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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
A bioinductive implant that is supposed to foster healthy tendon regrowth after surgery.
This procedure is the standard of care for lateral epicondylitis patients who fail conservative treatment options.
An ultrasound will be performed on each patient both preoperatively and at 6 months.
Henry Ford Hospital
Detroit, Michigan, United States
RECRUITINGPROMIS CAT Scores
A short 5 minute survey asking questions about physical function, pain, and mental health
Time frame: Preoperative to 1 year postoperative
Visual Analog Scale (VAS) for Pain
Traditional 1 to 10, subjective rating of pain the patient is experiencing
Time frame: Preoperative to 1 year postoperative
Range of Motion
Standard range of motion values collected by the surgeon during preoperative and followup visits
Time frame: Preoperative to 1 year
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