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

Phase 2

• Conditions: Median Nerve Compression
• Interventions: Procedure: Pronator Teres Release; Procedure: dual compression release; Procedure: median nerve release only

• Registration Number: NCT01562860
• Lead Sponsor: Christine M. Kleinert Institute for Hand and Microsurgery

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2011-08-08
• Study First Submitted QC: 2012-03-22
• Study First Posted: 2012-03-26
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-23
• Last Update Posted: 2018-01-25
• Primary Completion: 2019-07
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carpal Tunnel Release only	Pronator Teres Release	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.
Carpal Tunnel Release only	dual compression release	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.
Carpal Tunnel and Pronator Teres Release	dual compression release	Patients enrolled in this arm of the study will have both surgical procedures performed at the same time
Carpal Tunnel Release only	median nerve release only	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.

Primary Outcome Measures

Name	Time	Method
Symptom severity and functional status score (Brigham and Women's Carpal Tunnel Questionnaire)	12 months	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.

Trial Locations

Locations (1)

Christine M. Kleinert Institute for Hand and Microsurgery; 🇺🇸 Louisville, Kentucky, United States