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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
Sponsored by
Vanderbilt University
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:

  • 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:

  1. Ability and willingness to follow instructions
  2. Patients who are able and willing to return for follow-up evaluations.
  3. Patients of all races and genders.
  4. 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

Active Comparator

Arm Label

1

2

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

First Posted
February 12, 2007
Last Updated
February 17, 2011
Sponsor
Vanderbilt University
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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
No

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
1
Arm Type
Active Comparator
Arm Title
2
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
No
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

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The Effect of Surgical Incision Size on Carpal Tunnel Surgery

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