Carpal Tunnel Release Using Ultrasound

Study Overview
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Brief Summary
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The goal of the Carpal Tunnel Release Using Ultrasound registry (CiTRUS Registry) is to collect experience information from patients scheduled to undergo carpal tunnel release surgery with either the SX-One MicroKnife® with ultrasound guidance or the traditional mini-open technique without US guidance.

Detailed Description
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The CiTRUS registry is an observational study designed to better understand the overall patient experience following a carpal tunnel release surgery using either the SX-One MicroKnife with ultrasound guidance or the traditional mini-open technique without ultrasound guidance. The determination of which surgical technique to uses will be determined by the treating physician and the patient. The patient registry outcomes are intended to help direct future clinical care, educate patients with carpal tunnel syndrome, and design future research.

Official Title
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Carpal Tunnel Release Using Ultrasound Patient Experience Registry

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Device: Carpal Tunnel Release
* Procedure: Carpal Tunnel Release


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled to undergo carpal tunnel release surgery on the right and/or left wrist using either the SX-One MicroKnife with US guidance or the traditional mini-open technique without US guidance 18 years of age or older Agree to complete questionnaires over a 12-month period Valid mobile phone number and email address to receive and answer questions Exclusion Criteria: • Age less than 18 years

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SX-One MicroKnife with ultrasound guidance<br>Carpal Tunnel Release using the SX-One MicroKnife with ultrasound guidance | Device: Carpal Tunnel Release<br>* Carpal Tunnel Release surgery involves transecting the transverse carpal ligament (TCL) in order to reduce median nerve compression and alleviate symptoms. The carpal tunnel release surgery will be performed using the SX-One MicroKnife with ultrasound guidance.<br>Procedure: Carpal Tunnel Release<br>* Carpal Tunnel Release surgery involves transecting the transverse carpal ligament (TCL) in order to reduce median nerve compression and alleviate symptoms. The carpal tunnel release surgery will be performed using the traditional mini-open technique without ultrasound guidance.<br>|
| Traditional mini-open technique without ultrasound guidance<br>Carpal Tunnel Release using the traditional mini-open technique without ultrasound guidance | Device: Carpal Tunnel Release<br>* Carpal Tunnel Release surgery involves transecting the transverse carpal ligament (TCL) in order to reduce median nerve compression and alleviate symptoms. The carpal tunnel release surgery will be performed using the SX-One MicroKnife with ultrasound guidance.<br>Procedure: Carpal Tunnel Release<br>* Carpal Tunnel Release surgery involves transecting the transverse carpal ligament (TCL) in order to reduce median nerve compression and alleviate symptoms. The carpal tunnel release surgery will be performed using the traditional mini-open technique without ultrasound guidance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Quick Form of the Disabilities of the Shoulder and Hand scores at 12 months | To assess the overall patient experience following carpal tunnel release using either the SX-One MicroKnife® with ultrasound (US) guidance or the traditional mini-open technique without ultrasound guidance patients will complete the Quick Form of the Disabilities of the Shoulder and Hand scale. The Quick Form of the Disabilities of the Shoulder and Hand scale consists of 11 items scored 1-5 with lower scores indicating less symptoms or better function. | 12 months | 
| Change from baseline Boston Carpal Tunnel Questionnaire scores at 12 months | To assess the overall patient experience following carpal tunnel release using either the SX-One MicroKnife® with ultrasound guidance or the traditional mini-open technique without ultrasound guidance patients will complete the Boston Carpal Tunnel Questionnaire at 12 months. The Boston Carpal Tunnel Questionnaire consists of two subscales: symptom severity (11 items scored 1-5) and functional status (8 items scored 1-5) with lower scores indicating less symptoms or better function. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported time to return to activities | Patient reported time to return to normal activities as measured in days. | Post-operative days 1-14, 2 weeks, 1,3,6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carpal Tunnel Release, Ultrasound