Comparative Study of Two Incision vs. Mini Open Carpal Tunnel Release

NCT05325567 | Terminated

• 1 other identifier: 21.0802
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Hand surgeons have many options to perform carpal tunnel release surgery. Some surgeons believe that techniques are best kept simple: a mini-open incision that allows adequate exposure of the transverse carpal ligament (TCL), while staying distal to the distal wrist crease will offer good outcomes. Others feel that as a minimally invasive technique, it is integral to spare the soft tissue structures superficial to the TCL. This study aims to determine whether sparing these superficial structures indeed improves patient outcomes, compared to a conventional two incision approach.

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

• Resolution of carpal tunnel symptoms

  Reporting 2 or less on the 0-10 pain scale, with 0 as no pain

  Six weeks

Secondary Outcomes (1)

• Time to return to work

  Six weeks

Other Outcomes (1)

• 2 week post operative pain

  two weeks

Study Arms (2)

1 incision technique

ACTIVE COMPARATOR

a mini-open incision that allows adequate exposure of the transverse carpal ligament (TCL), while staying distal to the distal wrist crease.

Procedure: Mini open incision CTR

Two incision technique

ACTIVE COMPARATOR

A two-incision open carpal tunnel release techniques to ensure complete release both proximally and distally

Procedure: Mini open incision CTR

Interventions

Mini open incision CTR PROCEDURE

two techniques commonly used for carpal tunnel release are being compared to determine if one vs. the other provides superior patient outcomes.

Also known as: Two incision CTR

1 incision technique; Two incision technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants over the age of 18
• Patients who have not undergone any prior wrist surgery that may alter the native wrist anatomy
• Participants surgery must only be carpal tunnel release (no trigger fingers, de quervain release, etc.)
• Participants must have read and understood the consent form for the performance of the procedure and enrollment into the study. Consent must be signed in front of the principal investigator and a witness

You may not qualify if:

• Patients who are under the age of 18
• Patients who had other major surgery on the extremity being assessed potentially altering the native anatomy of the volar wrist area
• Patients who plan to have multiple hand procedures done along with their carpal tunnel release
• Patients refusing to sign the consent and enrollment form for the study

Sponsors & Collaborators

• University of Louisville: lead
• Christine M. Kleinert Institute for Hand and Microsurgery: collaborator

Study Sites (1)

Kleinert Kutz Hand Care Center

Louisville, Kentucky, 40202, United States

Location

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

• Huey Tien, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Patients will be scheduled and added to the operative list of the day by the PI's primary nurse. The primary nurse is not a part of the study and will not be present in the operating room. On the day of surgery, all enrolled patients who happen to be in the list in an odd number will undergo 1 incision technique while those on the list who are in an even number will undergo 2 incision technique.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: On the day of surgery, all enrolled patients who happen to be in the list in an odd number will undergo 1 incision technique while those on the list who are in an even number will undergo 2 incision technique.

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 13, 2022
• Study Start: June 15, 2022
• Primary Completion: January 3, 2023
• Study Completion: January 3, 2023
• Last Updated: August 18, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)