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The Effect of Surgical Incision Size on Carpal Tunnel Surgery

This study has been terminated.
(Investigator initiated suspension to focus on other studies.)
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00435071
First received: February 12, 2007
Last updated: February 17, 2011
Last verified: February 2011
History of Changes
  Purpose

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


Condition Intervention
Carpal Tunnel Syndrome
 Procedure: Carpal Tunnel Release Surgery
Procedure: Carpal tunnel release surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Surgical Incision Size on Carpal Tunnel Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Function questionnaires, pain assessment questionnaires, and clinical measurements will be used to determine the outcome of this study. [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: December 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Procedure: Carpal Tunnel Release Surgery
Patient will have large incision size during carpal tunnel release surgery.
Active Comparator: 2 Procedure: Carpal tunnel release surgery
Patient will have a small incision size during carpal tunnel release surgery.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00435071

Locations
United States, Tennessee
Vanderbilt Orthopaedic Institute
Nashville, Tennessee, United States, 37232-8828
Sponsors and Collaborators
Vanderbilt University
Investigators
Study Director: Julie Daniels VUMC
  More Information

No publications provided

Responsible Party: Dr. Donald Lee, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00435071     History of Changes
Other Study ID Numbers: 061043
Study First Received: February 12, 2007
Last Updated: February 17, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carpal Tunnel Syndrome
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
 Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries

ClinicalTrials.gov processed this record on June 17, 2013