Actively Recruiting
Efficacy Evaluation of Surgical Treatment Using Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)
Led by Henry Ford Health System · Updated on 2025-03-12
40
Participants Needed
1
Research Sites
35 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
Researchers are evaluating the effectiveness of a new, FDA-approved bioinductive patch for patients with lateral epicondylitis, also known as tennis elbow. This condition affects the tendons around the elbow and can cause pain and limited movement. The study compares the standard surgical treatment to surgery combined with this bioinductive implant to see if the patch helps tendon regrowth and healing after surgery. Participants will be randomly assigned to one of two groups. The control group will receive the standard surgery called lateral epicondylectomy, which removes damaged tendon tissue. The experimental group will undergo the same surgery but with the addition of the bioinductive patch implanted during the procedure. Ultrasound imaging will be used before surgery and six months afterward to monitor tendon healing. Throughout the study, participants will be followed for one year with assessments including PROMIS CAT scores, a pain scale called the Visual Analog Scale (VAS), and range of motion measurements. These will be taken before surgery and at various points up to one year after surgery. The study aims to determine if adding the bioinductive patch improves recovery compared to surgery alone.
CONDITIONS
Brief 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 such as physical therapy, activity change, or anti-inflammatory treatment
- Male gender
- Age 18 years or older
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo surgical treatment for tennis elbow. The experimental group receives the bioinductive implant in addition to standard surgery. Ultrasound imaging is performed preoperatively during this stage.
1 surgical visit (in-person)
Duration - 6 months
Participants are followed for recovery and tendon healing, including ultrasound imaging at 6 months postoperatively to assess treatment effectiveness.
1 follow-up visit at 6 months (in-person)
Trial Site Locations
Total: 1 location
1
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
Research Team
J
Johnny Kasto, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here