Recruiting
Phase 2

Tenotomy vs. Debridement

Sponsor:

Christine M. Kleinert Institute for Hand and Microsurgery

Code:

NCT01618487

Conditions

Lateral Epicondylitis

Tennis Elbow

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Arthroscopic tenotomy

Open tenotomy

Debridement and repair

Study Details

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.

Conditions

Lateral Epicondylitis

Tennis Elbow

Study ID

NCT01618487

Start date

Feb, 2012

Status verified date

Jan, 2018

Completion date

Jun, 2019

Anticipated

Primary completion date

Jun, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

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.

Interventions

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.

Primary outcome measure

  • symptom severity and functional outcome score (Patient Rated Tennis Elbow Evaluation) [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Tuna Ozyurekoglu, MD

502-561-4286tozyurekoglu@kleinertkutz.com

Millicent L Horn, BS

502-562-0307mhorn@cmki.org

Locations

Christine M. Kleinert Institute of Hand and Microsurgery

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Christina L Kaufman, PhD

502-562-0390ckaufman@cmki.org

Millicent L Horn, BS

502-562-0307mhorn@cmki.org

More Information

Sponsor

Christine M. Kleinert Institute for Hand and Microsurgery

Last update posted

Jan 25, 2018

Last verified

Jan, 2018

Keywords

  • tennis elbow
  • lateral epicondylitis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Christine M. Kleinert Institute for Hand and Microsurgery on 2018-01-25.