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Patient Outcomes With Endoscopic Versus Open Carpal Tunnel Release

Primary Purpose

Carpal Tunnel Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
endoscopic carpal tunnel release
open carpal tunnel release
Sponsored by
Penn State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

endoscopic surgery

open surgery

Arm Description

Outcomes

Primary Outcome Measures

Primary outcome: patient satisfaction via surveys used in prior publications

Secondary Outcome Measures

Full Information

First Posted
April 10, 2009
Last Updated
November 21, 2017
Sponsor
Penn State University
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1. Study Identification

Unique Protocol Identification Number
NCT00880295
Brief Title
Patient Outcomes With Endoscopic Versus Open Carpal Tunnel Release
Official Title
Endoscopic vs Open Carpal Tunnel Release: Comparison of Patient Satisfaction, Outcomes, and Complications
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
March 23, 2009 (Actual)
Primary Completion Date
July 26, 2016 (Actual)
Study Completion Date
July 26, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Penn State University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
endoscopic surgery
Arm Type
Active Comparator
Arm Title
open surgery
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
endoscopic carpal tunnel release
Intervention Description
endoscopic surgery, which is standard of care for carpal tunnel release
Intervention Type
Procedure
Intervention Name(s)
open carpal tunnel release
Intervention Description
open surgery, which is standard of care for carpal tunnel release
Primary Outcome Measure Information:
Title
Primary outcome: patient satisfaction via surveys used in prior publications
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients between the ages of 18 and 75 Documented clinical and electromyography (EMG) proven carpal tunnel syndrome Exclusion Criteria: Recurrent carpal tunnel syndrome Inflammatory arthropathy Peripheral neuropathy Diabetes < 18 or > 75 years old Pregnant at the time of enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Nogan, B.S.
Organizational Affiliation
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

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Patient Outcomes With Endoscopic Versus Open Carpal Tunnel Release

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