Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy and affects 3-6% of adults in the United States. In patients with severe or refractory symptoms, carpal tunnel release (CTR) represents the definitive management option, and over 550,000 CTRs are performed annually in the United States with over 90% of patients reporting clinical improvement. Currently available CTR techniques include mini-open CTR via a single, 1-3 cm palmar incision (mOCTR), endoscopic CTR via one (wrist) or two (wrist and palm) 1-2 cm incisions (ECTR), and ultrasound guided CTR via a single \< 1 cm wrist or palmar incision (USCTR or CTR-US). The primary objective is to assess the impact of USCTR vs mOCTR in a military population. Investigators hypothesize that USCTR using the SX-One MicroKnife, also known as UltraGuideCTR, will safely and non-inferiorly improve symptoms of carpal tunnel syndrome compared to traditional mOCTR, without greater less loss of military duty days. This study is a single-site randomized controlled trial. Participants with CTS will be randomized to a study arm and receive treatment with USCTR vs. traditional mOCTR. All patients will be followed for a period of 24 months with respect to standard clinical data, military relevant data, and validated patient related outcome measures (PROMs). Data will be collected at 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, and 12 months, and 24 months post-CTR procedure, with the primary focus being on outcomes up to 1 year.
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Measure the effect of USCTR vs mOCTR on the longitudinal change in QuickDASH.
Timeframe: Change from baseline to 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure
Measure the effect of USCTR vs mOCTR on the longitudinal change in BCTQ-SSS.
Timeframe: Change from baseline to 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure
Measure the effect of USCTR vs mOCTR on the longitudinal change in hand grip strength.
Timeframe: Change from baseline to 3 months, and 12 months post CTR procedure
Measure the effect of USCTR vs mOCTR on the longitudinal change in pinch (tip, palmar, and key) strength.
Timeframe: Change from baseline to 3 months, and 12 months post CTR procedure
Measure the impact of USCTR vs mOCTR on participant perception of change in overall physical condition
Timeframe: Change from 1 week to 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure
Change in military work status as assessed using single-item self-report assessment
Timeframe: Captured at 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure
Surgical time during procedure (minutes)
Timeframe: At time of procedure, measured as day 0
Change in self-reported satisfaction as assessed using a satisfaction rating scale
Timeframe: Captured at 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure
Change in self-reported pain as assessed using the 11-item Numeric Pain Rating Scale (NPRS) participant pain levels over 1 month following the CTR procedure.
Timeframe: Captured at 1 week, 2 weeks, 3 weeks, and 1 month post CTR procedure
Change in pain medication usage as assessed using single-item self-report assessment
Timeframe: Captured at 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure
Incision length in cm
Timeframe: At time of procedure, measured as day 0
Change in self-reported pain as assessed using the 11-item Numeric Pain Rating Scale (NPRS)
Timeframe: At time of procedure, measured as day 0
Change in self-reported pain as assessed using the modified 2-item CTS Palmar Pain Scale (4 items) over 1 month following CTR procedure
Timeframe: Captured at 1 week, 2 weeks, 3 weeks, and 1 month post CTR procedure