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Comparison of Surgical Interventions for Lateral Epicondylitis: A Prospective Study

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ClinicalTrials.gov Identifier: NCT01618487
Recruitment Status : 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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Lateral Epicondylitis Tennis Elbow Procedure: Arthroscopic tenotomy Procedure: Open tenotomy Procedure: Debridement and repair Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Surgical Interventions for Lateral Epicondylitis: A Randomized, Prospective Study
Study Start Date : February 2012
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

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Arms and Interventions
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Arm Intervention/treatment
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.
 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.
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.
 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.
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


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:

  • 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
Contacts and Locations
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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): NCT01618487


Contacts
Contact: Tuna Ozyurekoglu, MD 502-561-4286 tozyurekoglu@kleinertkutz.com
Contact: Millicent L Horn, BS 502-562-0307 mhorn@cmki.org

Locations
United States, Kentucky
Christine M. Kleinert Institute of 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   
Sponsors and Collaborators
Christine M. Kleinert Institute for Hand and Microsurgery
Investigators
Principal Investigator: Tuna Ozyurekoglu, MD Christine M. Kleinert Institute of Hand and Microsurgery
More Information
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Responsible Party: Christine M. Kleinert Institute for Hand and Microsurgery
ClinicalTrials.gov Identifier: NCT01618487     History of Changes
Other Study ID Numbers: 11.0565
First Posted: June 13, 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:
tennis elbow
lateral epicondylitis

Additional relevant MeSH terms:
Tennis Elbow
Elbow Tendinopathy
Tendinopathy
Muscular Diseases
 Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries