Comparison of Surgical Interventions for Lateral Epicondylitis: A Prospective Study

Phase 2

• Conditions: Tennis Elbow; Lateral Epicondylitis
• Interventions: Procedure: Open tenotomy; Procedure: Arthroscopic tenotomy; Procedure: Debridement and repair

• Registration Number: NCT01618487
• Lead Sponsor: Christine M. Kleinert Institute for Hand and Microsurgery

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-06-11
• Study First Submitted QC: 2012-06-12
• Study First Posted: 2012-06-13
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-23
• Last Update Posted: 2018-01-25
• Primary Completion: 2019-06
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Open tenotomy	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.
Arthroscopic tenotomy	Arthroscopic tenotomy	Patients who are in this group will have arthroscopic tenotomy. A scope is used to see the tendon and release it.
Debridement and repair	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.

Primary Outcome Measures

Name	Time	Method
symptom severity and functional outcome score (Patient Rated Tennis Elbow Evaluation)	24 months	The primary outcome measure will be the difference btetwee the pre and post operative assessments of questionnaire and symptom severity.

Trial Locations

Locations (1)

Christine M. Kleinert Institute of Hand and Microsurgery; 🇺🇸 Louisville, Kentucky, United States