Clinical trial NCT06071468: Registry of the Patient Experience for Carpal Tunnel Release
Official title: Registry of the Patient Experience for Carpal Tunnel Release (MISSION)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carpal Tunnel Syndrome
CTS
Keywords: Ultrasound Guided Carpal Tunnel Release
CTR-US
ECTR
OCTR
Lead sponsor: Sonex Health, Inc.
Sponsor class: INDUSTRY
First posted: 2023-10-06
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Carpal Tunnel Syndrome meeting study eligibility criteria. Patients are invited to volunteer to participate at selected study sites.

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

Detailed 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).

Eligibility 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.

Primary outcomes:
measure: Boston Carpal Tunnel Questionnaire - Symptom Severity Scale (BCTQ-SSS)
timeFrame: 24 Months
Secondary outcomes:
measure: Boston Carpal Tunnel Questionnaire - Functional Status Scale (BCTQ-FSS)
timeFrame: 24 Months
measure: Numeric Pain Scale
timeFrame: 24 Months
measure: EuroQoL 5-Dimension 5-Level (EQ-5D-5L)
timeFrame: 24 Months
measure: Device and/or Procedure Related Adverse Events
timeFrame: 24 Months
measure: Global Satisfaction with Carpal Tunnel Release Procedure
timeFrame: 24 Months
Other outcomes:
measure: Pain medication use through 24 months
timeFrame: 24 Months
measure: Additional surgical interventions through 24 months
timeFrame: 24 Months
Locations:
city: Foley
country: United States
facility: The Orthopaedic Group P.C. (CTR-US)
state: Alabama
city: Scottsdale
country: United States
facility: Phoenix Hand (CTR-US)
state: Arizona
city: Glastonbury
country: United States
facility: Orthopaedics Associates of Hartford (OCTR)
state: Connecticut
city: Aventura
country: United States
facility: Aventura Hand Center (CTR-US)
state: Florida
city: Fort Walton Beach
country: United States
facility: Orthopaedic Associates (CTR-US)
state: Florida
city: Gainesville
country: United States
facility: The Orthopaedic Institute (CTR-US)
state: Florida
city: Lakeland
country: United States
facility: Central Florida Orthopaedic Surgery Associates, P.L (CTR-US)
state: Florida
city: Melbourne
country: United States
facility: Melbourne Hand Center (OCTR)
state: Florida
city: Miami Lakes
country: United States
facility: The Orthopaedic Hand and Arm Center (CTR-US)
state: Florida
city: Miami
country: United States
facility: Miami Hand Center (NHVP)
state: Florida
city: Decatur
country: United States
facility: JMS Hand Associates (CTR-US)
state: Illinois
city: Evansville
country: United States
facility: Tri-State Orthopaedics (CTR-US)
state: Indiana
city: Lexington
country: United States
facility: Bluegrass Orthopaedics (CTR-US)
state: Kentucky
city: Hyannis
country: United States
facility: Cape Cod Orthopaedics (CTR-US)
state: Massachusetts
city: Woburn
country: United States
facility: Excel Orthopaedic Specialists (CTR-US)
state: Massachusetts
city: Troy
country: United States
facility: Mendelson Orthopedic PC (CTR-US)
state: Michigan
city: Edina
country: United States
facility: Twin Cities Orthopedics (OCTR)
state: Minnesota
city: Jackson
country: United States
facility: Mississippi Sports Medicine& Orthopedic Center (ECTR)
state: Mississippi
city: Saint Louis
country: United States
facility: Orthopedic Asociates (CTR-US)
state: Missouri
city: Las Vegas
country: United States
facility: Hand Center of Nevada (CTR-US)
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Clinic (ECTR)
state: New Hampshire
city: Salem
country: United States
facility: Mobility Bone and Joint Institute (CTR-US)
state: New Hampshire
city: Albuquerque
country: United States
facility: New Mexico Orthopedics (CTR-US)
state: New Mexico
city: Amherst
country: United States
facility: Buffalo Surgery Center (CTR-US)
state: New York
city: Raleigh
country: United States
facility: The Bone&Joint Surgery Clinic (CTR-US)
state: North Carolina
city: Oklahoma City
country: United States
facility: Integris Health (CTR-US)
state: Oklahoma
city: Tulsa
country: United States
facility: Northeast Oklahoma Hand and Upper Extremity Surgery (CTR-US)
state: Oklahoma
city: Bend
country: United States
facility: The Center (ECTR)
state: Oregon
city: Eugene
country: United States
facility: Slocum Research & Education Foundation (ECTR)
state: Oregon
city: Meadville
country: United States
facility: Meadville Medical Center (ECTR)
state: Pennsylvania
city: State College
country: United States
facility: University Orthopedics Center (OCTR)
state: Pennsylvania
city: East Providence
country: United States
facility: University Orthopedics, Inc.(OCTR)
state: Rhode Island
city: Conway
country: United States
facility: Ortho SC (CTR-US)
state: South Carolina
city: Greenville
country: United States
facility: Prisma Health (ECTR)
state: South Carolina
city: Jackson
country: United States
facility: Sports Orthopedics & Spine (CTR-US)
state: Tennessee
city: Denton
country: United States
facility: North Texas Hand Center (CTR-US)
state: Texas
city: Fort Worth
country: United States
facility: North Texas Orthopedics and Spine Center (CTR-US)
state: Texas
Study officials:
affiliation: Bluegrass Orthopaedics
name: Victor M Marwin, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: