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NCT05031338 Clinical Trial

Carpal Tunnel Release Using Ultrasound

Carpal Tunnel Syndrome Clinical Trial

— CiTRUS  

Official title:
Carpal Tunnel Release Using Ultrasound Patient Experience Registry

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT05031338
Other study ID # CL002
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date July 2, 2021
Est. completion date August 15, 2022

Study information
Verified date August 2022
Source Sonex Health, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Terminated
Enrollment 411
Est. completion date August 15, 2022
Est. primary completion date August 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Carpal Tunnel Release
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.
Procedure:
• Carpal Tunnel Release
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.

Locations
Country Name City State
United States Sonex Health, Inc. Eagan Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Sonex Health, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (7)

Chappell CD, Beckman JP, Baird BC, Takke AV. Ultrasound (US) Changes in the Median Nerve Cross-Sectional Area After Microinvasive US-Guided Carpal Tunnel Release. J Ultrasound Med. 2020 Apr;39(4):693-702. doi: 10.1002/jum.15146. Epub 2019 Oct 29. — View Citation

Henning PT, Yang L, Awan T, Lueders D, Pourcho AM. Minimally Invasive Ultrasound-Guided Carpal Tunnel Release: Preliminary Clinical Results. J Ultrasound Med. 2018 Nov;37(11):2699-2706. doi: 10.1002/jum.14618. Epub 2018 Apr 2. — View Citation

Henning T, Lueders D, Chang K, Yang L. Ultrasound-Guided Carpal Tunnel Release Using Dynamic Expansion of the Transverse Safe Zone in a Patient With Postpolio Syndrome: A Case Report. PM R. 2018 Oct;10(10):1115-1118. doi: 10.1016/j.pmrj.2018.02.016. Epub 2018 Mar 6. — View Citation

Joseph AE, Leiby BM, Beckman JP. Clinical Results of Ultrasound-Guided Carpal Tunnel Release Performed by a Primary Care Sports Medicine Physician. J Ultrasound Med. 2020 Mar;39(3):441-452. doi: 10.1002/jum.15120. Epub 2019 Aug 26. — View Citation

Kamel SI, Freid B, Pomeranz C, Halpern EJ, Nazarian LN. Minimally Invasive Ultrasound-Guided Carpal Tunnel Release Improves Long-Term Clinical Outcomes in Carpal Tunnel Syndrome. AJR Am J Roentgenol. 2021 Aug;217(2):460-468. doi: 10.2214/AJR.20.24383. Epub 2020 Sep 2. — View Citation

Latzka EW, Henning PT, Pourcho AM. Sonographic Changes After Ultrasound-Guided Release of the Transverse Carpal Ligament: A Case Report. PM R. 2018 Oct;10(10):1125-1129. doi: 10.1016/j.pmrj.2018.02.018. Epub 2018 Mar 6. Review. — View Citation

Leiby BM, Beckman JP, Joseph AE. Long-term Clinical Results of Carpal Tunnel Release Using Ultrasound Guidance. Hand (N Y). 2021 Jan 29:1558944720988080. doi: 10.1177/1558944720988080. [Epub ahead of print] — View Citation

Outcome
Type Measure Description Time frame Safety issue
Other Patient reported satisfaction following carpal tunnel release Patient reported satisfaction with the carpal tunnel release procedure on a 1-5 scale with higher numbers indicating greater satisfaction. 2 weeks, 1,3,6 and 12 months
Other Patient reported symptom improvement following carpal tunnel release Patient reported improvement in symptoms following carpal tunnel release, reported on a 1-5 scale with higher numbers indicating more symptom improvement. 2 weeks, 1,3,6 and 12 months
Other Pain reported pain on numerical pain rating scale Patient reported pain following carpal tunnel release, reported on an 11-point (0-10) numerical pain rating scale with higher numbers indicating more pain. Post-operative days 1-14, 2 weeks, 1,3,6 and 12 months
Primary 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
Primary 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 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
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