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

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ClinicalTrials.gov Identifier: NCT01562860
Recruitment Status : Unknown
Verified January 2018 by Christine M. Kleinert Institute for Hand and Microsurgery.
Recruitment status was:  Recruiting
First Posted : March 26, 2012
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Christine M. Kleinert Institute for Hand and Microsurgery

Study Description
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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.

Condition or disease Intervention/treatment Phase
Median Nerve Compression Procedure: Pronator Teres Release Procedure: dual compression release Procedure: median nerve release only Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Influence of Pronator Teres Release in the Treatment of Median Nerve Compression Neuropathy: A Randomized Prospective Study
Study Start Date : July 2010
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Carpal Tunnel and Pronator Teres Release
Patients enrolled in this arm of the study will have both surgical procedures performed at the same time
 Procedure: dual compression release
both procedures will be done on the same day
Active Comparator: Carpal Tunnel 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.
 Procedure: Pronator Teres Release
Surgical release of median nerve compression
Other Name: carpal tunnel release

Procedure: dual compression release
Both the carpal tunnel compression and the pronator teres compression will be released on the same day.

Procedure: median nerve release only
only the carpal tunnel compression is released


Outcome Measures
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Primary Outcome Measures :
  1. Symptom severity and functional status score (Brigham and Women's Carpal Tunnel Questionnaire) [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01562860


Contacts
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Contact: Tuna Ozyurekoglu, MD 502-561-4263 tozyurekoglu@cmki.org
Contact: Millicent L Horn, BS 502-562-0307 mhorn@cmki.org

Locations
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United States, Kentucky
Christine M. Kleinert Institute for Hand and Microsurgery Recruiting
Louisville, Kentucky, United States, 40202
Contact: Christina L Kaufman, PhD    502-562-0390    ckaufman@cmki.org   
Contact: Millicent L Horn, BS    502-562-0307    mhorn@cmki.org   
Principal Investigator: Tuna Ozyurekoglu, MD         
Sponsors and Collaborators
Christine M. Kleinert Institute for Hand and Microsurgery
Investigators
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Principal Investigator: Tuna Ozyurekoglu, MD Christine M. Kleinert Institute for Hand and Microsurgery
More Information
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Responsible Party: Christine M. Kleinert Institute for Hand and Microsurgery
ClinicalTrials.gov Identifier: NCT01562860    
Other Study ID Numbers: 10.0039
First Posted: March 26, 2012    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018
Keywords provided by Christine M. Kleinert Institute for Hand and Microsurgery:
median nerve
carpal tunnel syndrome
Pronator Teres Release
Additional relevant MeSH terms:
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Charcot-Marie-Tooth Disease
Nerve Compression Syndromes
Hereditary Sensory and Motor Neuropathy
Nervous System Malformations
Nervous System Diseases
Heredodegenerative Disorders, Nervous System
 Neurodegenerative Diseases
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Congenital Abnormalities
Genetic Diseases, Inborn