Efficacy Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age18+
SponsorHenry Ford Health System

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Previous surgery on the currently-affected elbow.

Trial design

Treatments tested in this trial

  • Smith & Nephew Bioinductive Implant
  • Lateral Epicondylectomy
  • Ultrasound Imaging

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Henry Ford Health System

Lead sponsor

Smith & Nephew, Inc.

Collaborator