82%) for needle fasciotomy, and 73% (CI, 64% to 82%) for collagenase. At 2 years, surgery had superior success rates compared with both needle fasciotomy (78% vs. 50%; adjusted risk difference [aRD], 0.30 [CI, 0.17 to 0.43]) and collagenase (78% vs. 65%; aRD, 0.13 [CI, 0.01 to 0.26]). Secondary analyses paralleled with the primary analysis. LIMITATION: Participants were not blinded. CONCLUSION: Initial outcomes are similar between the treatments, but at 2 years success rates were maintained in the surgery group but were lower with both needle fasciotomy and collagenase despite retreatments. PRIMARY FUNDING SOURCE: Research Council of Finland.

Surgical versus non-surgical treatment for carpal tunnel syndrome.

BACKGROUND: Carpal tunnel syndrome (CTS) is a compression neuropathy of the median nerve at the wrist. Surgery is considered when symptoms persist despite the use of non-surgical treatments. It is unclear whether surgery produces a better outcome than non-surgical therapy. This is an update of a Cochrane review published in 2008. OBJECTIVES: To assess the evidence regarding the benefits and harms of carpal tunnel release compared with non-surgical treatment in the short (< 3 months) and long (> 3 months) term. SEARCH METHODS: In this update, we included studies from the previous version of this review and searched the Cochrane Neuromuscular Specialised Register, CENTRAL, Embase, MEDLINE, ClinicalTrials.gov and WHO ICTRP until 18 November 2022. We also checked the reference lists of included studies and relevant systematic reviews for studies. SELECTION CRITERIA: We included randomised controlled trials comparing any surgical technique with any non-surgical therapies for CTS. DATA COLLECTION AND ANALYSIS: We used the standard methodological procedures expected by Cochrane. MAIN RESULTS: The 14 included studies randomised 1231 participants (1293 wrists). Eighty-four per cent of participants were women. The mean age ranged from 32 to 53 years, and the mean duration of symptoms from 31 weeks to 3.5 years. Trial sizes varied from 22 to 176 participants. The studies compared surgery with: splinting, corticosteroid injection, splinting and corticosteroid injection, platelet-rich plasma injection, manual therapy, multimodal non-operative treatment, unspecified medical treatment and hand support, and surgery and corticosteroid injection with corticosteroid injection alone. Since surgery is generally used for its long-term effects, this abstract presents only long-term results for surgery versus splinting and surgery versus corticosteroid injection. 1) Surgery compared to splinting in the long term (> 3 months) Surgery probably results in a higher rate of clinical improvement (risk ratio (RR) 2.10, 95% confidence interval (CI) 1.04 to 4.24; 3 studies, 210 participants; moderate-certainty evidence). Surgery probably does not provide clinically important benefit in symptoms or hand function compared with splinting (moderate-certainty evidence). The mean Boston Carpal Tunnel Questionnaire (BCTQ) Symptom Severity Scale (scale 1 to 5; higher is worse; minimal clinically important difference (MCID) = 1) was 1.54 with splint and 0.26 points better with surgery (95% CI 0.52 better to 0.01 worse; 2 studies, 195 participants). The mean BCTQ Functional Status Scale (scale 1 to 5; higher is worse; MCID 0.7) was 1.75 with splint and 0.36 points better with surgery (95% CI 0.62 better to 0.09 better; 2 studies, 195 participants). None of the studies reported pain. Surgery may not provide better health-related quality of life compared with splinting (low-certainty evidence). The mean EQ-5D index (scale 0 to 1; higher is better; MCID 0.074) was 0.81 with splinting and 0.04 points better with surgery (95% CI 0.0 to 0.08 better; 1 study, 167 participants). We are uncertain about the risk of adverse effects (very low-certainty evidence). Adverse effects were reported amongst 60 of 98 participants (61%) in the surgery group and 46 of 112 participants (41%) in the splinting group (RR 2.11, 95% CI 0.37 to 12.12; 2 studies, 210 participants). Surgery probably reduces the risk of further surgery; 41 of 93 participants (44%) were referred to surgery in the splinting group and 0 of 83 participants (0%) repeated surgery in the surgery group (RR 0.03, 95% CI 0.00 to 0.21; 2 studies, 176 participants). This corresponds to a number needed to treat for an additional beneficial outcome (NNTB) of 2 (95% CI 1 to 9). 2) Surgery compared to corticosteroid injection in the long term (> 3 months) We are uncertain if clinical improvement or symptom relief differs between surgery and corticosteroid injection (very low-certainty evidence). The RR for clinical improvement was 1.23 (95% CI 0.73 to 2.06; 3 studies, 187 participants). For symptoms, the standardised mean difference (SMD) was -0.60 (95% CI -1.88 to 0.69; 2 studies, 118 participants). This translates to 0.4 points better (95% CI from 1.3 better to 0.5 worse) on the BCTQ Symptom Severity Scale. Hand function or pain probably do not differ between surgery and corticosteroid injection (moderate-certainty evidence). For function, the SMD was -0.12 (95% CI -0.80 to 0.56; 2 studies, 191 participants) translating to 0.10 points better (95% CI 0.66 better to 0.46 worse) on the BCTQ Functional Status Scale with surgery. Pain (0 to 100 scale) was 8 points with corticosteroid injection and 6 points better (95% CI 10.45 better to 1.55 better; 1 study, 123 participants) with surgery. We found no data to estimate the difference in health-related quality of life (very low-certainty evidence). We are uncertain about the risk of adverse effects and further surgery (very low-certainty evidence). Adverse effects were reported amongst 3 of 45 participants (7%) in the surgery group and 2 of 45 participants (4%) in the corticosteroid injection group (RR 1.49, 95% CI 0.25 to 8.70; 2 studies, 90 participants). In one study, 12 of 83 participants (15%) needed surgery in the corticosteroid group, and 7 of 80 participants (9%) needed repeated surgery in the surgery group (RR 0.61, 95% CI 0.25 to 1.46; 1 study, 163 participants). AUTHORS' CONCLUSIONS: Currently, the efficacy of surgery in people with CTS is unclear. It is also unclear if the results can be applied to people who are not satisfied after trying various non-surgical options. Future studies should preferably blind participants from treatment allocation and randomise people who are dissatisfied after being treated non-surgically. The decision for a patient to opt for surgery should balance the small benefits and potential risks of surgery. Patients with severe symptoms, a high preference for clinical improvement and reluctance to adhere to non-surgical options, and who do not consider potential surgical risks and morbidity a burden, may choose surgery. On the other hand, those who have tolerable symptoms, who have not tried non-surgical options and who want to avoid surgery-related morbidity can start with non-surgical options and have surgery only if necessary. We are uncertain if the risk of adverse effects differs between surgery and non-surgical treatments. The severity of adverse effects may also be different.

Proximal ROw carpectOmy versus four-corner Fusion (PROOF-trial) for osteoarthritis of the wrist: study protocol for multi-institutional double-blinded randomized controlled trial.

BACKGROUND: Scapholunate advanced collapse (SLAC) and scaphoid non-union advanced collapse (SNAC) are common types of wrist osteoarthritis (OA). Non-operative treatment consists of pain medication, splinting, and avoiding activities that induce pain. However, in case a course of conservative treatment is unsuccessful, operative treatment is needed. The two most conventional operative approaches for SLAC/SNAC OA are four-corner arthrodesis (FCA) and proximal row carpectomy (PRC). Although FCA is the gold-standard operative technique and may lead to superior grip strength, the evident benefit of PRC is that it obviates any need for hardware removal and controlling for bony union. To date, no high-quality randomized controlled trial comparing FCA and PRC exists. As clinical outcomes seem comparable, a trial that assesses patient-reported outcomes, adverse events, and secondary operations may guide clinical decision making between these two procedures. Thus, the aim of this multi-institutional double-blind randomized controlled trial is to study whether PRC is non-inferior to FCA in treating SLAC/SNAC OA. We hypothesize that PRC is non-inferior to FCA with lower economic expanses. METHODS: The trial is designed as a randomized, controlled, patient- and outcome-assessor blinded multicenter, two-armed 1:1 non-inferiority trial. Patients with SLAC/SNAC-induced wrist pain meeting trial inclusion criteria will undergo wrist arthroscopy to further assess eligibility. Each patient eligible for the trial will be randomly assigned to undergo either FCA or PRC. The primary endpoint of this study is the Patient Rated Wrist Evaluation (PRWE) at 1-year after FCA versus PRC. Secondary outcomes include Quick-Disabilities of the Arm, Shoulder and Hand, EQ-5D-5L, pain, grip strength, wrist active range of motion, radiographic evaluation, and adverse events. Trial design, methods, and statistical analysis plan will be presented here. DISCUSSION: We present an RCT design comparing FCA vs PRC for SLAC/SNAC-induced OA. The results of this trial will assist in decision making when planning surgery for SLAC/SNAC. TRIAL REGISTRATION: ClinicalTrials.gov NCT04260165 . Registered February 7, 2020.

Minimal important difference, patient acceptable symptom state and longitudinal validity of oxford elbow score and the quickDASH in patients with tennis elbow.

BACKGROUND: The Oxford Elbow Score (OES) and the short version of Disabilities of Arms, Shoulder and Hand (QuickDASH) are common patient-reported outcomes for people with elbow problems. Our primary objective was to define thresholds for the Minimal Important Difference (MID) and Patient-Acceptable Symptom State (PASS) for the OES and QuickDASH. The secondary aim was to compare the longitudinal validity of these outcome measures. METHODS: We recruited 97 patients with clinically-diagnosed tennis elbow for a prospective observational cohort study in a pragmatic clinical setting. Fifty-five participants received no specific intervention, 14 underwent surgery (11 as primary treatment and 4 during follow-up), and 28 received either botulinum toxin injection or platelet rich plasma injection. We collected OES (0 to 100, higher is better) and QuickDASH (0 to 100, higher is worse), and global rating of change (as an external transition anchor question) at six weeks, three months, six months and 12 months. We defined MID and PASS values using three approaches. To assess the longitudinal validity of the measures, we calculated the Spearman's correlation coefficient between the change in the outcome scores and external transition anchor question, and the Area Under the Curve (AUC) from a receiver operating characteristics (ROC) analysis. To assess signal-to-noise ratio, we calculated standardized response means. RESULTS: Depending on the method, MID values ranged from 16 to 21 for OES Pain; 10 to 17 for OES Function; 14 to 28 for OES Social-psychological; 14 to 20 for OES Total score, and - 7 to -9 for QuickDASH. Patient-Acceptable Symptom State (PASS) cut offs were 74 to 84 for OES Pain; 88 to 91 for OES Function; 75 to 78 with OES Social-psychological; 80 to 81 with OES Total score and 19 to 23 with Quick-DASH. OES had stronger correlations with the anchor items, and AUC values suggested superior discrimination (between improved and not improved) compared with QuickDASH. OES also had superior signal-to-noise ratio compared with QuickDASH. CONCLUSION: The study provides MID and PASS values for OES and QuickDASH. Due to better longitudinal validity, OES may be a better choice for clinical trials. TRIAL REGISTRATION: ClinicalTrials.gov NCT02425982 (first registered April 24, 2015).

Minimal invasions: is wrist arthroscopy supported by evidence? A systematic review and meta-analysis.

BACKGROUND AND PURPOSE: Wrist arthroscopy is used increasingly, but its benefits and harms are unclear. This systematic review aimed to identify all published randomized controlled trials on wrist arthroscopy and synthesize the evidence of the benefits and harms of wrist arthroscopic procedures. METHODS: We searched CENTRAL, MEDLINE, and Embase for randomized controlled trials comparing wrist-arthroscopic surgery with corresponding open surgery, placebo surgery, a non-surgical treatment, or no treatment. We estimated the treatment effect with a random effect meta-analysis using patient reported outcome measure (PROM) as primary outcome where several studies assessed the same intervention. RESULTS: Of 7 included studies, none compared wrist arthroscopic procedures with no treatment or placebo surgery. 3 trials compared arthroscopically assisted reduction with fluoroscopic reduction of intra-articular distal radius fractures. The certainty of evidence was low to very low for all comparisons. The benefit of arthroscopy was clinically unimportant (smaller than what patients may consider meaningful) at all time points. 2 studies compared arthroscopic and open resection of wrist ganglia, finding no significant difference in recurrence rates. 1 study estimated the benefit of arthroscopic joint debridement and irrigation in intra-articular distal radius fractures, showing no clinically relevant benefit. 1 study compared arthroscopic triangular fibrocartilage complex repair with splinting in distal radioulnar joint instability in people with distal radius fractures, finding no evidence of benefits for repair at the long-term follow-up but the study was unblinded, and the estimates imprecise. CONCLUSION: The current limited evidence from RCTs does not support benefits of wrist arthroscopy compared with open or non-surgical interventions.

Splinting for carpal tunnel syndrome.

BACKGROUND: Carpal tunnel syndrome (CTS) is a compression neuropathy of the median nerve causing pain and numbness and tingling typically in the thumb, index and middle finger. It sometimes results in muscle wasting, diminished sensitivity and loss of dexterity. Splinting the wrist (with or without the hand) using an orthosis is usually offered to people with mild-to-moderate findings, but its effectiveness remains unclear. OBJECTIVES: To assess the effects (benefits and harms) of splinting for people with CTS. SEARCH METHODS: On 12 December 2021, we searched the Cochrane Neuromuscular Specialised Register, CENTRAL, MEDLINE, Embase, AMED, CINAHL, ClinicalTrials.gov, and WHO ICTRP with no limitations. We checked the reference lists of included studies and relevant systematic reviews for studies. SELECTION CRITERIA: Randomised trials were included if the effect of splinting could be isolated from other treatment modalities. The comparisons included splinting versus no active treatment (or placebo), splinting versus another disease-modifying non-surgical treatment, and comparisons of different splint-wearing regimens. We excluded studies comparing splinting with surgery or one splint design with another. We excluded participants if they had previously undergone surgical release. DATA COLLECTION AND ANALYSIS: Review authors independently selected trials for inclusion, extracted data, assessed study risk of bias and the certainty in the body of evidence for primary outcomes using the GRADE approach, according to standard Cochrane methodology. MAIN RESULTS: We included 29 trials randomising 1937 adults with CTS. The trials ranged from 21 to 234 participants, with mean ages between 42 and 60 years. The mean duration of CTS symptoms was seven weeks to five years. Eight studies with 523 hands compared splinting with no active intervention (no treatment, sham-kinesiology tape or sham-laser); 20 studies compared splinting (or splinting delivered along with another non-surgical intervention) with another non-surgical intervention; and three studies compared different splinting regimens (e.g. night-time only versus full time). Trials were generally at high risk of bias for one or more domains, including lack of blinding (all included studies) and lack of information about randomisation or allocation concealment in 23 studies. For the primary comparison, splinting compared to no active treatment, splinting may provide little or no benefits in symptoms in the short term (< 3 months). The mean Boston Carpal Tunnel Questionnaire (BCTQ) Symptom Severity Scale (SSS) (scale 1 to 5, higher is worse; minimal clinically important difference (MCID) 1 point) was 0.37 points better with splint (95% confidence interval (CI) 0.82 better to 0.08 worse; 6 studies, 306 participants; low-certainty evidence) compared with no active treatment. Removing studies with high or unclear risk of bias due to lack of randomisation or allocation concealment supported our conclusion of no important effect (mean difference (MD) 0.01 points worse with splint; 95% CI 0.20 better to 0.22 worse; 3 studies, 124 participants). In the long term (> 3 months), we are uncertain about the effect of splinting on symptoms (mean BCTQ SSS 0.64 better with splinting; 95% CI 1.2 better to 0.08 better; 2 studies, 144 participants; very low-certainty evidence). Splinting probably does not improve hand function in the short term and may not improve hand function in the long term. In the short term, the mean BCTQ Functional Status Scale (FSS) (1 to 5, higher is worse; MCID 0.7 points) was 0.24 points better (95% CI 0.44 better to 0.03 better; 6 studies, 306 participants; moderate-certainty evidence) with splinting compared with no active treatment. In the long term, the mean BCTQ FSS was 0.25 points better (95% CI 0.68 better to 0.18 worse; 1 study, 34 participants; low-certainty evidence) with splinting compared with no active treatment. Night-time splinting may result in a higher rate of overall improvement in the short term (risk ratio (RR) 3.86, 95% CI 2.29 to 6.51; 1 study, 80 participants; number needed to treat for an additional beneficial outcome (NNTB) 2, 95% CI 2 to 2; low-certainty evidence).  We are uncertain if splinting decreases referral to surgery, RR 0.47 (95% CI 0.14 to 1.58; 3 studies, 243 participants; very low-certainty evidence).  None of the trials reported health-related quality of life. Low-certainty evidence from one study suggests that splinting may have a higher rate of adverse events, which were transient, but the 95% CIs included no effect. Seven of 40 participants (18%) reported adverse effects in the splinting group and 0 of 40 participants (0%) in the no active treatment group (RR 15.0, 95% CI 0.89 to 254.13; 1 study, 80 participants).  There was low- to moderate-certainty evidence for the other comparisons: splinting may not provide additional benefits in symptoms or hand function when given together with corticosteroid injection (moderate-certainty evidence) or with rehabilitation (low-certainty evidence); nor when compared with corticosteroid (injection or oral; low certainty), exercises (low certainty), kinesiology taping (low certainty), rigid taping (low certainty), platelet-rich plasma (moderate certainty), or extracorporeal shock wave treatment (moderate certainty). Splinting for 12 weeks may not be better than six weeks, but six months of splinting may be better than six weeks of splinting in improving symptoms and function (low-certainty evidence). AUTHORS' CONCLUSIONS: There is insufficient evidence to conclude whether splinting benefits people with CTS. Limited evidence does not exclude small improvements in CTS symptoms and hand function, but they may not be clinically important, and the clinical relevance of small differences with splinting is unclear. Low-certainty evidence suggests that people may have a greater chance of experiencing overall improvement with night-time splints than no treatment. As splinting is a relatively inexpensive intervention with no plausible long-term harms, small effects could justify its use, particularly when patients are not interested in having surgery or injections. It is unclear if a splint is optimally worn full time or at night-time only and whether long-term use is better than short-term use, but low-certainty evidence suggests that the benefits may manifest in the long term.

Is it time to reconsider the indications for surgery in patients with tennis elbow?

Tennis elbow (lateral epicondylitis or lateral elbow tendinopathy) is a self-limiting condition in most patients. Surgery is often offered to patients who fail to improve with conservative treatment. However, there is no evidence to support the superiority of surgery over continued nonoperative care or no treatment. New evidence also suggests that the prognosis of tennis elbow is not influenced by the duration of symptoms, and that there is a 50% probability of recovery every three to four months. This finding challenges the belief that failed nonoperative care is an indication for surgery. In this annotation, we discuss the clinical and research implications of the benign clinical course of tennis elbow.Cite this article: Bone Joint J 2023;105-B(2):109-111.

Anterior locking plate versus non-operative treatment in different age groups with distal radial fractures: a systematic review and meta-analysis.

This meta-analysis compared anterior locking plate and non-operative treatment for distal radial fractures and assessed if the age of the patients is associated with the treatment effect. We searched the MEDLINE, Embase and CENTRAL databases and included 12 studies with 1366 patients. Compared with non-operative care, anterior locking plate treatment does not seem to provide clinically important benefits in mean DASH score, mean pain or their mean quality of life at 12 to 24 months if the patients' ages are not considered (moderate to low certainty evidence). However, the younger the patients, the larger the benefit for surgery. Meta-regression with the DASH score suggested that while people over 70 likely experience no clinically relevant benefit from surgery, the mean effects cannot be generalized to people under 60. The evidence regarding the risk of adverse events is too uncertain to make firm conclusions.

Detecting Distal Radius Fractures Using a Segmentation-Based Deep Learning Model.

Deep learning algorithms can be used to classify medical images. In distal radius fracture treatment, fracture detection and radiographic assessment of fracture displacement are critical steps. The aim of this study was to use pixel-level annotations of fractures to develop a deep learning model for precise distal radius fracture detection. We randomly divided 3785 consecutive emergency wrist radiograph examinations from six hospitals to a training set (3399 examinations) and test set (386 examinations). The training set was used to develop the deep learning model and the test set to assess its validity. The consensus of three hand surgeons was used as the gold standard for the test set. The area under the ROC curve was 0.97 (CI 0.95-0.98) and 0.95 (CI 0.92-0.98) for examinations without a cast. Fractures were identified with higher accuracy in the postero-anterior radiographs than in the lateral radiographs. Our deep learning model performed well in our multi-hospital and multi-radiograph system manufacturer settings. Thus, segmentation-based deep learning models may provide additional benefit. Further research is needed with algorithm comparison and external validation.

Clinical Outcomes After Aggressive Active Early Motion and Modified Kleinert Regimens: Comparison of 2 Consecutive Cohorts.

BACKGROUND: Modern multistrand repairs can withstand forces present in active flexion exercises, and this may improve the outcomes of flexor tendon repairs. We developed a simple home-based exercise regimen with free wrist and intrinsic minus splint aimed at facilitating the gliding of the flexor tendons and compared the outcomes with the modified Kleinert regimen used previously in the same institution. METHODS: We searched the hospital database to identify flexor tendon repair performed before and after the new regimen was implemented and invited all patients to participate. The primary outcome was total active range of motion, and secondary outcomes were Disabilities of Arm, Shoulder, and Hand; grip strength; globally perceived function; and the quality of life. RESULTS: The active range of motion was comparable between the groups (mean difference = 14; 95% confidence interval [CI], -8 to 36; P = .22). Disabilities of Arm, Shoulder, and Hand; grip strength; global perceived function; and health-related quality of life were also comparable between the groups. There was 1 (5.3%) rupture in the modified Kleinert group and 4 (15.4%) in the early active motion group (relative risk = 0.3; 95% CI, 0.04-2.5; P = .3). CONCLUSIONS: Increasing active gliding with a free wrist and intrinsic minus splint did not improve the clinical outcomes after flexor tendon injury at a mean of 38-month follow-up.

Minimal important difference and patient acceptable symptom state for common outcome instruments in patients with a closed humeral shaft fracture - analysis of the FISH randomised clinical trial data.

BACKGROUND: Two common ways of assessing the clinical relevance of treatment outcomes are the minimal important difference (MID) and the patient acceptable symptom state (PASS). The former represents the smallest change in the given outcome that makes people feel better, while the latter is the symptom level at which patients feel well. METHODS: We recruited 124 patients with a humeral shaft fracture to a randomised controlled trial comparing surgery to nonsurgical care. Outcome instruments included the Disabilities of Arm, Shoulder, and Hand (DASH) score, the Constant-Murley score, and two numerical rating scales (NRS) for pain (at rest and on activities). A reduction in DASH and pain scores, and increase in the Constant-Murley score represents improvement. We used four methods (receiver operating characteristic [ROC] curve, the mean difference of change, the mean change, and predictive modelling methods) to determine the MID, and two methods (the ROC and 75th percentile) for the PASS. As an anchor for the analyses, we assessed patients' satisfaction regarding the injured arm using a 7-item Likert-scale. RESULTS: The change in the anchor question was strongly correlated with the change in DASH, moderately correlated with the change of the Constant-Murley score and pain on activities, and poorly correlated with the change in pain at rest (Spearman's rho 0.51, -0.40, 0.36, and 0.15, respectively). Depending on the method, the MID estimates for DASH ranged from -6.7 to -11.2, pain on activities from -0.5 to -1.3, and the Constant-Murley score from 6.3 to 13.5. The ROC method provided reliable estimates for DASH (-6.7 points, Area Under Curve [AUC] 0.77), the Constant-Murley Score (7.6 points, AUC 0.71), and pain on activities (-0.5 points, AUC 0.68). The PASS estimates were 14 and 10 for DASH, 2.5 and 2 for pain on activities, and 68 and 74 for the Constant-Murley score with the ROC and 75th percentile methods, respectively. CONCLUSION: Our study provides credible estimates for the MID and PASS values of DASH, pain on activities and the Constant-Murley score, but not for pain at rest. The suggested cut-offs can be used in future studies and for assessing treatment success in patients with humeral shaft fracture. TRIAL REGISTRATION: ClinicalTrials.gov NCT01719887, first registration 01/11/2012.

LIMPER trials: immediate mobilisation versus 2-week cast immobilisation after distal radius fracture treated with volar locking plate - a study protocol for a prospective, randomised, controlled trial.

INTRODUCTION: Open reduction and internal fixation with volar locking plate has become the most common fixation method in the treatment of unstable distal radius fracture (DRF). There is, however, no consensus as to whether or for how long a wrist should be immobilised after operative treatment. To date, there have been relatively few studies that have evaluated the effect of immediate postoperative mobilisation on functional outcomes. The aim of postoperative rehabilitation is to obtain a good function and to reduce impairment, recovery time, socioeconomical costs and absence from work. Therefore, there is a need for studies that evaluate the optimal method of postoperative rehabilitation to optimise wrist function and return to work. METHODS AND ANALYSIS: This study is a prospective, randomised, controlled trial in which a total of 240 working-age patients who undergo volar plating for DRF will be randomly assigned to either an early mobilisation group or a postoperative 2-week casting group. The aim of the study will be to compare early postoperative outcomes between the study groups. The primary outcome will be patient-rated wrist evaluation at 2 months after operation. A coprimary outcome will be the total length of sick leave. Our follow-up period will be 1 year, and secondary outcomes will include pain, patient satisfaction, perceived ability to work and complications identified at different time points. We expect those patients who undergo immediate mobilisation will have at least as rapid a return to work and function as those patients who undergo postoperative immobilisation, indicating/meaning that there will be no need for postoperative casting. ETHICS AND DISSEMINATION: This study will be conducted according to the Standard Protocol Items: Recommendations for Interventional Trials statement. The Ethics committee of Tampere University Hospital has approved the protocol. Ethics committee approval number is R21111, and it is accepted on 7 September 2021. The results of this study will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT05150925.

Randomised controlled trials in hand surgery: a scoping review.

OBJECTIVES: To identify the evidence gaps that exist regarding the efficacy or effectiveness of hand surgery. SETTING: A scoping review. We systematically searched MEDLINE, Embase and CENTRAL databases to identify all hand surgical randomised controlled trials from inception to 7 November 2020. RESULTS: Of the 220 identified randomised controlled trials, none were fundamental efficacy trials, that is, compared surgery with placebo surgery. 172 (78%) trials compared the outcomes of different surgical techniques, and 143 (65%) trials were trauma related. We identified only 47 (21%) trials comparing surgery with non-operative care or injection. CONCLUSION: The evidence supporting use of surgery especially for chronic hand conditions is scarce. To determine optimal care for people with hand conditions, more resources should be aimed at placebo-controlled trials and pragmatic effectiveness trials comparing hand surgery with non-operative care. PROSPERO REGISTRATION NUMBER: CRD42019122710.

Editorial Commentary: Arthroscopic Treatment Should No Longer Be Offered to People With Subacromial Impingement.

Arthroscopic treatment should no longer be offered to people with subacromial impingement. In many people, subacromial impingement (or subacromial pain syndrome) is self-limiting and may not require any specific treatment. This is evident by the fact that almost 50% of people with new-onset shoulder pain consult their primary care doctor only once. The best-available evidence from randomized controlled trials indicates that glucocorticoid injection provides rapid, modest, short-term pain relief. Exercise therapy has also been found to provide no added benefit over glucocorticoid injection. Subacromial decompression (bursectomy and acromioplasty) for subacromial pain syndrome provides no important benefit on pain, function, or health-related quality of life. Acromioplasty does not improve the outcomes of rotator cuff repair.

Use of Placebo and Nonoperative Control Groups in Surgical Trials: A Systematic Review and Meta-analysis.

Importance: Nonspecific effects, particularly placebo effects, are thought to contribute significantly to the observed effect in surgical trials. Objective: To estimate the proportion of the observed effect of surgical treatment that is due to nonspecific effects (including the placebo effect). Data Sources: Published Cochrane reviews and updated, extended search of MEDLINE, Embase, and CENTRAL until March 2019. Study Selection: Published randomized placebo-controlled surgical trials and trials comparing the effect of the same surgical interventions with nonoperative controls (ie, no treatment, usual care, or exercise program). Data Extraction and Synthesis: Pairs of authors independently screened the search results, assessed full texts to identify eligible studies and the risk of bias of included studies, and extracted data. The proportion of all nonspecific effects was calculated as the change in the placebo control divided by the change in the active surgery and pooled in a random-effect meta-analysis. To estimate the magnitude of the placebo effect, we pooled the difference in outcome between placebo and nonoperative controls and used metaregression to estimate the association between the type of control group and the treatment effect (difference between the groups), adjusting for risk of bias, sample size, and type of outcome. Main Outcomes and Measures: Between- and within-group effect sizes expressed as Hedges g. Results: In this review, 100 trials were included comprising data from 62 trials with placebo controls (3 also included nonoperative controls), and 38 trials with nonoperative controls (32 interventions; 10 699 participants). Risk of bias across trials was comparable except for performance and detection bias, which was high in trials with nonoperative controls. The mean nonspecific effects accounted for 67% (95% CI, 61% to 73%) of the observed change after surgery; however, this varied widely between different procedures. The estimated surgical placebo effect had a standardized mean difference (SMD) of 0.13 (95% CI, -0.26 to 0.51). Trials with placebo and nonoperative controls found comparable treatment effects (SMD, -0.09 [95% CI, -0.35 to 0.18]; 15 interventions; 73 between-group effects; adjusted analysis: SMD, -0.11 [95% CI, -0.37 to 0.15]). Conclusions and Relevance: In this review, the change in health state after surgery was composed largely of nonspecific effects, but no evidence supported a large placebo effect. Placebo-controlled surgical trials may be redundant when trials with nonoperative controls consistently report no substantial association from surgery compared with nonoperative treatment.

CO2 surgical laser for treatment of stress urinary incontinence in women: a randomized controlled trial.

BACKGROUND: Stress urinary incontinence is a common condition that can be treated conservatively and/or surgically. Given the risks of surgery, developing effective nonsurgical treatment options would be beneficial. Some studies have suggested that laser therapy may improve or cure stress urinary incontinence. However, there is a lack of sham-controlled randomized controlled trials to judge treatment efficacy. OBJECTIVE: This study aimed to compare the effects of CO2 vaginal laser vs sham therapy for treating stress urinary incontinence. STUDY DESIGN: This was a multicenter, participant-blinded, sham-controlled, parallel group (1:1) superiority randomized controlled trial performed in outpatient clinics in 2 hospitals. We included women aged 18 to 80 years with objective and subjective stress urinary incontinence. Participants had undertaken or declined supervised pelvic floor muscle training. Intervention was performed using a CO2 fractionated vaginal laser. Participants underwent 3 treatments, 4 weeks apart, with increasing energy and density settings. Sham treatment was performed using an identical technique with a deactivated pedal. The primary outcome was the subjective stress urinary incontinence rate (proportion with leak with cough, sneeze, or laughter) at 3 months after completion of treatment. Secondary outcomes included objective stress urinary incontinence, change in the disease-specific patient-reported outcomes, health-related quality of life, and adverse effects. Categorical outcomes were compared using the chi square test and continuous outcomes using analysis of covariance, adjusting for the baseline score. RESULTS: There were 52 participants who received laser and 49 who received sham treatment. One participant in each group withdrew from the study before the endpoint, and 2 participants in the laser group did not participate in the follow-up visits. Participant mean age was 53 (34-79) years. Mean body mass index was 26.1 (18.1-49.6); 90% were vaginally parous. At 3 months, there was no difference between the sham and active treatment arm in subjective stress urinary incontinence (46 [96%] vs 48 [98%]; relative risk, 0.98 [95% confidence interval, 0.91-1.05]; P=.55) or in objective stress urinary incontinence (37 [80%] vs 33 [80%]; relative risk, 0.99 [95% confidence interval, 0.81-1.23]; P=.995). Patient-reported outcomes and health-related quality of life were also comparable between the groups. Vaginal bleeding occurred in 3 participants after laser and 1 participant after sham treatment. Pain during treatment did not differ between laser and sham treatment. CONCLUSION: We were unable to show an improvement in stress urinary incontinence after CO2 vaginal laser therapy compared with sham treatment.

Operative vs Nonoperative Treatment of Achilles Tendon Ruptures Using Early Functional Rehabilitation: Critical Analysis of Evidence.

BACKGROUND: Nonoperative treatment with functional rehabilitation of Achilles tendon ruptures (ATRs) has become more common because of claim of "equivalent" risk of rerupture compared to operative treatment. We investigated how current evidence corroborates the often-claimed "equal" or "nondifferent" complication rates. METHODS: A search of meta-analyses in PubMed, CENTRAL, and Scopus was performed. Meta-analyses including randomized controlled trials (RCTs) comparing open operative repair of ATR and nonoperative treatment with functional rehabilitation regarding reruptures and other complications were identified. RESULTS: Four separate meta-analyses with 6 pooled treatment comparisons were identified. One of the 6 treatment effects (for risk ratio [RR]) showed a reduced risk of rerupture favoring operative treatment, whereas in the remaining analyses the null hypothesis assuming equal risk or an RR of 1 could not be rejected. The smallest RR (benefit in favor of surgery) that could be rejected based on the 95% CI was 0.28. The smallest risk difference that could be rejected in favor of surgery was 6.4%, indicating that nonoperative may have up to 6.4% higher rerupture rate. Treatment effects for complications other than rerupture had very large variability and imprecision. CONCLUSION: The literature comparing surgery with nonoperative treatment using functional rehabilitation in ATR have been interpreted in favor of nonoperative treatment as the rerupture rates were falsely considered "equivalent." None of the published meta-analyses excluded a relative risk that is likely to affect the course of treatment in many cases. Increasing incidence of nonoperative treatment in ATRs is not clearly supported by current evidence.

Minimal important difference and patient acceptable symptom state for the Numerical Rating Scale (NRS) for pain and the Patient-Rated Wrist/Hand Evaluation (PRWHE) for patients with osteoarthritis at the base of thumb.

BACKGROUND: The Numerical Rating Scale (NRS) and Patient-rated wrist/hand evaluation (PRWHE) are patient-reported outcomes frequently used for evaluating pain and function of the wrist and hand. The aim of this study was to determine thresholds for minimal important difference (MID) and patient acceptable symptom state (PASS) for NRS pain and PRWHE instruments in patients with base of thumb osteoarthritis. METHODS: Fifty-two patients with symptomatic base of thumb osteoarthritis wore a splint for six weeks before undergoing trapeziectomy. NRS pain (0 to 10) and PRWHE (0 to 100) were collected at the time of recruitment (baseline), after splint immobilization prior to surgery, and at 3, 6, 9 and 12 months after surgery. Four anchor-based methods were used to determine MID for NRS pain and PRWHE: the receiver operating characteristics (ROC) curve, the mean difference of change (MDC), the mean change (MC) and the predictive modelling methods. Two approaches were used to determine PASS for NRS pain and PRWHE: the 75th percentile and the ROC curve methods. The anchor question for MID was the change perceived by the patient compared with baseline; the anchor question for PASS was whether the patient would be satisfied if the condition were to stay similar. The correlation between the transition anchor at baseline and the outcome at all time points combined was calculated using the Spearman's rho analysis. RESULTS: The MID for NRS pain was 2.5 using the ROC curve method, 2.0 using the MDC method, 2.8 using the MC method, and 2.5 using the predictive modelling method. The corresponding MIDs for PRWHE were 22, 24, 10, and 20. The PASS values for NRS pain and PRWHE were 2.5 and 30 using the ROC curve method, and 2.0 and 22 using the 75th percentile method, respectively. The area under curve (AUC) analyses showed excellent discrimination for all measures. CONCLUSION: We found credible MID estimates for NRS and PRWHE (including its subscales), although the MID estimates varied depending on the method used. The estimates were 20-30% of the range of scores of the instruments. The cut-offs for MID and PASS showed good or excellent discrimination, lending support for their use in future studies. TRIAL REGISTRATION: This clinimetrics study was approved by the Helsinki University ethical review board (HUS1525/2017).