The Effect of Surgical Incision Size on Carpal Tunnel Surgery

This study is ongoing, but not recruiting participants.

First Received: February 12, 2007 Last Updated: April 10, 2009 History of Changes

Sponsored by:	Vanderbilt University
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00435071

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

Genetics Home Reference related topics: Charcot-Marie-Tooth disease hereditary neuropathy with liability to pressure palsies

MedlinePlus related topics: Carpal Tunnel Syndrome Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment
Official Title:	The Effect of Surgical Incision Size on Carpal Tunnel Surgery

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
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Procedure: Carpal Tunnel Release Surgery Patient will have large incision size during carpal tunnel release surgery.
2: Active Comparator	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:

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.

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:	Vanderbilt University ( Dr. Donald Lee )
Study ID Numbers:	061043
Study First Received:	February 12, 2007
Last Updated:	April 10, 2009
ClinicalTrials.gov Identifier:	NCT00435071 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Roussy Levy Hereditary Areflexic Dystasia
Carpal Tunnel Syndrome
Charcot Marie Tooth Disease
Charcot-Marie-Tooth Disease
Wounds and Injuries
Disorders of Environmental Origin
Tomaculous Neuropathy

Mononeuropathies
Nerve Compression Syndromes
Neuromuscular Diseases
Peripheral Nervous System Diseases
Hereditary Motor and Sensory Neuropathies
Cumulative Trauma Disorders
Sprains and Strains

Additional relevant MeSH terms:

Median Neuropathy
Carpal Tunnel Syndrome
Disease
Nervous System Diseases
Wounds and Injuries
Disorders of Environmental Origin
Mononeuropathies

Nerve Compression Syndromes
Pathologic Processes
Neuromuscular Diseases
Syndrome
Peripheral Nervous System Diseases
Cumulative Trauma Disorders
Sprains and Strains

ClinicalTrials.gov processed this record on May 07, 2009