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Comparison of Surgical Interventions for Lateral Epicondylitis: A Prospective Study

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ClinicalTrials.gov Identifier: NCT01618487
Recruitment Status : Unknown
Verified January 2018 by Christine M. Kleinert Institute for Hand and Microsurgery.
Recruitment status was:  Recruiting
First Posted : June 13, 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 June 11, 2012
First Posted Date  ICMJE June 13, 2012
Last Update Posted Date January 25, 2018
Study Start Date  ICMJE February 2012
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2012)
symptom severity and functional outcome score (Patient Rated Tennis Elbow Evaluation) [ Time Frame: 24 months ]
The primary outcome measure will be the difference btetwee the pre and post operative assessments of questionnaire and symptom severity.
Original Primary Outcome Measures  ICMJE Same as current
Change History
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 Comparison of Surgical Interventions for Lateral Epicondylitis: A Prospective Study
Official Title  ICMJE Comparison of Surgical Interventions for Lateral Epicondylitis: A Randomized, Prospective Study
Brief Summary The investigator hopes to determine if one of three current standard of care surgeries for lateral epicondylitis (tennis elbow) is more effective than others. The three surgeries are: arthroscopic tenotomy, open tenotomy, and debridement and repair.
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
  • Lateral Epicondylitis
  • Tennis Elbow
Intervention  ICMJE
  • Procedure: Arthroscopic tenotomy
    This is a surgical procedure where small incisions are made and a scope is used to see the tendon and release it.
  • Procedure: Open tenotomy
    This involves opening the skin on the arm up to expose the muscle and tendon. There is a total of 1 incision made.
  • Procedure: Debridement and repair
    This involves using an arthroscopic technique (using a scope and a small incision) to go in and remove any tissue that is diseased/does not belong and repairing the tear(s) in the tendon. There is a total of 1-2 incisions made.
Study Arms  ICMJE
  • Active Comparator: Arthroscopic tenotomy
    Patients who are in this group will have arthroscopic tenotomy. A scope is used to see the tendon and release it.
    Intervention: Procedure: Arthroscopic tenotomy
  • Active Comparator: Open tenotomy
    Patients in this group will undergo open tenotomy. This involves opening the skin to expose the muscle and tendon, and then the tendon is released.
    Intervention: Procedure: Open tenotomy
  • Active Comparator: Debridement and repair
    The patients in this group will undergo an arthroscopic technique (scope and small incision) to go in and remove any tissue that is diseased/does not belong and repair the tear(s) in the tendon.
    Intervention: Procedure: Debridement and repair
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 12, 2012)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18-65 yrs old
  • pain over the lateral epicondyle (via palpitation over the lateral epicondyle, resisted wrist extension, resisted finger extension of the middle finger) for a duration of greater than 6 months prior to enrollment
  • conservative treatment has failed and surgical intervention is recommend as standard of care
  • ability to give informed consent

Exclusion Criteria:

  • had surgery by a physician or specialist within the last 2 years as treatment for lateral epicondylitis
  • congenital deformities, tendon ruptures or elbow fractures within the past year
  • co-existing elbow diagnosis (i.e. osteoarthritis or instability)
  • pregnant women, women trying to get pregnant, or breastfeeding mothers
  • under the age of 18 or over 65
  • incapable of giving informed consent
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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01618487
Other Study ID Numbers  ICMJE 11.0565
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 of 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