Influence of Pronator Teres Release on Treatment of Median Nerve Compression Neuropathy
The Influence of Pronator Teres Release in the Treatment of Median Nerve Compression Neuropathy: A Randomized Prospective Study
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2010
Longer than P75 for phase_2
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
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 8, 2011
CompletedFirst Posted
Study publicly available on registry
March 26, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedJanuary 25, 2018
January 1, 2018
9 years
August 8, 2011
January 23, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
12 months
Study Arms (2)
Carpal Tunnel and Pronator Teres Release
ACTIVE COMPARATORPatients enrolled in this arm of the study will have both surgical procedures performed at the same time
Carpal Tunnel Release only
ACTIVE COMPARATORPatients 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.
Interventions
Surgical release of median nerve compression
Both the carpal tunnel compression and the pronator teres compression will be released on the same day.
only the carpal tunnel compression is released
Eligibility Criteria
You may qualify if:
- Normal two point discrimination
- Over the age of 18 and under the age of 65
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Christine M. Kleinert Institute for Hand and Microsurgery
Louisville, Kentucky, 40202, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tuna Ozyurekoglu, MD
Christine M. Kleinert Institute for Hand and Microsurgery
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2011
First Posted
March 26, 2012
Study Start
July 1, 2010
Primary Completion
July 1, 2019
Study Completion
July 1, 2019
Last Updated
January 25, 2018
Record last verified: 2018-01