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.

Bias in Hand Surgical Randomized Controlled Trials: Systematic Review and Meta-Epidemiological Study.

PURPOSE: Inappropriately reported or conducted studies may decrease the quality of care due to under- or overestimation of the benefits or harms of interventions. Our aim was to evaluate how often hand surgical randomized controlled trials (RCTs) use and report adequate methods to ensure internal validity, and whether inadequate reporting or methods are associated with the magnitude of treatment effect estimates. METHODS: Data Sources were the Cochrane Central Register of Controlled Trials, MEDLINE, and Embase databases until November 2020. We included published RCTs investigating the effects of any surgical intervention in the hand and wrist region. We assessed internal validity using the Cochrane Risk of Bias (RoB) tool for 6 domains: selection, performance, detection, attrition, selective reporting, and "other" bias. We extracted the primary outcome and calculated the effect size for each study. We used mixed-effect meta-regression to assess whether the RoB modified the magnitude of the effects. RESULTS: For 207 assessed trials, the RoB was unclear or high for 72% in selection, 93% in performance, 88% in detection, 25% in attrition, 22% in selective reporting, and 34% in the "other" bias domain. Trials with a high or unclear risk of selection bias yielded 0.28 standardized mean difference (95% confidence interval, 0.02-0.55) larger effect sizes compared to studies with a low risk. Risks of bias for other domains did not modify the intervention effects. The risk for selection bias declined over time: the odds ratio for a high or unclear RoB was 0.90 (95% confidence interval, 0.85-0.95) per additional year of publication CONCLUSIONS: The internal validity and credibility of hand surgical RCTs can be improved by using established methods to achieve true randomization, blinding of the participants and study personnel, publishing the trial protocol and avoiding selective reporting of the outcomes, and reporting the trial as recommended in the Consolidated Standards of Reporting Trials statement. CLINICAL RELEVANCE: Clinicians should be aware that RCTs that do not use or report proper randomization and allocation concealment may overestimate the treatment effects.

Update on Efficacy of Conservative Treatments for Carpal Tunnel Syndrome.

Carpal tunnel syndrome (CTS) is the most common upper extremity compression neuropathy. Non-operative interventions are usually the first-line treatments, and surgery is reserved for those that do not achieve a satisfactory symptom state by non-operative means. This narrative review summarizes the current evidence regarding the efficacy of orthoses, corticosteroid injections, platelet-rich plasma injections, Kinesio taping, neurodynamic techniques, gabapentin, therapeutic ultrasound, and extracorporeal shockwave therapy in people with CTS. While many trials suggest small short-term benefits, rigorous evidence of long-term patient-important benefits is limited. To improve the utility of healthcare resources, research in this area should focus on establishing efficacy of each treatment instead of comparing various treatments with uncertain benefits.

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.