Patient Outcomes With Endoscopic Versus Open Carpal Tunnel Release

Carpal Tunnel Syndrome Clinical Trial

Official title:

Endoscopic vs Open Carpal Tunnel Release: Comparison of Patient Satisfaction, Outcomes, and Complications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00880295
• Other study ID #: 24457
• Status: Completed
• Phase: N/A
• First received: April 10, 2009
• Last updated: November 21, 2017
• Start date: March 23, 2009
• Est. completion date: July 26, 2016

Study information

• Verified date: November 2017
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: July 26, 2016
• Est. primary completion date: July 26, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	Penn State College of Medicine, Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary outcome: patient satisfaction via surveys used in prior publications		24 weeks