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Trial record 3 of 86 for:
Lateral Epicondylitis
Comparison of Surgical Interventions for Lateral Epicondylitis: A Prospective Study
This study is currently recruiting participants.
Verified April 2016 by Christine M. Kleinert Institute for Hand and Microsurgery
Sponsor:
Christine M. Kleinert Institute for Hand and Microsurgery
Information provided by (Responsible Party):
Christine M. Kleinert Institute for Hand and Microsurgery
ClinicalTrials.gov Identifier:
NCT01618487
First received: June 11, 2012
Last updated: April 14, 2016
Last verified: April 2016
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Lateral Epicondylitis Tennis Elbow | Procedure: Arthroscopic tenotomy Procedure: Open tenotomy Procedure: Debridement and repair | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Comparison of Surgical Interventions for Lateral Epicondylitis: A Randomized, Prospective Study |
Resource links provided by NLM:
Further study details as provided by Christine M. Kleinert Institute for Hand and Microsurgery:
Primary Outcome Measures:
- 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.
| Estimated Enrollment: | 150 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | June 2017 |
| Estimated Primary Completion Date: | June 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01618487
Please refer to this study by its ClinicalTrials.gov identifier: 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
| Responsible Party: | Christine M. Kleinert Institute for Hand and Microsurgery |
| ClinicalTrials.gov Identifier: | NCT01618487 History of Changes |
| Other Study ID Numbers: |
11.0565 |
| Study First Received: | June 11, 2012 |
| Last Updated: | April 14, 2016 |
Keywords provided by Christine M. Kleinert Institute for Hand and Microsurgery:
|
tennis elbow lateral epicondylitis |
Additional relevant MeSH terms:
|
Tennis Elbow Musculoskeletal Diseases Arm Injuries Wounds and Injuries |
ClinicalTrials.gov processed this record on July 24, 2017