Comparison of Surgical Interventions for Lateral Epicondylitis: A Prospective Study

January 23, 2018 updated by: Christine M. Kleinert Institute for Hand and Microsurgery

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Millicent L Horn, BS
  • Phone Number: 502-562-0307
  • Email: mhorn@cmki.org

Study Contact Backup

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • Christine M. Kleinert Institute of Hand and Microsurgery
        • Contact:
          • Millicent L Horn, BS
          • Phone Number: 502-562-0307
          • Email: mhorn@cmki.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
Procedure: 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.
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.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Christine M. Kleinert Institute for Hand and Microsurgery

Investigators

  • Principal Investigator: Tuna Ozyurekoglu, MD, Christine M. Kleinert Institute of Hand and Microsurgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Anticipated)

June 1, 2019

Study Completion (Anticipated)

June 1, 2019

Study Registration Dates

First Submitted

June 11, 2012

First Submitted That Met QC Criteria

June 12, 2012

First Posted (Estimate)

June 13, 2012

Study Record Updates

Last Update Posted (Actual)

January 25, 2018

Last Update Submitted That Met QC Criteria

January 23, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11.0565

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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