The Effect of Surgical Incision Size on Carpal Tunnel Surgery

Carpal Tunnel Syndrome Clinical Trial

Official title:

The Effect of Surgical Incision Size on Carpal Tunnel Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00435071
• Other study ID #: 061043
• Status: Terminated
• Phase: N/A
• First received: February 12, 2007
• Last updated: February 17, 2011
• Start date: December 2006
• Est. completion date: June 2008

Study information

• Verified date: February 2011
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome

Intervention

Procedure:
• Carpal Tunnel Release Surgery
Patient will have large incision size during carpal tunnel release surgery.
• Carpal tunnel release surgery
Patient will have a small incision size during carpal tunnel release surgery.

Locations

Country	Name	City	State
United States	Vanderbilt Orthopaedic Institute	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Function questionnaires, pain assessment questionnaires, and clinical measurements will be used to determine the outcome of this study.		6 month	No