Comparison of Surgical Interventions for Lateral Epicondylitis: A Prospective Study

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Surgical Interventions for Lateral Epicondylitis: A Randomized, Prospective Study

Conditions
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Lateral Epicondylitis, Tennis Elbow

Intervention / Treatment
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* Procedure: Arthroscopic tenotomy
* Procedure: Open tenotomy
* Procedure: Debridement and repair


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arthroscopic tenotomy<br>Patients who are in this group will have arthroscopic tenotomy. A scope is used to see the tendon and release it. | Procedure: Arthroscopic tenotomy<br>* This is a surgical procedure where small incisions are made and a scope is used to see the tendon and release it.<br>|
| Active Comparator: Open tenotomy<br>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<br>* This involves opening the skin on the arm up to expose the muscle and tendon. There is a total of 1 incision made.<br>|
| Active Comparator: Debridement and repair<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptom severity and functional outcome score (Patient Rated Tennis Elbow Evaluation) | The primary outcome measure will be the difference btetwee the pre and post operative assessments of questionnaire and symptom severity. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tennis elbow, lateral epicondylitis