Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01562860
Recruitment Status : 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

Tracking Information
First Submitted Date  ICMJE August 8, 2011
First Posted Date  ICMJE March 26, 2012
Last Update Posted Date January 25, 2018
Study Start Date  ICMJE July 2010
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01562860 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Influence of Pronator Teres Release on Treatment of Median Nerve Compression Neuropathy
Official Title  ICMJE The Influence of Pronator Teres Release in the Treatment of Median Nerve Compression Neuropathy: A Randomized Prospective Study
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Median Nerve Compression
Intervention  ICMJE
  • 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: dual compression release
    both procedures will be done on the same day
  • Procedure: median nerve release only
    only the carpal tunnel compression is released
Study Arms  ICMJE
  • 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
    Intervention: Procedure: dual compression release
  • 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.
    Interventions:
    • Procedure: Pronator Teres Release
    • Procedure: dual compression release
    • Procedure: median nerve release only
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 22, 2012)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2019
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tuna Ozyurekoglu, MD 502-561-4263 tozyurekoglu@cmki.org
Contact: Millicent L Horn, BS 502-562-0307 mhorn@cmki.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01562860
Other Study ID Numbers  ICMJE 10.0039
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Christine M. Kleinert Institute for Hand and Microsurgery
Study Sponsor  ICMJE Christine M. Kleinert Institute for Hand and Microsurgery
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tuna Ozyurekoglu, MD Christine M. Kleinert Institute for Hand and Microsurgery
PRS Account Christine M. Kleinert Institute for Hand and Microsurgery
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP