Carpal Tunnel Release Using Ultrasound

NCT05031338 | Terminated FDA Device

• 1 other identifier: CL002
• Study Type: observational
• Target: 411
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome

Keywords

Carpal Tunnel Release; Ultrasound

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Patient reported time to return to activities

  Post-operative days 1-14, 2 weeks, 1,3,6 and 12 months

Other Outcomes (3)

• Patient reported satisfaction following carpal tunnel release

  2 weeks, 1,3,6 and 12 months

• Patient reported symptom improvement following carpal tunnel release

  2 weeks, 1,3,6 and 12 months

• Pain reported pain on numerical pain rating scale

  Post-operative days 1-14, 2 weeks, 1,3,6 and 12 months

Study Arms (2)

SX-One MicroKnife with ultrasound guidance

Carpal Tunnel Release using the SX-One MicroKnife with ultrasound guidance

Device: Carpal Tunnel Release; Procedure: Carpal Tunnel Release

Traditional mini-open technique without ultrasound guidance

Carpal Tunnel Release using the traditional mini-open technique without ultrasound guidance

Device: Carpal Tunnel Release; Procedure: Carpal Tunnel Release

Interventions

Carpal Tunnel Release DEVICE

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.

SX-One MicroKnife with ultrasound guidance; Traditional mini-open technique without ultrasound guidance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• 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

You may not qualify if:

• Age less than 18 years

Sponsors & Collaborators

• Sonex Health, Inc.: lead

Study Sites (1)

Sonex Health, Inc.

Eagan, Minnesota, 55121, United States

Location

Related Publications (7)

• 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.

  PMID: 32876476 BACKGROUND

• 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.

  PMID: 31659789 BACKGROUND

• 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.

  PMID: 31449326 BACKGROUND

• 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.

  PMID: 29608024 BACKGROUND

• 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.

  PMID: 29518589 BACKGROUND

• 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.

  PMID: 29518587 BACKGROUND

• 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.

  PMID: 33511873 BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Jay Smith, MD

  Sonex Health, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 1, 2021
• Study Start: July 2, 2021
• Primary Completion: August 1, 2022
• Study Completion: August 15, 2022
• Last Updated: August 18, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)