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Comparison of Surgical Interventions for Lateral Epicondylitis: A Prospective Study

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01618487
Enrollment
150
Registered
2012-06-13
Start date
2012-02-29
Completion date
2019-06-30
Last updated
2018-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lateral Epicondylitis, Tennis Elbow

Keywords

tennis elbow, lateral epicondylitis

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.

Interventions

PROCEDUREArthroscopic tenotomy

This is a surgical procedure where small incisions are made and a scope is used to see the tendon and release it.

PROCEDUREOpen tenotomy

This involves opening the skin on the arm up to expose the muscle and tendon. There is a total of 1 incision made.

PROCEDUREDebridement 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.

Sponsors

Christine M. Kleinert Institute for Hand and Microsurgery
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
symptom severity and functional outcome score (Patient Rated Tennis Elbow Evaluation)24 monthsThe primary outcome measure will be the difference btetwee the pre and post operative assessments of questionnaire and symptom severity.

Countries

United States

Contacts

Primary ContactTuna Ozyurekoglu, MD
tozyurekoglu@kleinertkutz.com502-561-4286
Backup ContactMillicent L Horn, BS
mhorn@cmki.org502-562-0307

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026