Clinical Outcomes of USCTR vs. mOCTR

Study Overview
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Brief Summary
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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). The primary objective is to assess the impact of USCTR vs mOCTR in a military population. This study is a multi-site prospective randomized comparative trial. Participants with CTS will be randomized to a study arm and receive treatment with ultrasound guided carpal tunnel release (USCTR) vs. traditional mini-open carpal tunnel release (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. Investigators hypothesize that USCTR using the SX-One MicroKnife® will safely and more-effectively improve symptoms of carpal tunnel syndrome compared to traditional mOCTR, with less loss of military duty days.

Official Title
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Clinical Outcomes of Carpal Tunnel Release With and Without Ultrasound Guidance

Conditions
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Carpal Tunnel

Intervention / Treatment
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* Device: USCTR
* Procedure: mOCTR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults age ≥18 years DEERS Eligible Fluent in speaking, reading, and understanding English Clinical diagnosis of Carpal Tunnel Syndrome (CTS) Candidate for surgical CTR based on severe and/or refractory symptoms Confirmatory electrodiagnostic test indicating median neuropathy at the wrist (abnormal findings) Ultrasound findings consistent with median nerve enlargement in the carpal tunnel Exclusion Criteria: Previous carpal tunnel release or previous wrist surgery on the ipsilateral side Carpal tunnel injection with corticosteroid within 6 weeks prior to anticipated study procedure Previous traumatic injury to the median nerve or any of its branches on the ipsilateral side History of medical condition that would preclude safe participation in study procedures (e. g. complex regional pain syndrome (CRPS), upper limb vascular disease (including thoracic outlet syndrome), Raynaud's phenomenon, etc.) Inability to stop anticoagulation medications (Plavix, Coumadin/Warfarin, Xarelto), or unable to be bridged with Lovenox Unable to understand and provide written informed consent Contraindication to proceeding with USCTR based on diagnostic ultrasound (i.e. identification of anomalous anatomic structures such as bifid median nerve or space occupying lesions within the carpal tunnel) Electrodiagnostic evaluation of the carpal tunnel which indicates normal findings

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: USCTR Procedure<br>Participants will undergo the USCTR procedure with SX-One MicroKnife® | Device: USCTR<br>* Ultrasound guided CTR via a single < 1 cm wrist or palmar incision. The procedure will be performed using the SX-One MicroKnife®<br>|
| Active Comparator: mOCTR Procedure<br>Participants will undergo the traditional mOCTR procedure. | Procedure: mOCTR<br>* Mini-open CTR via a single 1-3cm palmar incision<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the effect of USCTR vs mOCTR on the longitudinal change in QuickDASH. | QuickDash is a region-specific PROM consisting of 11 items measuring the difficulty in performing physical activities relevant to shoulder, arm or hand function. Each item is scored on a scale of 1-5 and a final score of 0 to 100 is calculated, with higher scores representing greater degrees of upper extremity disability (0 points indicate no disability and 100 points indicates maximum disability). | 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-S. | The BCTQ is a PROM for CTS and is the most commonly used outcome measure for CTS. Each item on the 11-item symptom severity scale (BCTQ-S) is graded from 1 (mildest) to 5 (most severe). Outcomes are typically recorded as a mean score. | 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 pinch and grip strength. | Manually tested using a dynamometer. | 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 | Participant self reported change in physical condition. Participant will select one response from the following descriptions to rate overall condition from the time they began treatment to the designated time-point: A very great deal worse; About the same; A very great deal better; A great deal worse; A great deal better; Quite a bit worse; Quite a bit better; Moderately worse; Moderately better; Somewhat worse; Somewhat better; A little bit worse; A little bit better; A tiny bit worse(almost the same); A tiny bit better (almost the same) | 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 | Participants will complete a questionnaire to depict when normal work or daily activities commenced. | 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) | On the day the participant receives their study assigned procedure (USCTR vs. mOCTR), clinical team will record surgical time to perform the procedure in minutes | At time of procedure, measured as day 0 | 
| Change in self-reported satisfaction as assessed using a satisfaction rating scale | Participants will rate satisfaction with the following: completely dissatisfied, mostly dissatisfied, somewhat satisfied, neither satisfied or dissatisfied, somewhat satisfied, mostly satisfied, or completely satisfied. Completely dissatisfied with represent the lowest score, and completely satisfied will represent the highest score. | 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 Pain Numeric Rating Scale (NRS) participant pain levels over 1 month following the CTR procedure. | The 11-item NRS scale is a unidimensional measure of pain intensity. It is a segmented numeric version of the visual analog scale in which participants will select a whole number (0-10 integers) that best reflects the intensity of their pain. The scale ranges from '0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. worst possible pain). | 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 | Participant self-reported pain medication usage. Participant will respond with responses ranging from less than once a week', once a week, several times a week, daily, multiple times per day, or did not use. Did not use will represent the minimum value, and multiple times per day will represent the maximum value. | 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 | On the day the participant receives their study assigned procedure (USCTR vs. mOCTR), clinical team will record incision length in cm | At time of procedure, measured as day 0 | 
| Change in self-reported pain as assessed using the 11-item Pain Numeric Rating Scale (NRS) | Using the 11-item Pain Numeric Rating Scale (NRS), compare the distributions of participant self-reported pain at both pre- and immediately -post CTR procedure between the USCTR and mOCTR groups. The 11-item NRS scale is a unidimensional measure of pain intensity. It is a segmented numeric version of the visual analog scale in which participants will select a whole number (0-10 integers) that best reflects the intensity of their pain. The scale ranges from '0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. worst possible pain). | At time of procedure, measured as day 0 | 
| Change in self-reported pain as assessed using the 4-item CTS Palmar Pain Scale over 1 month following CTR procedure | The 4-item Carpal Tunnel Syndrome Palmer and Incision Pain questionnaire inquiries about severity of pain. Each item has five-six possible response options which range from 1 (no pain) to 5/6 (very severe). The symptom score is the mean of all answered items; higher scores indicate worse symptoms | Captured at 1 week, 2 weeks, 3 weeks, and 1 month post CTR procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Median Nerve Neuropathy Treatments, Ultrasound Guided Carpal Tunnel Release (USCTR), Military, Minimally Invasive Carpal Tunnel Release