Dataset Information

Final 1-Year Results of the TUTOR Randomized Trial Comparing Carpal Tunnel Release with Ultrasound Guidance to Mini-open Technique.

ABSTRACT:

Background

Studies comparing carpal tunnel release with ultrasound guidance (CTR-US) to mini-open CTR (mOCTR) are limited. This randomized trial compared the efficacy and safety of these techniques.

Methods

In this multicenter randomized trial, patients were randomized (2:1) to unilateral CTR-US or mOCTR. Outcomes included Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) and Functional Status Scale (BCTQ-FSS), numeric pain scale (0-10), EuroQoL-5 Dimension 5-Level (EQ-5D-5L), scar outcomes, and complications over 1 year.

Results

Patients received CTR-US (n = 94) via wrist incision (mean 6 mm) or mOCTR (n = 28) via palmar incision (mean 22 mm). Comparing CTR-US with mOCTR, the mean changes in BCTQ-SSS (-1.8 versus -1.8; P = 0.96), BCTQ-FSS (-1.0 versus -1.0; P = 0.75), numeric pain scale (-3.9 versus -3.8; P = 0.74), and EQ-5D-5L (0.13 versus 0.12; P = 0.79) over 1 year were comparable between groups. Freedom from scar sensitivity or pain favored CTR-US (95% versus 74%; P = 0.005). Complications occurred in 2.1% versus 3.6% of patients (P = 0.55), all within 3 weeks postprocedure. There was one revision surgery in the CTR-US group, and no revisions for persistent or recurrent symptoms in either group.

Conclusions

CTR-US and mOCTR demonstrated similar improvement in carpal tunnel syndrome symptoms and quality of life with comparable low complication rates over 1 year of follow-up. CTR-US was performed with a smaller incision and associated with less scar discomfort.

SUBMITTER: Eberlin KR

PROVIDER: S-EPMC10911521 | biostudies-literature | 2024 Mar

REPOSITORIES: biostudies-literature

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Publications

Final 1-Year Results of the TUTOR Randomized Trial Comparing Carpal Tunnel Release with Ultrasound Guidance to Mini-open Technique.

Eberlin Kyle R KR Amis Benjamin P BP Berkbigler Thomas P TP Dy Christopher J CJ Fischer Mark D MD Gluck James L JL Kaplan F Thomas D FTD McDonald Thomas J TJ Miller Larry E LE Palmer Alexander A Perry Paul E PE Walker Marc E ME Watt James F JF

Plastic and reconstructive surgery. Global open 20240304 3

<h4>Background</h4>Studies comparing carpal tunnel release with ultrasound guidance (CTR-US) to mini-open CTR (mOCTR) are limited. This randomized trial compared the efficacy and safety of these techniques.<h4>Methods</h4>In this multicenter randomized trial, patients were randomized (2:1) to unilateral CTR-US or mOCTR. Outcomes included Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) and Functional Status Scale (BCTQ-FSS), numeric pain scale (0-10), EuroQoL-5 Dimension 5-Le ...[more]

PMID: 38440365

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Project description:BackgroundCarpal tunnel release (CTR) is a surgical treatment option for patients with carpal tunnel syndrome (CTS) symptoms that are unresponsive to conservative treatment. Most patients experience symptomatic relief after CTR regardless of the surgical technique. However, direct comparisons of the safety and effectiveness between CTR surgical techniques are limited. The purpose of this randomized controlled trial is to compare the safety and effectiveness of CTR with ultrasound guidance (CTR-US) versus mini-open CTR (mOCTR) in subjects with symptomatic CTS.Design and methodsTUTOR (Trial of Ultrasound guided CTR versus Traditional Open Release) is a randomized controlled trial in which 120 subjects at up to 12 sites in the United States will be randomized (2:1) to receive CTR-US or mOCTR. The primary endpoint of the study is the percentage of patients who return to normal daily activities within 3 days of the procedure. Secondary endpoints of the study are median time to return to normal daily activities, percentage of patients who return to work within 3 days of the procedure, median time to return to work, Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) change score at 3 months, BCTQ Functional Status Scale (BCTQ-FSS) change score at 3 months, Numeric Pain Scale change score at 3 months, EuroQoL-5 Dimension 5-Level (EQ-5D-5L) change score at 3 months, and the incidence of device- or procedure-related adverse events at 3 months. Patient follow-up in this trial will continue for 1 year.Ethics and disseminationThis study was approved by a central institutional review board and ongoing trial oversight will be provided by a data safety monitoring board (DSMB). The authors intend to report the results of this trial at medical conferences and peer-reviewed journals. The outcomes of TUTOR will have important clinical and economic implications for all stakeholders involved in treating patients with CTS.Study registrationClinicalTrials.gov (https://clinicaltrials.gov): NCT05405218.Level of evidence1.

Project description:Background Carpal tunnel release (CTR) is a common surgical procedure for patients with severe or refractory carpal tunnel syndrome (CTS) symptoms. Historically, CTR procedures have been performed in a hospital or an ambulatory surgery center (ASC). However, due to advancements in techniques, greater patient demand, and concerns about growing healthcare costs, there is a distinct trend toward performing CTR procedures in an office-based setting. Several small studies with limited follow-up duration have demonstrated the feasibility of CTR with ultrasound guidance (CTR-US) when performed in an office-based setting. The objective of this study is to evaluate the safety and effectiveness of office-based CTR-US in a large cohort of patients (n=140) with symptomatic CTS followed for two years post-treatment. Design and methods ROBUST is a prospective multicenter observational study in which 140 subjects at up to 12 sites in the United States will be treated with CTR-US in an office-based setting. The primary endpoint of the study is the change in the Boston Carpal Tunnel Questionnaire Symptom Severity Scale score. Secondary endpoints include time to return to normal daily activities, time to return to work among employed subjects, change in the Boston Carpal Tunnel Questionnaire Functional Status Scale score, change in the Michigan Hand Questionnaire overall and domain scores, change in the Numeric Pain Scale score, change in the EuroQoL-5 Dimension 5-Level score, global satisfaction scores, and the incidence of device or procedure-related adverse events. The primary analysis of study endpoints will occur three months post-treatment. Patient follow-up in this study will continue for two years. Conclusions A central institutional review board approved the study protocol, and a data safety monitoring board will provide study oversight. The authors plan to report study results at medical conferences and in peer-reviewed medical journals. The outcomes of ROBUST will provide physicians, patients, and payors with important safety and effectiveness data regarding the clinical utility of CTR-US when performed in an office setting.

Project description:PurposeThis study aimed to evaluate the safety and effectiveness of mini-open carpal tunnel release (mOCTR) using best-evidence synthesis methods.MethodsWe systematically searched for prospective studies published from January 2013 to July 2023 that reported outcomes from a minimum of 50 mOCTR cases. The outcomes included Quick Disabilities of the Arm, Shoulder, and Hand Questionnaire, Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) and Functional Status Scale (BCTQ-FSS), pain visual analog scale (VAS), complication rate, and reoperation rate. Data analysis was performed using a random-effects meta-analysis, with metaregression to identify the associations between patient- and study-level factors with surgical outcomes.ResultsThe meta-analysis included 23 studies with 2,303 patients followed for median durations ranging from 6 to 12 months depending on the outcome. Mini-open carpal tunnel release resulted in statistically significant and clinically important improvements in Quick Disabilities of the Arm, Shoulder, and Hand Questionnaire (mean difference = -25.5; 95% confidence interval [CI]: -36.4 to -14.5; P < .001), BCTQ-SSS (mean difference = -2.2; 95% CI: -2.5 to -1.9; P < .001), BCTQ-FSS (mean difference = -2.1; 95% CI: -2.4 to -1.7; P < .001), and pain VAS (mean difference = -5.1; 95% CI: -6.2 to -4.1; P < .001). The sole predictor of improvement in BCTQ-SSS, BCTQ-FSS, and pain VAS was a higher preoperative score for the respective variable (all P < .001). The risk of complications (mainly short-term pillar pain or scar complications) was 8.9% (95% CI: 4.0%-13.8%) and increased with longer incision lengths (P = .008). Revision carpal tunnel release was performed in 0.6% (95% CI: 0.1%-1.0%) of the cases during follow-up. No cases of median nerve transection were reported.ConclusionsBased on a best-evidence meta-analysis of contemporary studies, mOCTR significantly improved function and pain, with a relatively low risk of mainly temporary complications. Patient outcomes after mOCTR were influenced by patient symptomatology and surgical incision length.Clinical relevanceMini-open carpal tunnel release is an effective surgical option that significantly improves symptoms and function, especially for patients with more severe baseline dysfunction. Surgeons should use the shortest incision that allows adequate visualization to safely divide the transverse carpal ligament.

Dataset Information

Final 1-Year Results of the TUTOR Randomized Trial Comparing Carpal Tunnel Release with Ultrasound Guidance to Mini-open Technique.

Background

Methods

Results

Conclusions

Publications

Final 1-Year Results of the TUTOR Randomized Trial Comparing Carpal Tunnel Release with Ultrasound Guidance to Mini-open Technique.

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