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Comparison of Surgical Interventions for Lateral Epicondylitis: A Prospective Study

This study is currently recruiting participants.
Verified January 2013 by Christine M. Kleinert Institute for Hand and Microsurgery
Sponsor:
Information provided by (Responsible Party):
Christine M. Kleinert Institute for Hand and Microsurgery
ClinicalTrials.gov Identifier:
NCT01618487
First received: June 11, 2012
Last updated: January 30, 2013
Last verified: January 2013
History of Changes

June 11, 2012
January 30, 2013
February 2012
June 2016   (final data collection date for primary outcome measure)
symptom severity and functional outcome score (Patient Rated Tennis Elbow Evaluation) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
The primary outcome measure will be the difference btetwee the pre and post operative assessments of questionnaire and symptom severity.
Same as current
Complete list of historical versions of study NCT01618487 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Comparison of Surgical Interventions for Lateral Epicondylitis: A Prospective Study
Comparison of Surgical Interventions for Lateral Epicondylitis: A Randomized, Prospective Study

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Lateral Epicondylitis
  • Tennis Elbow
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
June 2016
June 2016   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Tuna Ozyurekoglu, MD 502-561-4286 tozyurekoglu@kleinertkutz.com
Contact: Rebecca E Jones, BA 502-562-0307 rjones@cmki.org
United States
 
NCT01618487
11.0565
No
Christine M. Kleinert Institute for Hand and Microsurgery
Christine M. Kleinert Institute for Hand and Microsurgery
Not Provided
Principal Investigator: Tuna Ozyurekoglu, MD Christine M. Kleinert Institute of Hand and Microsurgery
Christine M. Kleinert Institute for Hand and Microsurgery
January 2013

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