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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Carpal Tunnel Syndrome; CTS
• Intervention / Treatment: Device: UltraGuideCTR (Device) with Ultrasound Guided Carpal Tunnel Release (CTR-US); Procedure: Open CTR; Procedure: Endocscopic 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).

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Foley, Alabama, United States, 36535
      • The Orthopaedic Group P.C. (CTR-US)
  • Arizona
    • Scottsdale, Arizona, United States, 85260
      • Phoenix Hand (CTR-US)
  • Connecticut
    • Glastonbury, Connecticut, United States, 06033
      • Orthopaedics Associates of Hartford (OCTR)
  • Florida
    • Aventura, Florida, United States, 33180
      • Aventura Hand Center (CTR-US)
    • Fort Walton Beach, Florida, United States, 32547
      • Orthopaedic Associates (CTR-US)
    • Lakeland, Florida, United States, 74137
      • Central Florida Orthopaedic Surgery Associates, P.L (CTR-US)
    • Melbourne, Florida, United States, 32935
      • Melbourne Hand Center (OCTR)
    • Miami, Florida, United States, 33133
      • Miami Hand Center (NHVP)
    • Miami Lakes, Florida, United States, 33014
      • The Orthopaedic Hand and Arm Center (CTR-US)
  • Indiana
    • Evansville, Indiana, United States, 47715
      • Tri-State Orthopaedics (CTR-US)
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Bluegrass Orthopaedics (CTR-US)
  • Massachusetts
    • Hyannis, Massachusetts, United States, 02601-3825
      • Cape Cod Orthopaedics (CTR-US)
    • Woburn, Massachusetts, United States, 01801
      • Excel Orthopaedic Specialists (CTR-US)
  • Michigan
    • Troy, Michigan, United States, 48080
      • Mendelson Orthopedic PC (CTR-US)
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • Twin Cities Orthopedics (OCTR)
  • Mississippi
    • Jackson, Mississippi, United States, 39202
      • Mississippi Sports Medicine& Orthopedic Center (ECTR)
  • Missouri
    • St Louis, Missouri, United States, 63131
      • Orthopedic Asociates (CTR-US)
  • Nevada
    • Las Vegas, Nevada, United States, 89123
      • Hand Center of Nevada (CTR-US)
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth Hitchcock Clinic (ECTR)
    • Salem, New Hampshire, United States, 03079
      • Mobility Bone and Joint Institute (CTR-US)
  • New Mexico
    • Albuquerque, New Mexico, United States, 87110
      • New Mexico Orthopedics (CTR-US)
  • New York
    • Amherst, New York, United States, 14226
      • Buffalo Surgery Center (CTR-US)
  • North Carolina
    • Raleigh, North Carolina, United States, 27609
      • The Bone&Joint Surgery Clinic (CTR-US)
  • Oregon
    • Bend, Oregon, United States, 97701
      • The Center (ECTR)
    • Eugene, Oregon, United States, 97401
      • Slocum Research & Education Foundation (ECTR)
  • Pennsylvania
    • Meadville, Pennsylvania, United States, 16335
      • Meadville Medical Center (ECTR)
    • State College, Pennsylvania, United States, 16801
      • University Orthopedics Center (OCTR)
  • Rhode Island
    • East Providence, Rhode Island, United States, 02914
      • University Orthopedics, Inc.(OCTR)
  • South Carolina
    • Conway, South Carolina, United States, 29526
      • Ortho SC (CTR-US)
    • Greenville, South Carolina, United States, 29615
      • Prisma Health (ECTR)
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • Sports Orthopedics & Spine (CTR-US)
  • Texas
    • Denton, Texas, United States, 76210
      • North Texas Hand Center (CTR-US)
    • Fort Worth, Texas, United States, 76244
      • North Texas Orthopedics and Spine Center (CTR-US)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ultrasound Guided Carpal Tunnel Release (CTR-US); Carpal Tunnel Release using CTR-US technique	Device: UltraGuideCTR (Device) with Ultrasound Guided Carpal Tunnel Release (CTR-US); The UltraGuideCTR is a commercially available medical device specifically developed to facilitate CTR-US. The device is a single-use, hand-held device that is inserted into the carpal tunnel through a small (typically < 5 mm) wrist incision using continuous US guidance. The working tip of the UltraGuideCTR consists of two inflatable balloons that border a centrally located, retractable retrograde cutting knife. When inflated with sterile saline, the balloons increase the diameter of the tip from 4 mm to 8 mm. After the tip is positioned within the transverse safe zone of the carpal tunnel, the balloons are inflated to create space in the carpal tunnel, the blade is activated, and the TCL is transected in a retrograde manner. Following TCL transection, the blade is recessed, the balloons deflated, and the device is removed. The TCL is probed to ensure a complete release. The entire procedure is performed using US guidance.
Open Carpal Tunnel Release (OCTR); Carpal Tunnel Release Using Open Carpal Tunnel Release (OCTR)	Procedure: Open CTR; OCTR is the most commonly used CTR technique in the United States.The key procedural steps involved in OCTR are listed below.; Following the delivery of anesthesia, an incision is made in the palm directly over the carpal tunnel.; The surgeon cuts through the palmar fascia to identify the TCL.; The surgeon transects the TCL with a scalpel and/or similar cutting instruments.; The surgeon inspects the carpal tunnel to ensure proper decompression.; The wound is closed with sutures.; Other Names: OCTR
Endoscopic Carpal Tunnel Release (ECTR); Carpal Tunnel Release Using Endoscopic Carpal Tunnel Release (ECTR)	Procedure: Endocscopic CTR; Endoscopic CTR makes one or two short incisions to introduce instruments for visualizing. The key procedural steps involved in Endoscopic CTR are listed below.; Following the delivery of anesthesia, the surgeon makes a small wrist incision (usually less than 1.5 cm), with or without a small palmar incision (usually less than 1.5 cm, depending on whether they are using a single portal or double portal technique, respectively.; A series of dilators and raspers are used to create space in the carpal tunnel and clear synovial tissue from the undersurface fo the TCL.; A camera attached to a narrow tube (endoscope) is inserted into the carpal tunnel.; The transverse carpal ligament (which forms the roof of the carpal tunnel) is identified.; Using specialized cutting instruments and endoscopic guidance, the surgeon transects the TCL.; Endoscopic visualization and/or probing are used to confirm a complete release.; The wound(s) is/are typically closed with sutures.; Other Names: ECTR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Boston Carpal Tunnel Questionnaire - Symptom Severity Scale (BCTQ-SSS)	Scoring for the BCTQ- SSS ranges from 1 to 5, with higher scores indicating more severe symptoms, and is calculated as the mean of each response. The change in BCTQ-SSS score at the 24-month follow-up relative to baseline.	24 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Boston Carpal Tunnel Questionnaire - Functional Status Scale (BCTQ-FSS)	Scoring for the BCTQ-FSS ranges from 1 to 5, with higher scores indicating more functional limitation, and is calculated as the mean of each response. The change in BCTQ-FSS score at the 24-month follow-up relative to baseline.	24 Months
Numeric Pain Scale	Subjects will be asked to rate their wrist pain severity on a scale of 0 to 10, where 0 represents "no pain" and 10 represents "worst possible pain". The change in Numeric Pain Scale score at the 24-month follow-up relative to baseline.	24 Months
EuroQoL 5-Dimension 5-Level (EQ-5D-5L)	The EQ-5D-5L measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 5-level severity ranking consisting of: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. The change in EQ-5D-5L score at the 24-month follow-up relative to baseline.	24 Months
Device and/or Procedure Related Adverse Events	Incidence of device- or procedure-related AEs within 24 months of treatment.	24 Months
Global Satisfaction with Carpal Tunnel Release Procedure	Subjects will be asked to rate their satisfaction with the carpal tunnel release procedure and how likely they are to recommend their carpal tunnel release procedure to a friend or colleague on a scale from 0-10 with 0 being not at all likely and 10 being extremely likely. Satisfaction will be reported with the following options: Very Satisfied, Satisfied, Neither Satisfied or dissatisfied, Dissatisfied or Very dissatisfied.	24 Months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain medication use through 24 months	Post-index procedure use of pain medication by type (prescription [Tramadol (Ultram) or tapentadol (Nucynta) vs other prescribed opioids / narcotics], non-prescription)	24 Months
Additional surgical interventions through 24 months	Post-index CTR revision surgery by type (e.g., CTR-US, ECTR, OCTR, other) and reason (e.g., persistent symptoms, recurrent symptoms); Other post-index CTR surgery by side and surgery type (e.g., CTR, trigger finger release, trigger thumb release, release for De Quervain's syndrome, cubital tunnel	24 Months

Collaborators and Investigators

• Sponsor: Sonex Health, Inc.
• Investigators: Principal Investigator: Victor M Marwin, MD, MBA, Bluegrass Orthopaedics

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: September 26, 2023
• First Submitted That Met QC Criteria: October 4, 2023
• First Posted (Actual): October 6, 2023

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Ultrasound Guided Carpal Tunnel Release; CTR-US; OCTR; ECTR
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Peripheral Nervous System Diseases; Median Neuropathy; Mononeuropathies; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Carpal Tunnel Syndrome
• Other Study ID Numbers: 90154-TP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This study is privately funded and IPD will not be available for use beyond the study Sponsor or the participating Investigational Sites.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No