Comparison of Surgical Interventions for Lateral Epicondylitis: A Prospective Study

Lateral Epicondylitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01618487
• Other study ID #: 11.0565
• Status: Recruiting
• Phase: Phase 2
• First received: June 11, 2012
• Last updated: January 23, 2018
• Start date: February 2012
• Est. completion date: June 2019

Study information

• Verified date: January 2018
• Source: Christine M. Kleinert Institute for Hand and Microsurgery
• Contact: Tuna Ozyurekoglu, MD
• Phone: 502-561-4286
• Email: tozyurekoglu[@]kleinertkutz.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Lateral Epicondylitis
• Tennis Elbow

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Christine M. Kleinert Institute of Hand and Microsurgery	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Christine M. Kleinert Institute for Hand and Microsurgery

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	symptom severity and functional outcome score (Patient Rated Tennis Elbow Evaluation)	The primary outcome measure will be the difference btetwee the pre and post operative assessments of questionnaire and symptom severity.	24 months