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Patient Outcomes With Endoscopic Versus Open Carpal Tunnel Release

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ClinicalTrials.gov Identifier: NCT00880295
Recruitment Status : Completed
First Posted : April 13, 2009
Last Update Posted : November 24, 2017
Sponsor:
Information provided by (Responsible Party):
Penn State University

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

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Procedure: endoscopic carpal tunnel release Procedure: open carpal tunnel release Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Endoscopic vs Open Carpal Tunnel Release: Comparison of Patient Satisfaction, Outcomes, and Complications
Actual Study Start Date : March 23, 2009
Actual Primary Completion Date : July 26, 2016
Actual Study Completion Date : July 26, 2016


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Primary outcome: patient satisfaction via surveys used in prior publications [ Time Frame: 24 weeks ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00880295


Locations
United States, Pennsylvania
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
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

Responsible Party: Penn State University
ClinicalTrials.gov Identifier: NCT00880295     History of Changes
Other Study ID Numbers: 24457
First Posted: April 13, 2009    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017

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