Actively Recruiting
Efficacy Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)
Led by Henry Ford Health System · Updated on 2025-03-12
40
Participants Needed
1
Research Sites
404 weeks
Total Duration
On this page
Sponsors
H
Henry Ford Health System
Lead Sponsor
S
Smith & Nephew, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of lateral epicondylitis (tennis elbow) that has failed conservative treatment including physical therapy, activity change, and anti-inflammatory treatment.
You will not qualify if you...
- Previous surgery on the currently-affected elbow.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
Research Team
J
Johnny Kasto, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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