Registry of the Patient Experience for Carpal Tunnel Release (MISSION)

Sonex Health

Status: Active, not recruiting

Conditions: Carpal Tunnel Syndrome; CTS

Treatments: Procedure: Endocscopic CTR; Device: UltraGuideCTR (Device) with Ultrasound Guided Carpal Tunnel Release (CTR-US); Procedure: Open CTR

Study type: Observational

Funder types: Industry

Identifiers

NCT06071468

90154-TP

Details and patient eligibility

About

Multi-center study to collect large scale, multidimensional real-world data on patients undergoing carpal tunnel release (CTR).

Full description

Multicenter prospective Registry of patients with symptomatic carpal tunnel syndrome (CTS) treated (unilateral or simultaneous bilateral) by Ultrasound guided CTR (CTR-US), Endoscopic CTR (ECTR), or Open CTR (OCTR).

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria 1. ≥18 years of age 2. Clinical diagnosis of unilateral or bilateral CTS 3. A clinical decision has been made to perform CTR on one or both hands 4. CTS-6 score ≥12 in the target hand(s)* 5. Confirmatory diagnostic testing in the target hand(s)*:

1. CTR-US: Confirmatory diagnostic testing with ultrasound (median nerve cross-sectional area ≥10 mm2 in the proximal carpal tunnel region)
2. ECTR or OCTR: Confirmatory electrodiagnostic testing 6. Prior failure of one or more nonsurgical treatment options (e.g., physical activity modification, bracing, splinting, corticosteroid injection) in the target hand(s) 7. Patient agrees to complete follow-up questionnaires over a 24-month period 8. Patient has a valid smart phone number and/or email address to receive and answer follow-up questionnaires

Note: An asterisk (*) denotes that this criterion must be applied to the target hand for unilateral CTR procedures, or to both hands for simultaneous bilateral CTR procedures.

Exclusion Criteria:

1. Patient meets any of the contraindications per Instruction For Use (IFU)
2. Patient has other medical, social, or psychological conditions that, in the opinion of the investigator, preclude them from completing all registry requirements.

Trial design

2,000 participants in 3 patient groups

Ultrasound Guided Carpal Tunnel Release (CTR-US)

Description:

Carpal Tunnel Release using CTR-US technique

Treatment:

Device: UltraGuideCTR (Device) with Ultrasound Guided Carpal Tunnel Release (CTR-US)

Open Carpal Tunnel Release (OCTR)

Description:

Carpal Tunnel Release Using Open Carpal Tunnel Release (OCTR)

Treatment:

Procedure: Open CTR

Endoscopic Carpal Tunnel Release (ECTR)

Description:

Carpal Tunnel Release Using Endoscopic Carpal Tunnel Release (ECTR)

Treatment:

Procedure: Endocscopic CTR