Comparison of Surgical Interventions for Lateral Epicondylitis: A Prospective Study

NCT ID: NCT01618487

Last Updated: 2018-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2019-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Lateral Epicondylitis Tennis Elbow

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arthroscopic tenotomy

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

Group Type ACTIVE_COMPARATOR

Arthroscopic tenotomy

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

Open tenotomy

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

Debridement and repair

Intervention Type PROCEDURE

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.

Interventions

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Arthroscopic tenotomy

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

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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Christine M. Kleinert Institute for Hand and Microsurgery

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tuna Ozyurekoglu, MD

Role: PRINCIPAL_INVESTIGATOR

Christine M. Kleinert Institute of Hand and Microsurgery

Locations

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Christine M. Kleinert Institute of Hand and Microsurgery

Louisville, Kentucky, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Tuna Ozyurekoglu, MD

Role: CONTACT

502-561-4286

Millicent L Horn, BS

Role: CONTACT

502-562-0307

Facility Contacts

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Christina L Kaufman, PhD

Role: primary

502-562-0390

Millicent L Horn, BS

Role: backup

502-562-0307

Other Identifiers

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11.0565

Identifier Type: -

Identifier Source: org_study_id

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