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Patient Outcomes With Endoscopic Versus Open Carpal Tunnel Release

NCT ID: NCT00880295

Last Updated: 2017-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-23

Study Completion Date

2016-07-26

Brief Summary

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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

Detailed Description

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Conditions

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Carpal Tunnel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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endoscopic surgery

Group Type ACTIVE_COMPARATOR

endoscopic carpal tunnel release

Intervention Type PROCEDURE

endoscopic surgery, which is standard of care for carpal tunnel release

open surgery

Group Type ACTIVE_COMPARATOR

open carpal tunnel release

Intervention Type PROCEDURE

open surgery, which is standard of care for carpal tunnel release

Interventions

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endoscopic carpal tunnel release

endoscopic surgery, which is standard of care for carpal tunnel release

Intervention Type PROCEDURE

open carpal tunnel release

open surgery, which is standard of care for carpal tunnel release

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Penn State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephen Nogan, B.S.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Hershey, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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24457

Identifier Type: -

Identifier Source: org_study_id