Comparison of Surgical Interventions for Lateral Epicondylitis: A Prospective Study

Christine M. Kleinert Institute for Hand and Microsurgery

Status and phase: Unknown; Phase 2

Conditions: Tennis Elbow; Lateral Epicondylitis

Treatments: Procedure: Arthroscopic tenotomy; Procedure: Open tenotomy; Procedure: Debridement and repair

Study type: Interventional

Funder types: Other

Identifiers

NCT01618487

11.0565

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Arthroscopic tenotomy

Active Comparator group

Description:

Patients who are in this group will have arthroscopic tenotomy. A scope is used to see the tendon and release it.

Treatment:

Procedure: Arthroscopic tenotomy

Open tenotomy

Active Comparator group

Description:

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.

Treatment:

Procedure: Open tenotomy

Debridement and repair

Active Comparator group

Description:

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.

Treatment:

Procedure: Debridement and repair