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Influence of Pronator Teres Release on Treatment of Median Nerve Compression Neuropathy

Primary Purpose

Median Nerve Compression

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Pronator Teres Release
dual compression release
dual compression release
median nerve release only
Sponsored by
Christine M. Kleinert Institute for Hand and Microsurgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Median Nerve Compression focused on measuring median nerve, carpal tunnel syndrome, Pronator Teres Release

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • Inclusion Criteria: Positive Tinnels signs over the median nerve at the Carpal Tunnel and Pronator Teres
  • Normal two point discrimination
  • Over the age of 18 and under the age of 65

Exclusion Criteria:

  • Peripheral neuropathy of the median nerve secondary to trauma
  • Presence of thoracic outlet syndrome
  • Presence of cervical disk disease
  • Under the age of 18 and over the age of 65

Sites / Locations

  • Christine M. Kleinert Institute for Hand and MicrosurgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Carpal Tunnel and Pronator Teres Release

Carpal Tunnel Release only

Arm Description

Patients enrolled in this arm of the study will have both surgical procedures performed at the same time

Patients enrolled in this arm will have only Carpal Tunnel Release performed. In they still have symptoms of median nerve neuropathy, they will be scheduled for an additional procedure to release the pronator Teres in a separate surgery.

Outcomes

Primary Outcome Measures

Symptom severity and functional status score (Brigham and Women's Carpal Tunnel Questionnaire)
The primary outcome measure will be the difference between the pre and post operative assessments of the questionnaire, which will represent the degree of improvement as result of the surgical intervention.

Secondary Outcome Measures

Full Information

First Posted
August 8, 2011
Last Updated
January 23, 2018
Sponsor
Christine M. Kleinert Institute for Hand and Microsurgery
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1. Study Identification

Unique Protocol Identification Number
NCT01562860
Brief Title
Influence of Pronator Teres Release on Treatment of Median Nerve Compression Neuropathy
Official Title
The Influence of Pronator Teres Release in the Treatment of Median Nerve Compression Neuropathy: A Randomized Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 2010 (undefined)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
July 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Christine M. Kleinert Institute for Hand and Microsurgery

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators are comparing two standard of care procedures which can be performed at the same time, or sequentially. The hypothesis being tested is whether simultaneous release of both the carpal Tunnel and the Pronator Teres results in a better outcome in terms of symptom relief and recurrence than Carpal Tunnel Release alone when signs and symptoms of both carpal tunnel and pronator Teres syndromes are present.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Median Nerve Compression
Keywords
median nerve, carpal tunnel syndrome, Pronator Teres Release

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Carpal Tunnel and Pronator Teres Release
Arm Type
Active Comparator
Arm Description
Patients enrolled in this arm of the study will have both surgical procedures performed at the same time
Arm Title
Carpal Tunnel Release only
Arm Type
Active Comparator
Arm Description
Patients enrolled in this arm will have only Carpal Tunnel Release performed. In they still have symptoms of median nerve neuropathy, they will be scheduled for an additional procedure to release the pronator Teres in a separate surgery.
Intervention Type
Procedure
Intervention Name(s)
Pronator Teres Release
Other Intervention Name(s)
carpal tunnel release
Intervention Description
Surgical release of median nerve compression
Intervention Type
Procedure
Intervention Name(s)
dual compression release
Intervention Description
Both the carpal tunnel compression and the pronator teres compression will be released on the same day.
Intervention Type
Procedure
Intervention Name(s)
dual compression release
Intervention Description
both procedures will be done on the same day
Intervention Type
Procedure
Intervention Name(s)
median nerve release only
Intervention Description
only the carpal tunnel compression is released
Primary Outcome Measure Information:
Title
Symptom severity and functional status score (Brigham and Women's Carpal Tunnel Questionnaire)
Description
The primary outcome measure will be the difference between the pre and post operative assessments of the questionnaire, which will represent the degree of improvement as result of the surgical intervention.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Positive Tinnels signs over the median nerve at the Carpal Tunnel and Pronator Teres Normal two point discrimination Over the age of 18 and under the age of 65 Exclusion Criteria: Peripheral neuropathy of the median nerve secondary to trauma Presence of thoracic outlet syndrome Presence of cervical disk disease Under the age of 18 and over the age of 65
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tuna Ozyurekoglu, MD
Phone
502-561-4263
Email
tozyurekoglu@cmki.org
First Name & Middle Initial & Last Name or Official Title & Degree
Millicent L Horn, BS
Phone
502-562-0307
Email
mhorn@cmki.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tuna Ozyurekoglu, MD
Organizational Affiliation
Christine M. Kleinert Institute for Hand and Microsurgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Christine M. Kleinert Institute for Hand and Microsurgery
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina L Kaufman, PhD
Phone
502-562-0390
Email
ckaufman@cmki.org
First Name & Middle Initial & Last Name & Degree
Millicent L Horn, BS
Phone
502-562-0307
Email
mhorn@cmki.org
First Name & Middle Initial & Last Name & Degree
Tuna Ozyurekoglu, MD

12. IPD Sharing Statement

Learn more about this trial

Influence of Pronator Teres Release on Treatment of Median Nerve Compression Neuropathy

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