Testing a new implant for treating tennis elbow
Efficacy Evaluation of Surgical Treatment Using Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)
This study is testing a new patch to see if it can help people with tennis elbow heal better after surgery compared to just having the standard surgery alone.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Henry Ford Health System Academic / other |
| Locations | 1 site (Detroit, Michigan) |
| Trial ID | NCT03718637 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy of a bioinductive patch in patients with lateral epicondylitis, commonly known as tennis elbow. Participants will be randomized into two groups: one receiving standard surgical treatment and the other receiving the same surgery with the addition of the bioinductive patch. The study aims to assess the effectiveness of the patch in promoting tendon healing and regrowth compared to surgery alone, using ultrasound and other evaluation methods. All participants will have previously failed conservative treatment options for their condition.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with lateral epicondylitis who have not responded to conservative treatments for at least six months.
Not a fit: Patients who have previously undergone surgery on the affected elbow will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance recovery and healing for patients suffering from tennis elbow.
How similar studies have performed: While the use of bioinductive implants is a relatively novel approach, similar studies have shown promising results in tendon healing.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Detroit, Michigan
- Henry Ford Hospital — Detroit, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Stephanie J Muh, MD — Henry Ford Health System
- Study coordinator: Johnny Kasto, MD
- Email: jkasto1@hfhs.org
- Phone: 3132448078
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.