Patient Outcomes With Endoscopic Versus Open Carpal Tunnel Release

Official Title: “Endoscopic vs Open Carpal Tunnel Release: Comparison of Patient Satisfaction, Outcomes, and Complications”

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

Intervention(s) in this Clinical Trial

• Procedure: endoscopic carpal tunnel release
  • endoscopic surgery, which is standard of care for carpal tunnel release
• Procedure: open carpal tunnel release
  • open surgery, which is standard of care for carpal tunnel release

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: endoscopic surgery
• Active Comparator: open surgery

Primary Measures

• Primary outcome: patient satisfaction via surveys used in prior publications
  • Time Frame: 24 weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Penn State University Other

Overall Clinical Trial Officials and Contacts

Stephen Nogan, B.S. Principal Investigator Penn State College of Medicine, Penn State Milton S. Hershey Medical Center  

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

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00880295

Study ID Number: 24457

ClinicalTrials.gov Identifier: NCT00880295

Health Authority: United States: Institutional Review Board