Efficacy Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)
- Conditions
- Lateral EpicondylitisTennis Elbow
- Interventions
- Procedure: Lateral EpicondylectomyBiological: Smith & Nephew Bioinductive ImplantRadiation: Ultrasound Imaging
- Registration Number
- NCT03718637
- Lead Sponsor
- Henry Ford Health System
- Brief 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.
- Detailed Description
A bioinductive patch is an implant that may foster tendon regrowth and healing following surgery. Patients will be randomized into one of two groups: control and investigational. All surgical patients will have failed non surgery options for 6 months (physical therapy, lifestyle changes, anti-inflammatories, injections) Patients in the "control group" will receive the standard surgery (open lateral epicondylectomy) . 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 40
- Diagnosis of lateral epicondylitis (tennis elbow) that has failed conservative treatment (Physical therapy, activity change, anti-inflammatory treatment.
- Previous surgery on the currently-affected elbow.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Lateral Epicondylectomy Surgical treatment alone, consisting of tendon debridement and repair. Ultrasounds preoperatively and 6 months postoperatively. Experimental Ultrasound Imaging Identical surgical treatment plus Smith \& Nephew bio-inductive patch implant. Ultrasounds preoperatively and 6 months postoperatively. Experimental Smith & Nephew Bioinductive Implant Identical surgical treatment plus Smith \& Nephew bio-inductive patch implant. Ultrasounds preoperatively and 6 months postoperatively. Experimental Lateral Epicondylectomy Identical surgical treatment plus Smith \& Nephew bio-inductive patch implant. Ultrasounds preoperatively and 6 months postoperatively. Control Ultrasound Imaging Surgical treatment alone, consisting of tendon debridement and repair. Ultrasounds preoperatively and 6 months postoperatively.
- Primary Outcome Measures
Name Time Method Visual Analog Scale (VAS) for Pain Preoperative to 1 year postoperative Traditional 1 to 10, subjective rating of pain the patient is experiencing
PROMIS CAT Scores Preoperative to 1 year postoperative A short 5 minute survey asking questions about physical function, pain, and mental health
Range of Motion Preoperative to 1 year Standard range of motion values collected by the surgeon during preoperative and followup visits
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States