Trial of ultrasound guided carpal tunnel release versus traditional open release (TUTOR)

Kyle R Eberlin, Christopher J Dy, Mark D Fischer, James L Gluck, F Thomas D Kaplan, Thomas J McDonald, Larry E Miller, Alexander Palmer, Marc E Walker, James F Watt, Kyle R Eberlin, Christopher J Dy, Mark D Fischer, James L Gluck, F Thomas D Kaplan, Thomas J McDonald, Larry E Miller, Alexander Palmer, Marc E Walker, James F Watt

Abstract

Background: Carpal 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 methods: TUTOR (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 dissemination: This 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 registration: ClinicalTrials.gov (https://ichgcp.net/clinical-trials-registry/NCT05405218" title="See in ClinicalTrials.gov">NCT05405218.

Level of evidence: 1.

Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.

References

    1. Atroshi I, Gummesson C, Johnsson R, et al. . Prevalence of carpal tunnel syndrome in a general population. Jama. 1999;282:153–8.
    1. Chammas M. Carpal tunnel syndrome. Chir Main. 2014;33:75–94.
    1. Padua L, Coraci D, Erra C, et al. . Carpal tunnel syndrome: clinical features, diagnosis, and management. Lancet Neurol. 2016;15:1273–84.
    1. Graham B, Peljovich AE, Afra R, et al. . The American academy of orthopaedic surgeons evidence-based clinical practice guideline on: management of carpal tunnel syndrome. J Bone Joint Surg Am. 2016;98:1750–4.
    1. Tulipan JE, Ilyas AM. Carpal tunnel syndrome surgery: what you should know. Plastic Reconstructive Surg – Global Open. 2020;8:e2692.
    1. Evers S, Bryan AJ, Sanders TL, et al. . Corticosteroid injections for carpal tunnel syndrome: long-term follow-up in a population-based cohort. Plast Reconstr Surg. 2017;140:338–47.
    1. Sears ED, Swiatek PR, Chung KC. National utilization patterns of steroid injection and operative intervention for treatment of common hand conditions. J Hand Surg Am. 2016;41:367–373.e2.
    1. Wojahn RD, Foeger NC, Gelberman RH, et al. . Long-term outcomes following a single corticosteroid injection for trigger finger. J Bone Joint Surg Am. 2014;96:1849–54.
    1. Mason W, Ryan D, Khan A, et al. . Injection versus decompression for carpal tunnel syndrome-pilot trial (INDICATE-P)-protocol for a randomised feasibility study. Pilot Feasibility Stud. 2017;3:20.
    1. Greenfield PT, Spencer CC, Dawes A, et al. . The preoperative cost of carpal tunnel syndrome. J Hand Surg Am. 2022;47:752–61.
    1. Leinberry CF, Rivlin M, Maltenfort M, et al. . Treatment of carpal tunnel syndrome by members of the American society for surgery of the hand: a 25-year perspective. J Hand Surg Am. 2012;37:1997–2003.e3.
    1. Kim PT, Lee HJ, Kim TG, et al. . Current approaches for carpal tunnel syndrome. Clin Orthop Surg. 2014;6:253–7.
    1. Fajardo M, Kim SH, Szabo RM. Incidence of carpal tunnel release: trends and implications within the United States ambulatory care setting. J Hand Surg Am. 2012;37:1599–605.
    1. Li Y, Luo W, Wu G, et al. . Open versus endoscopic carpal tunnel release: a systematic review and meta-analysis of randomized controlled trials. BMC Musculoskelet Disord. 2020;21:272.
    1. Vasiliadis HS, Nikolakopoulou A, Shrier I, et al. . Endoscopic and open release similarly safe for the treatment of carpal tunnel syndrome. A systematic review and meta-analysis. PLoS One. 2015;10:e0143683e0143683.
    1. Murthy PG, Goljan P, Mendez G, et al. . Mini-open versus extended open release for severe carpal tunnel syndrome. Hand (N Y). 2015;10:34–9.
    1. Cellocco P, Rossi C, Bizzarri F, et al. . Mini-open blind procedure versus limited open technique for carpal tunnel release: a 30-month follow-up study. J Hand Surg Am. 2005;30:493–9.
    1. Williamson ERC, Vasquez Montes D, Melamed E. Multistate comparison of cost, trends, and complications in open versus endoscopic carpal tunnel release. Hand (N Y). 2021;16:25–31.
    1. Shin EK. Endoscopic versus open carpal tunnel release. Curr Rev Musculoskelet Med. 2019;12:509–14.
    1. Wang PH, Li CL, Shao CJ, et al. . Ultrasound-guided percutaneous carpal tunnel release in patients on hemodialysis: early experiences and clinical outcomes. Ther Clin Risk Manag. 2019;15:711–7.
    1. Petrover D, Silvera J, De Baere T, et al. . Percutaneous ultrasound-guided carpal tunnel release: study upon clinical efficacy and safety. Cardiovasc Intervent Radiol. 2017;40:568–75.
    1. Rojo-Manaute JM, Capa-Grasa A, Chana-Rodríguez F, et al. . Ultra-minimally invasive ultrasound-guided carpal tunnel release: a randomized clinical trial. J Ultrasound Med. 2016;35:1149–57.
    1. Lecoq B, Hanouz N, Morello R, et al. . Ultrasound-assisted surgical release of carpal tunnel syndrome: results of a pilot open-label uncontrolled trial conducted outside the operating theatre. Joint Bone Spine. 2015;82:442–5.
    1. Chern TC, Kuo LC, Shao CJ, et al. . Ultrasonographically guided percutaneous carpal tunnel release: early clinical experiences and outcomes. Arthroscopy. 2015;31:2400–10.
    1. Capa-Grasa A, Rojo-Manaute JM, Rodriguez FC, et al. . Ultra minimally invasive sonographically guided carpal tunnel release: an external pilot study. Orthop Traumatol Surg Res. 2014;100:287–92.
    1. Markison RE. Percutaneous ultrasound-guided MANOS carpal tunnel release technique. Hand. 2013;8:445–9.
    1. Buncke G, McCormack B, Bodor M. Ultrasound-guided carpal tunnel release using the manos CTR system. Microsurgery. 2013;33:362–6.
    1. Nakamichi K, Tachibana S. Ultrasonographically assisted carpal tunnel release. J Hand Surg Am. 1997;22:853–62.
    1. Nakamichi K, Tachibana S, Yamamoto S, et al. . Percutaneous carpal tunnel release compared with mini-open release using ultrasonographic guidance for both techniques. J Hand Surg Am. 2010;35:437–45.
    1. Wang PH, Wu PT, Jou IM. Ultrasound-guided percutaneous carpal tunnel release: 2-year follow-up of 641 hands. J Hand Surg Eur Vol. 2021;46:305–7.
    1. Hebbard P, Thomas P, Fransch SV, et al. . Microinvasive carpal tunnel release using a retractable needle-mounted blade. J Ultrasound Med. 2021;40:1451–8.
    1. Fowler JR, Chung KC, Miller LE. Multicenter pragmatic study of carpal tunnel release with ultrasound guidance. Expert Rev Med Devices. 2022;19:273–80.
    1. Chan AW, Tetzlaff JM, Gotzsche PC, et al. . SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586.
    1. Fowler JR, Munsch M, Tosti R, et al. . Comparison of ultrasound and electrodiagnostic testing for diagnosis of carpal tunnel syndrome: study using a validated clinical tool as the reference standard. J Bone Joint Surg Am. 2014;96:e148.
    1. Tran TA, Williams LM, Bui D, et al. . Prospective pilot study comparing pre- and postsurgical CTSAQ and Neuro-QoL questionnaire with median nerve high-resolution ultrasound cross-sectional areas. J Hand Surg Am. 2018;43:184 e181–184 e189.
    1. Ozer K, Malay S, Toker S, et al. . Minimal clinically important difference of carpal tunnel release in diabetic and nondiabetic patients. Plast Reconstr Surg. 2013;131:1279–85.
    1. Levine DW, Simmons BP, Koris MJ, et al. . A self-administered questionnaire for the assessment of severity of symptoms and functional status in carpal tunnel syndrome. J Bone Joint Surg Am. 1993;75:1585–92.
    1. Herdman M, Gudex C, Lloyd A, et al. . Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011;20:1727–36.

Source: PubMed

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

3
Sottoscrivi