Registry of the Patient Experience for Carpal Tunnel Release

RecruitingOBSERVATIONAL
Enrollment

2,000

Participants

Timeline

Start Date

January 26, 2024

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2027

Conditions
Carpal Tunnel SyndromeCTS
Interventions
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.

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.~1. 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.~2. 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.~3. A camera attached to a narrow tube (endoscope) is inserted into the carpal tunnel.~4. The transverse carpal ligament (which forms the roof of the carpal tunnel) is identified.~5. Using specialized cutting instruments and endoscopic guidance, the surgeon transects the TCL.~6. Endoscopic visualization and/or probing are used to confirm a complete release.~7. The wound(s) is/are typically closed with sutures."

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.~1. Following the delivery of anesthesia, an incision is made in the palm directly over the carpal tunnel.~2. The surgeon cuts through the palmar fascia to identify the TCL.~3. The surgeon transects the TCL with a scalpel and/or similar cutting instruments.~4. The surgeon inspects the carpal tunnel to ensure proper decompression.~5. The wound is closed with sutures."

Trial Locations (37)

14226

ACTIVE_NOT_RECRUITING

Buffalo Surgery Center (CTR-US), Amherst

16335

ACTIVE_NOT_RECRUITING

Meadville Medical Center (ECTR), Meadville

16801

ACTIVE_NOT_RECRUITING

University Orthopedics Center (OCTR), State College

27609

RECRUITING

The Bone&Joint Surgery Clinic (CTR-US), Raleigh

29526

ACTIVE_NOT_RECRUITING

Ortho SC (CTR-US), Conway

29615

ACTIVE_NOT_RECRUITING

Prisma Health (ECTR), Greenville

32547

RECRUITING

Orthopaedic Associates (CTR-US), Fort Walton Beach

32607

WITHDRAWN

The Orthopaedic Institute (CTR-US), Gainesville

32935

ACTIVE_NOT_RECRUITING

Melbourne Hand Center (OCTR), Melbourne

33014

ACTIVE_NOT_RECRUITING

The Orthopaedic Hand and Arm Center (CTR-US), Miami Lakes

33133

ACTIVE_NOT_RECRUITING

Miami Hand Center (NHVP), Miami

33180

ACTIVE_NOT_RECRUITING

Aventura Hand Center (CTR-US), Aventura

36535

ACTIVE_NOT_RECRUITING

The Orthopaedic Group P.C. (CTR-US), Foley

38305

ACTIVE_NOT_RECRUITING

Sports Orthopedics & Spine (CTR-US), Jackson

39202

ACTIVE_NOT_RECRUITING

Mississippi Sports Medicine& Orthopedic Center (ECTR), Jackson

40509

RECRUITING

Bluegrass Orthopaedics (CTR-US), Lexington

47715

RECRUITING

Tri-State Orthopaedics (CTR-US), Evansville

48080

ACTIVE_NOT_RECRUITING

Mendelson Orthopedic PC (CTR-US), Troy

55435

ACTIVE_NOT_RECRUITING

Twin Cities Orthopedics (OCTR), Edina

62526

WITHDRAWN

JMS Hand Associates (CTR-US), Decatur

63131

ACTIVE_NOT_RECRUITING

Orthopedic Asociates (CTR-US), St Louis

73112

WITHDRAWN

Integris Health (CTR-US), Oklahoma City

74137

ACTIVE_NOT_RECRUITING

Central Florida Orthopaedic Surgery Associates, P.L (CTR-US), Lakeland

WITHDRAWN

Northeast Oklahoma Hand and Upper Extremity Surgery (CTR-US), Tulsa

76210

ACTIVE_NOT_RECRUITING

North Texas Hand Center (CTR-US), Denton

76244

TERMINATED

North Texas Orthopedics and Spine Center (CTR-US), Fort Worth

85260

ACTIVE_NOT_RECRUITING

Phoenix Hand (CTR-US), Scottsdale

87110

ACTIVE_NOT_RECRUITING

New Mexico Orthopedics (CTR-US), Albuquerque

89123

ACTIVE_NOT_RECRUITING

Hand Center of Nevada (CTR-US), Las Vegas

97401

ACTIVE_NOT_RECRUITING

Slocum Research & Education Foundation (ECTR), Eugene

97701

ACTIVE_NOT_RECRUITING

The Center (ECTR), Bend

06033

ACTIVE_NOT_RECRUITING

Orthopaedics Associates of Hartford (OCTR), Glastonbury

02601-3825

ACTIVE_NOT_RECRUITING

Cape Cod Orthopaedics (CTR-US), Hyannis

01801

ACTIVE_NOT_RECRUITING

Excel Orthopaedic Specialists (CTR-US), Woburn

03756

ACTIVE_NOT_RECRUITING

Dartmouth Hitchcock Clinic (ECTR), Lebanon

03079

ACTIVE_NOT_RECRUITING

Mobility Bone and Joint Institute (CTR-US), Salem

02914

ACTIVE_NOT_RECRUITING

University Orthopedics, Inc.(OCTR), East Providence

All Listed Sponsors
lead

Sonex Health, Inc.

INDUSTRY