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

Comparative Study of Post-Operative Outcomes of the Two-Incision Carpal Tunnel Release vs Mini-Open Carpal Tunnel Release

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.

Study Overview

• Status: Terminated
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Procedure: Mini open incision CTR

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Kleinert Kutz Hand Care Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: 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.; Other Names: Two incision CTR
Active Comparator: Two incision technique; A two-incision open carpal tunnel release techniques to ensure complete release both proximally and distally	Procedure: 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.; Other Names: Two incision CTR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resolution of carpal tunnel symptoms	Reporting 2 or less on the 0-10 pain scale, with 0 as no pain	Six weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to return to work	How long it takes the subject to return to work	Six weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
2 week post operative pain	Reported level of pain on 0-10 pain scale, with 0 as no pain	two weeks

Collaborators and Investigators

• Sponsor: University of Louisville
• Collaborators: Christine M. Kleinert Institute for Hand and Microsurgery
• Investigators: Principal Investigator: Huey Tien, MD, University of Louisville

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2022
• Primary Completion (Actual): January 3, 2023
• Study Completion (Actual): January 3, 2023

Study Registration Dates

• First Submitted: March 28, 2022
• First Submitted That Met QC Criteria: April 5, 2022
• First Posted (Actual): April 13, 2022

Study Record Updates

• Last Update Posted (Actual): August 18, 2023
• Last Update Submitted That Met QC Criteria: August 15, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Carpal Tunnel Syndrome
• Other Study ID Numbers: 21.0802

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No