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Patient Outcomes With Endoscopic Versus Open Carpal Tunnel Release

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Penn State University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Penn State University
ClinicalTrials.gov Identifier:
NCT00880295
First received: April 10, 2009
Last updated: August 4, 2010
Last verified: April 2009
History of Changes
  Purpose

Although some surgeons prefer one technique rather than the other, both endoscopic and open carpal tunnel release procedures are accepted as standard of care surgeries to relieve carpal tunnel syndrome. The investigator's research is designed to evaluate the significant difference in patient satisfaction between endoscopically-released wrists and open-released wrists. The goal of the study is to compare the two techniques using the following criteria:

  1. Primary outcome: patient satisfaction via surveys used in prior publications
  2. Secondary outcome: length of time to return to work
  3. Secondary outcome: clinical data for recovery from carpal tunnel syndrome including a thorough physical exam and EMG's
  4. Secondary outcome: complication rates

Condition Intervention Phase
Carpal Tunnel Syndrome
 Procedure: endoscopic carpal tunnel release
Procedure: open carpal tunnel release
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Endoscopic vs Open Carpal Tunnel Release: Comparison of Patient Satisfaction, Outcomes, and Complications

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Penn State University:

Primary Outcome Measures:
  • Primary outcome: patient satisfaction via surveys used in prior publications [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 68
Arms Assigned Interventions
Active Comparator: endoscopic surgery Procedure: endoscopic carpal tunnel release
endoscopic surgery, which is standard of care for carpal tunnel release
Active Comparator: open surgery Procedure: open carpal tunnel release
open surgery, which is standard of care for carpal tunnel release

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients between the ages of 18 and 75
  2. Documented clinical and electromyography (EMG) proven carpal tunnel syndrome

Exclusion Criteria:

  1. Recurrent carpal tunnel syndrome
  2. Inflammatory arthropathy
  3. Peripheral neuropathy
  4. Diabetes
  5. < 18 or > 75 years old
  6. Pregnant at the time of enrollment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00880295

Contacts
Contact: Randy Hauck, M.D. 7175314340 rhauck@hmc.psu.edu

Locations
United States, Pennsylvania
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Hauck         rhauck@hmc.psu.edu    
Sponsors and Collaborators
Penn State University
Investigators
Principal Investigator: Stephen Nogan, B.S. Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
  More Information

No publications provided

Responsible Party: Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00880295     History of Changes
Other Study ID Numbers: 24457
Study First Received: April 10, 2009
Last Updated: August 4, 2010
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 18, 2013