Comparison of Surgical Interventions for Lateral Epicondylitis: A Prospective Study
|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. Read our disclaimer for details.|
|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
|Condition or disease||Intervention/treatment||Phase|
|Lateral Epicondylitis Tennis Elbow||Procedure: Arthroscopic tenotomy Procedure: Open tenotomy Procedure: Debridement and repair||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
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
|Contact: Tuna Ozyurekoglu, MDfirstname.lastname@example.org|
|Contact: Millicent L Horn, BSemail@example.com|
|Principal Investigator:||Tuna Ozyurekoglu, MD||Christine M. Kleinert Institute of Hand and Microsurgery|