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

NCT ID: NCT05325567

Last Updated: 2023-08-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-15
• Study Completion Date: 2023-01-03

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.

Detailed Description

Carpal tunnel release (CTR) is a common surgery done by hand surgeons. The aim of the procedure is to decompress the median nerve at the level of the wrist and alleviate patient symptoms that include numbness, pain and tingling sensations along the median nerve distribution. Many versions of the technique have been described, with each description claiming improvement of post-operative results and decreasing complications.

The first description of carpal tunnel release is believed to be that of Learmonth in 1933 where he describes incising the transverse carpal ligament in a lady with a wrist fracture1. Since then, the understanding towards carpal tunnel syndrome has markedly improved, and various surgical techniques have been developed.

Because carpal tunnel syndrome has become such a common condition among the population, much knowledge has been gained about carpal tunnel surgery as well. One of the easily avoided complications of the procedure is scar related morbidity and pillar pain. Bromley offered a mini-palm open carpal tunnel release technique that decompressed the median nerve while keeping the entirety of the incision distal to the wrist crease. Tsai et al and Wilson also offered two-incision open carpal tunnel release techniques in order to keep incisions small but ensure complete release both proximally and distally. Endoscopic techniques were also eventually developed with the aim of a complete release while avoiding scar related complications.

With the many options surgeons have on how to decompress the median nerve, some begin to question if techniques are being made unnecessarily complicated. Some 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.

Hypothesis:

Null hypothesis: There is no difference in post-operative outcomes between a mini-open carpal tunnel release and a two incision carpal tunnel release

Alternative hypothesis: A two-incision carpal tunnel release will yield improvement in post operative outcomes compared to that of the mini-open carpal tunnel release

Aim of the Study:

This study aims to determine whether sparing of the soft tissue structures superficial to the transverse carpal ligament will improve post-operative outcomes of patients undergoing carpal tunnel surgery.

Conditions

Carpal Tunnel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1 incision technique

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

Group Type: ACTIVE_COMPARATOR

Mini open incision CTR

Intervention Type: PROCEDURE

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

Two incision technique

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

Group Type: ACTIVE_COMPARATOR

Mini open incision CTR

Intervention Type: PROCEDURE

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

Interventions

Mini open incision CTR

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

Intervention Type: PROCEDURE

Other Intervention Names

Two incision CTR

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Christine M. Kleinert Institute for Hand and Microsurgery

OTHER

Sponsor Role: collaborator

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Huey Tien, MD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

Kleinert Kutz Hand Care Center

Louisville, Kentucky, United States

Countries

United States

Other Identifiers

21.0802

Identifier Type: -

Identifier Source: org_study_id