Efficacy Evaluation of Surgical Treatment Using Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)
Overview
- Phase
- Phase 4
- Intervention
- Lateral Epicondylectomy
- Conditions
- Tennis Elbow
- Sponsor
- Henry Ford Health System
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Visual Analog Scale (VAS) for Pain
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Stephanie Muh, MD
Deputy Service Chief, Principal Investigator
Henry Ford Health System
Eligibility 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.
Arms & Interventions
Control
Surgical treatment alone, consisting of tendon debridement and repair. Ultrasounds preoperatively and 6 months postoperatively.
Intervention: Lateral Epicondylectomy
Control
Surgical treatment alone, consisting of tendon debridement and repair. Ultrasounds preoperatively and 6 months postoperatively.
Intervention: Ultrasound Imaging
Experimental
Identical surgical treatment plus Smith \& Nephew bio-inductive patch implant. Ultrasounds preoperatively and 6 months postoperatively.
Intervention: Smith & Nephew Bioinductive Implant
Experimental
Identical surgical treatment plus Smith \& Nephew bio-inductive patch implant. Ultrasounds preoperatively and 6 months postoperatively.
Intervention: Lateral Epicondylectomy
Experimental
Identical surgical treatment plus Smith \& Nephew bio-inductive patch implant. Ultrasounds preoperatively and 6 months postoperatively.
Intervention: Ultrasound Imaging
Outcomes
Primary Outcomes
Visual Analog Scale (VAS) for Pain
Time Frame: Preoperative to 1 year postoperative
Traditional 1 to 10, subjective rating of pain the patient is experiencing
PROMIS CAT Scores
Time Frame: Preoperative to 1 year postoperative
A short 5 minute survey asking questions about physical function, pain, and mental health
Range of Motion
Time Frame: Preoperative to 1 year
Standard range of motion values collected by the surgeon during preoperative and followup visits