Efficacy Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy Evaluation of Surgical Treatment Using Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)

Conditions
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Tennis Elbow, Lateral Epicondylitis

Intervention / Treatment
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* Biological: Smith & Nephew Bioinductive Implant
* Procedure: Lateral Epicondylectomy
* Radiation: Ultrasound Imaging


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Surgical treatment alone, consisting of tendon debridement and repair. Ultrasounds preoperatively and 6 months postoperatively. | Procedure: Lateral Epicondylectomy<br>* This procedure is the standard of care for lateral epicondylitis patients who fail conservative treatment options.<br>Radiation: Ultrasound Imaging<br>* An ultrasound will be performed on each patient both preoperatively and at 6 months.<br>|
| Experimental: Experimental<br>Identical surgical treatment plus Smith & Nephew bio-inductive patch implant. Ultrasounds preoperatively and 6 months postoperatively. | Biological: Smith & Nephew Bioinductive Implant<br>* A bioinductive implant that is supposed to foster healthy tendon regrowth after surgery.<br>* Other names: Bioinductive Patch;Procedure: Lateral Epicondylectomy<br>* This procedure is the standard of care for lateral epicondylitis patients who fail conservative treatment options.<br>Radiation: Ultrasound Imaging<br>* An ultrasound will be performed on each patient both preoperatively and at 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS CAT Scores | A short 5 minute survey asking questions about physical function, pain, and mental health | Preoperative to 1 year postoperative | 
| Visual Analog Scale (VAS) for Pain | Traditional 1 to 10, subjective rating of pain the patient is experiencing | Preoperative to 1 year postoperative | 
| Range of Motion | Standard range of motion values collected by the surgeon during preoperative and followup visits | Preoperative to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tennis Elbow, Tendinopathy, Lateral Epicondylitis, Bioinductive