Clinical trial NCT05031338: Carpal Tunnel Release Using Ultrasound
Official title: Carpal Tunnel Release Using Ultrasound Patient Experience Registry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Carpal Tunnel Syndrome
Keywords: Carpal Tunnel Release
Ultrasound
Lead sponsor: Sonex Health, Inc.
Sponsor class: INDUSTRY
First posted: 2021-09-01
Enrollment: 411
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled to undergo carpal tunnel release surgery using either the SX-One MicroKnife® with ultrasound (US) guidance or the traditional mini-open technique without ultrasound guidance.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline Quick Form of the Disabilities of the Shoulder and Hand scores at 12 months
timeFrame: 12 months
measure: Change from baseline Boston Carpal Tunnel Questionnaire scores at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Patient reported time to return to activities
timeFrame: Post-operative days 1-14, 2 weeks, 1,3,6 and 12 months
Other outcomes:
measure: Patient reported satisfaction following carpal tunnel release
timeFrame: 2 weeks, 1,3,6 and 12 months
measure: Patient reported symptom improvement following carpal tunnel release
timeFrame: 2 weeks, 1,3,6 and 12 months
measure: Pain reported pain on numerical pain rating scale
timeFrame: Post-operative days 1-14, 2 weeks, 1,3,6 and 12 months
Locations:
city: Eagan
country: United States
facility: Sonex Health, Inc.
state: Minnesota
Study officials:
affiliation: Sonex Health, Inc.
name: Jay Smith, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.
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.
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.
citation: Leiby BM, Beckman JP, Joseph AE. Long-term Clinical Results of Carpal Tunnel Release Using Ultrasound Guidance. Hand (N Y). 2022 Nov;17(6):1074-1081. doi: 10.1177/1558944720988080. Epub 2021 Jan 29.