Comparison of Surgical Interventions for Lateral Epicondylitis: A Prospective Study
NCT ID: NCT01618487
Last Updated: 2018-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
150 participants
INTERVENTIONAL
2012-02-29
2019-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arthroscopic tenotomy
Patients who are in this group will have arthroscopic tenotomy. A scope is used to see the tendon and release it.
Arthroscopic tenotomy
This is a surgical procedure where small incisions are made and a scope is used to see the tendon and release it.
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.
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.
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.
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.
Interventions
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Arthroscopic tenotomy
This is a surgical procedure where small incisions are made and a scope is used to see the tendon and release it.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Christine M. Kleinert Institute for Hand and Microsurgery
OTHER
Responsible Party
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Principal Investigators
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Tuna Ozyurekoglu, MD
Role: PRINCIPAL_INVESTIGATOR
Christine M. Kleinert Institute of Hand and Microsurgery
Locations
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Christine M. Kleinert Institute of Hand and Microsurgery
Louisville, Kentucky, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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11.0565
Identifier Type: -
Identifier Source: org_study_id
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