Trial record 10 of 35 for:    Open Studies | "Elbow"

Comparison of Surgical Interventions for Lateral Epicondylitis: A Prospective Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Christine M. Kleinert Institute for Hand and Microsurgery
Sponsor:
Information provided by (Responsible Party):
Christine M. Kleinert Institute for Hand and Microsurgery
ClinicalTrials.gov Identifier:
NCT01618487
First received: June 11, 2012
Last updated: July 9, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Lateral Epicondylitis
Tennis Elbow
Procedure: Arthroscopic tenotomy
Procedure: Open tenotomy
Procedure: Debridement and repair
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Surgical Interventions for Lateral Epicondylitis: A Randomized, Prospective Study

Resource links provided by NLM:


Further study details as provided by Christine M. Kleinert Institute for Hand and Microsurgery:

Primary Outcome Measures:
  • symptom severity and functional outcome score (Patient Rated Tennis Elbow Evaluation) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    The primary outcome measure will be the difference btetwee the pre and post operative assessments of questionnaire and symptom severity.


Estimated Enrollment: 150
Study Start Date: February 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01618487

Contacts
Contact: Tuna Ozyurekoglu, MD 502-561-4286 tozyurekoglu@kleinertkutz.com
Contact: Ross D Gibson, BA 502-562-0307 rgibson@cmki.org

Locations
United States, Kentucky
Christine M. Kleinert Institute of Hand and Microsurgery Recruiting
Louisville, Kentucky, United States, 40202
Contact: Christina L Kaufman, PhD    502-562-0390    ckaufman@cmki.org   
Contact: Ross D Gibson, BA    502-562-0307    rgibson@cmki.org   
Sponsors and Collaborators
Christine M. Kleinert Institute for Hand and Microsurgery
Investigators
Principal Investigator: Tuna Ozyurekoglu, MD Christine M. Kleinert Institute of Hand and Microsurgery
  More Information

No publications provided

Responsible Party: Christine M. Kleinert Institute for Hand and Microsurgery
ClinicalTrials.gov Identifier: NCT01618487     History of Changes
Other Study ID Numbers: 11.0565
Study First Received: June 11, 2012
Last Updated: July 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Christine M. Kleinert Institute for Hand and Microsurgery:
tennis elbow
lateral epicondylitis

Additional relevant MeSH terms:
Tennis Elbow
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on August 26, 2014