Efficacy Evaluation of Surgical Treatment Using Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)

Who is this study for? Patients with Tennis Elbow, Lateral Epicondylitis
What treatments are being studied? Lateral Epicondylectomy+Ultrasound Imaging
Status: Recruiting
Location: See location...
Intervention Type: Biological, Radiation, Procedure
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

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

Locations
United States
Michigan
Henry Ford Hospital
RECRUITING
Detroit
Contact Information
Primary
Johnny Kasto, MD
jkasto1@hfhs.org
3132448078
Time Frame
Start Date: 2019-04-17
Estimated Completion Date: 2027-01-17
Participants
Target number of participants: 40
Treatments
Active_comparator: Control
Surgical treatment alone, consisting of tendon debridement and repair. Ultrasounds preoperatively and 6 months postoperatively.
Experimental: Experimental
Identical surgical treatment plus Smith \& Nephew bio-inductive patch implant. Ultrasounds preoperatively and 6 months postoperatively.
Related Therapeutic Areas
Sponsors
Collaborators: Smith & Nephew, Inc.
Leads: Henry Ford Health System

This content was sourced from clinicaltrials.gov