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Efficacy Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)

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ClinicalTrials.gov Identifier: NCT03718637
Recruitment Status : Unknown
Verified April 2019 by Stephanie Muh, MD, Henry Ford Health System.
Recruitment status was:  Not yet recruiting
First Posted : October 24, 2018
Last Update Posted : April 11, 2019
Sponsor:
Collaborator:
Smith & Nephew, Inc.
Information provided by (Responsible Party):
Stephanie Muh, MD, Henry Ford Health System

Brief Summary:
The investigators are testing the efficacy of a new, FDA-approved bioinductive patch in lateral epicondylitis (tennis elbow) patients. A bioinductive patch is an implant that may foster tendon regrowth and healing following surgery. Patients will be randomize into one of two groups: control and investigational. Patients in the "control group" will receive the normal surgery for patients who do not respond to physical therapy, lifestyle changes, and anti-inflammatory treatment. Patients in the "experimental group" will receive the same surgical treatment, with the addition of the bioinductive patch. This patch will be implanted during surgery. Then, using a combination of ultrasound studies and other measures, the investigators will assess how well the patch works compared to surgery alone.

Condition or disease Intervention/treatment Phase
Tennis Elbow Lateral Epicondylitis Biological: Smith & Nephew Bioinductive Implant Procedure: Lateral Epicondylectomy Radiation: Ultrasound Imaging Phase 4

Detailed Description:
A bioinductive patch is an implant that may foster tendon regrowth and healing following surgery. Patients will be randomized into one of two groups: control and investigational. All surgical patients will have failed non surgery options for 6 months (physical therapy, lifestyle changes, anti-inflammatories, injections) Patients in the "control group" will receive the standard surgery (open lateral epicondylectomy) . Patients in the "experimental group" will receive the same surgical treatment, with the addition of the bioinductive patch. This patch will be implanted during surgery. Then, using a combination of ultrasound studies and other measures, the investigators will assess how well the patch works compared to surgery alone.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomized into one of two groups. In the "control group," patients will receive the current surgical treatment for lateral epicondylitis: tendon debridement and repair. Patients in the "experimental group" will receive a bio-inductive patch following the same surgical treatment. Both groups of patients will participate in preoperative and postoperative ultrasound imaging studies.
Masking: Single (Participant)
Masking Description: The study participant will not have knowledge of which treatment group he/she is randomized into for the duration of the study. Because the care provider/investigator will be required to implant the bioinductive patch, the physician will know into which treatment group each patient falls.
Primary Purpose: Treatment
Official Title: Efficacy Evaluation of Surgical Treatment Using Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)
Estimated Study Start Date : April 17, 2019
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control
Surgical treatment alone, consisting of tendon debridement and repair. Ultrasounds preoperatively and 6 months postoperatively.
Procedure: Lateral Epicondylectomy
This procedure is the standard of care for lateral epicondylitis patients who fail conservative treatment options.

Radiation: Ultrasound Imaging
An ultrasound will be performed on each patient both preoperatively and at 6 months.

Experimental: Experimental
Identical surgical treatment plus Smith & Nephew bio-inductive patch implant. Ultrasounds preoperatively and 6 months postoperatively.
Biological: Smith & Nephew Bioinductive Implant
A bioinductive implant that is supposed to foster healthy tendon regrowth after surgery.
Other Name: Bioinductive Patch

Procedure: Lateral Epicondylectomy
This procedure is the standard of care for lateral epicondylitis patients who fail conservative treatment options.

Radiation: Ultrasound Imaging
An ultrasound will be performed on each patient both preoperatively and at 6 months.




Primary Outcome Measures :
  1. PROMIS CAT Scores [ Time Frame: Preoperative to 1 year postoperative ]
    A short 5 minute survey asking questions about physical function, pain, and mental health

  2. Visual Analog Scale (VAS) for Pain [ Time Frame: Preoperative to 1 year postoperative ]
    Traditional 1 to 10, subjective rating of pain the patient is experiencing

  3. Range of Motion [ Time Frame: Preoperative to 1 year ]
    Standard range of motion values collected by the surgeon during preoperative and followup visits



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of lateral epicondylitis (tennis elbow) that has failed conservative treatment (Physical therapy, activity change, anti-inflammatory treatment.

Exclusion Criteria:

  • Previous surgery on the currently-affected elbow.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03718637


Contacts
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Contact: Noah A Kuhlmann, MS 616-482-9675 nkuhlma1@hfhs.org

Locations
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United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Henry Ford Health System
Smith & Nephew, Inc.
Investigators
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Principal Investigator: Stephanie J Muh, MD Henry Ford Health System
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Responsible Party: Stephanie Muh, MD, Deputy Service Chief, Principal Investigator, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT03718637    
Other Study ID Numbers: 12495
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD will be shared with other researchers.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Stephanie Muh, MD, Henry Ford Health System:
Tennis Elbow
Tendinopathy
Lateral Epicondylitis
Bioinductive
Additional relevant MeSH terms:
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Tennis Elbow
Elbow Tendinopathy
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries