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The Effect of Surgical Incision Size on Carpal Tunnel Surgery

Primary Purpose

Carpal Tunnel Syndrome

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Carpal Tunnel Release Surgery

Carpal tunnel release surgery

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:

Patients undergoing open carpal tunnel release will be included in this study.
Patients must have clinical evidence of Carpal Tunnel Syndrome
Patients must have positive EMG results

Patient selection factors include:

Ability and willingness to follow instructions
Patients who are able and willing to return for follow-up evaluations.
Patients of all races and genders.
Patients who are able to follow care instructions.

Exclusion Criteria:

Patients less than 18 years old
Patients unwillingly or unable to comply with a rehabilitation program for carpal tunnel release who indicate difficulty or inability to return for follow-up visits prescribed by the study protocol.
Patients who qualify for inclusion in the study, but refuse consent to participate in the study.

Sites / Locations

Vanderbilt Orthopaedic Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Function questionnaires, pain assessment questionnaires, and clinical measurements will be used to determine the outcome of this study.

Secondary Outcome Measures

Full Information

NCT ID

NCT00435071

First Posted

February 12, 2007

Last Updated

February 17, 2011

Sponsor

Vanderbilt University

1. Study Identification

Unique Protocol Identification Number

NCT00435071

Brief Title

The Effect of Surgical Incision Size on Carpal Tunnel Surgery

Official Title

The Effect of Surgical Incision Size on Carpal Tunnel Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

February 2011

Overall Recruitment Status

Terminated

Why Stopped

Investigator initiated suspension to focus on other studies.

Study Start Date

December 2006 (undefined)

Primary Completion Date

June 2008 (Actual)

Study Completion Date

June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Vanderbilt University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study will investigate the postoperative recovery advantages from having a smaller incision to a larger incision.

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

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Active Comparator

Intervention Type

Procedure

Intervention Name(s)

Carpal Tunnel Release Surgery

Intervention Description

Patient will have large incision size during carpal tunnel release surgery.

Intervention Type

Procedure

Intervention Name(s)

Carpal tunnel release surgery

Intervention Description

Patient will have a small incision size during carpal tunnel release surgery.

Primary Outcome Measure Information:

Title

Function questionnaires, pain assessment questionnaires, and clinical measurements will be used to determine the outcome of this study.

Time Frame

6 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients undergoing open carpal tunnel release will be included in this study. Patients must have clinical evidence of Carpal Tunnel Syndrome Patients must have positive EMG results Patient selection factors include: Ability and willingness to follow instructions Patients who are able and willing to return for follow-up evaluations. Patients of all races and genders. Patients who are able to follow care instructions. Exclusion Criteria: Patients less than 18 years old Patients unwillingly or unable to comply with a rehabilitation program for carpal tunnel release who indicate difficulty or inability to return for follow-up visits prescribed by the study protocol. Patients who qualify for inclusion in the study, but refuse consent to participate in the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Julie Daniels

Organizational Affiliation

VUMC

Official's Role

Study Director

Facility Information:

Facility Name

Vanderbilt Orthopaedic Institute

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232-8828

Country

United States

12. IPD Sharing Statement

Learn more about this trial

The Effect of Surgical Incision Size on Carpal Tunnel Surgery

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