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Comparison of Surgical Interventions for Lateral Epicondylitis: A Prospective Study

Primary Purpose

Lateral Epicondylitis, Tennis Elbow

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Arthroscopic tenotomy

Open tenotomy

Debridement and repair

About this trial

This is an interventional treatment trial for Lateral Epicondylitis focused on measuring tennis elbow, lateral epicondylitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Christine M. Kleinert Institute of Hand and MicrosurgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Arthroscopic tenotomy

Open tenotomy

Debridement and repair

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01618487

First Posted

June 11, 2012

Last Updated

January 23, 2018

Sponsor

Christine M. Kleinert Institute for Hand and Microsurgery

1. Study Identification

Unique Protocol Identification Number

NCT01618487

Brief Title

Comparison of Surgical Interventions for Lateral Epicondylitis: A Prospective Study

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Unknown status

Study Start Date

February 2012 (undefined)

Primary Completion Date

June 2019 (Anticipated)

Study Completion Date

June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Christine M. Kleinert Institute for Hand and Microsurgery

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lateral Epicondylitis, Tennis Elbow

Keywords

tennis elbow, lateral epicondylitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arthroscopic tenotomy

Arm Type

Active Comparator

Arm Description

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

Arm Title

Open tenotomy

Arm Type

Active Comparator

Arm 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.

Arm Title

Debridement and repair

Arm Type

Active Comparator

Arm 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.

Intervention Type

Procedure

Intervention Name(s)

Arthroscopic tenotomy

Intervention Description

This is a surgical procedure where small incisions are made and a scope is used to see the tendon and release it.

Intervention Type

Procedure

Intervention Name(s)

Open tenotomy

Intervention Description

This involves opening the skin on the arm up to expose the muscle and tendon. There is a total of 1 incision made.

Intervention Type

Procedure

Intervention Name(s)

Debridement and repair

Intervention Description

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 Information:

Title

symptom severity and functional outcome score (Patient Rated Tennis Elbow Evaluation)

Description

The primary outcome measure will be the difference btetwee the pre and post operative assessments of questionnaire and symptom severity.

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tuna Ozyurekoglu, MD

Phone

502-561-4286

tozyurekoglu@kleinertkutz.com

First Name & Middle Initial & Last Name or Official Title & Degree

Millicent L Horn, BS

Phone

502-562-0307

mhorn@cmki.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tuna Ozyurekoglu, MD

Organizational Affiliation

Christine M. Kleinert Institute of Hand and Microsurgery

Official's Role

Principal Investigator

Facility Information:

Facility Name

Christine M. Kleinert Institute of Hand and Microsurgery

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christina L Kaufman, PhD

Phone

502-562-0390

ckaufman@cmki.org

First Name & Middle Initial & Last Name & Degree

Millicent L Horn, BS

Phone

502-562-0307

mhorn@cmki.org

12. IPD Sharing Statement

Learn more about this trial

Comparison of Surgical Interventions for Lateral Epicondylitis: A Prospective Study

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