Lateral Epicondylitis, Tennis Elbow
Conditions
Keywords
Tennis Elbow, Tendinopathy, Lateral Epicondylitis, Bioinductive
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.
Interventions
BIOLOGICALSmith & Nephew Bioinductive Implant
A bioinductive implant that is supposed to foster healthy tendon regrowth after surgery.
PROCEDURELateral Epicondylectomy
This procedure is the standard of care for lateral epicondylitis patients who fail conservative treatment options.
RADIATIONUltrasound Imaging
An ultrasound will be performed on each patient both preoperatively and at 6 months.
Sponsors
Smith & Nephew, Inc.
Henry Ford Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
The study participant will not have knowledge of which treatment group he/she is randomized into for the duration of the study. Because the care provider/investigator will be required to implant the bioinductive patch, the physician will know into which treatment group each patient falls.
Intervention model description
Patients will be randomized into one of two groups. In the control group, patients will receive the current surgical treatment for lateral epicondylitis: tendon debridement and repair. Patients in the experimental group will receive a bio-inductive patch following the same surgical treatment. Both groups of patients will participate in preoperative and postoperative ultrasound imaging studies.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS CAT Scores | Preoperative to 1 year postoperative | A short 5 minute survey asking questions about physical function, pain, and mental health |
| Visual Analog Scale (VAS) for Pain | Preoperative to 1 year postoperative | Traditional 1 to 10, subjective rating of pain the patient is experiencing |
| Range of Motion | Preoperative to 1 year | Standard range of motion values collected by the surgeon during preoperative and followup visits |
Countries
United States
Contacts
Primary ContactJohnny Kasto, MD
Outcome results
None listed