NCT01618487

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2012

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2012

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

7.3 years

First QC Date

June 11, 2012

Last Update Submit

January 23, 2018

Conditions

Lateral EpicondylitisTennis Elbow

Keywords

tennis elbowlateral epicondylitis

Outcome Measures

Primary Outcomes (1)

  • 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.

    24 months

Study Arms (3)

Arthroscopic tenotomy

ACTIVE COMPARATOR

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

Procedure: Arthroscopic tenotomy

Open tenotomy

ACTIVE COMPARATOR

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

Debridement and repair

ACTIVE COMPARATOR

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

Interventions

Arthroscopic tenotomyPROCEDURE

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

Arthroscopic tenotomy
Open tenotomyPROCEDURE

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

Open tenotomy
Debridement and repairPROCEDURE

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.

Debridement and repair

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christine M. Kleinert Institute of Hand and Microsurgery

Louisville, Kentucky, 40202, United States

RECRUITING

MeSH Terms

Conditions

Tennis Elbow

Interventions

DebridementWound Healing

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

Surgical Procedures, OperativeRegenerationBiological Phenomena

Study Officials

  • Tuna Ozyurekoglu, MD

    Christine M. Kleinert Institute of Hand and Microsurgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tuna Ozyurekoglu, MD

CONTACT

502-561-4286tozyurekoglu@kleinertkutz.com

Millicent L Horn, BS

CONTACT

502-562-0307mhorn@cmki.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2012

First Posted

June 13, 2012

Study Start

February 1, 2012

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

January 25, 2018

Record last verified: 2018-01

Locations

US(1)