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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

Tracking Information
First Submitted Date  ICMJE October 23, 2018
First Posted Date  ICMJE October 24, 2018
Last Update Posted Date April 11, 2019
Estimated Study Start Date  ICMJE April 17, 2019
Estimated Primary Completion Date March 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2018)
  • PROMIS CAT Scores [ Time Frame: Preoperative to 1 year postoperative ]
    A short 5 minute survey asking questions about physical function, pain, and mental health
  • 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
  • Range of Motion [ Time Frame: Preoperative to 1 year ]
    Standard range of motion values collected by the surgeon during preoperative and followup visits
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)
Official Title  ICMJE Efficacy Evaluation of Surgical Treatment Using Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE
  • Tennis Elbow
  • Lateral Epicondylitis
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Active Comparator: Control
    Surgical treatment alone, consisting of tendon debridement and repair. Ultrasounds preoperatively and 6 months postoperatively.
    Interventions:
    • Procedure: Lateral Epicondylectomy
    • Radiation: Ultrasound Imaging
  • Experimental: Experimental
    Identical surgical treatment plus Smith & Nephew bio-inductive patch implant. Ultrasounds preoperatively and 6 months postoperatively.
    Interventions:
    • Biological: Smith & Nephew Bioinductive Implant
    • Procedure: Lateral Epicondylectomy
    • Radiation: Ultrasound Imaging
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 23, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 30, 2020
Estimated Primary Completion Date March 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03718637
Other Study ID Numbers  ICMJE 12495
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No IPD will be shared with other researchers.
Responsible Party Stephanie Muh, MD, Henry Ford Health System
Study Sponsor  ICMJE Henry Ford Health System
Collaborators  ICMJE Smith & Nephew, Inc.
Investigators  ICMJE
Principal Investigator: Stephanie J Muh, MD Henry Ford Health System
PRS Account Henry Ford Health System
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP