Patient Outcomes With Endoscopic Versus Open Carpal Tunnel Release
Endoscopic vs Open Carpal Tunnel Release: Comparison of Patient Satisfaction, Outcomes, and Complications
1 other identifier
interventional
38
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 23, 2009
CompletedFirst Submitted
Initial submission to the registry
April 10, 2009
CompletedFirst Posted
Study publicly available on registry
April 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 26, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 26, 2016
CompletedNovember 24, 2017
November 1, 2017
7.3 years
April 10, 2009
November 21, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Primary outcome: patient satisfaction via surveys used in prior publications
24 weeks
Study Arms (2)
endoscopic surgery
ACTIVE COMPARATORopen surgery
ACTIVE COMPARATORInterventions
endoscopic surgery, which is standard of care for carpal tunnel release
open surgery, which is standard of care for carpal tunnel release
Eligibility Criteria
You may qualify if:
- Patients between the ages of 18 and 75
- Documented clinical and electromyography (EMG) proven carpal tunnel syndrome
You may not qualify if:
- Recurrent carpal tunnel syndrome
- Inflammatory arthropathy
- Peripheral neuropathy
- Diabetes
- \< 18 or \> 75 years old
- Pregnant at the time of enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen Nogan, B.S.
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2009
First Posted
April 13, 2009
Study Start
March 23, 2009
Primary Completion
July 26, 2016
Study Completion
July 26, 2016
Last Updated
November 24, 2017
Record last verified: 2017-11