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

Primary Purpose

Carpal Tunnel Syndrome

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mini open incision CTR
Sponsored by
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kleinert Kutz Hand Care Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1 incision technique

Two incision technique

Arm Description

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

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

Outcomes

Primary Outcome Measures

Resolution of carpal tunnel symptoms
Reporting 2 or less on the 0-10 pain scale, with 0 as no pain

Secondary Outcome Measures

Time to return to work
How long it takes the subject to return to work

Full Information

First Posted
March 28, 2022
Last Updated
August 15, 2023
Sponsor
University of Louisville
Collaborators
Christine M. Kleinert Institute for Hand and Microsurgery
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1. Study Identification

Unique Protocol Identification Number
NCT05325567
Brief Title
Comparative Study of Two Incision vs. Mini Open Carpal Tunnel Release
Official Title
Comparative Study of Post-Operative Outcomes of the Two-Incision Carpal Tunnel Release vs Mini-Open Carpal Tunnel Release
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
study was not renewed.
Study Start Date
June 15, 2022 (Actual)
Primary Completion Date
January 3, 2023 (Actual)
Study Completion Date
January 3, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Louisville
Collaborators
Christine M. Kleinert Institute for Hand and Microsurgery

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Investigator
Masking Description
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.
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 incision technique
Arm Type
Active Comparator
Arm Description
a mini-open incision that allows adequate exposure of the transverse carpal ligament (TCL), while staying distal to the distal wrist crease.
Arm Title
Two incision technique
Arm Type
Active Comparator
Arm Description
A two-incision open carpal tunnel release techniques to ensure complete release both proximally and distally
Intervention Type
Procedure
Intervention Name(s)
Mini open incision CTR
Other Intervention Name(s)
Two incision CTR
Intervention Description
two techniques commonly used for carpal tunnel release are being compared to determine if one vs. the other provides superior patient outcomes.
Primary Outcome Measure Information:
Title
Resolution of carpal tunnel symptoms
Description
Reporting 2 or less on the 0-10 pain scale, with 0 as no pain
Time Frame
Six weeks
Secondary Outcome Measure Information:
Title
Time to return to work
Description
How long it takes the subject to return to work
Time Frame
Six weeks
Other Pre-specified Outcome Measures:
Title
2 week post operative pain
Description
Reported level of pain on 0-10 pain scale, with 0 as no pain
Time Frame
two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huey Tien, MD
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kleinert Kutz Hand Care Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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