Clinical trial NCT03718637: Efficacy Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)
Official title: Efficacy Evaluation of Surgical Treatment Using Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Tennis Elbow
Lateral Epicondylitis
Keywords: Tennis Elbow
Tendinopathy
Lateral Epicondylitis
Bioinductive
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: Smith & Nephew, Inc.
First posted: 2018-10-24
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: PROMIS CAT Scores
timeFrame: Preoperative to 1 year postoperative
measure: Visual Analog Scale (VAS) for Pain
timeFrame: Preoperative to 1 year postoperative
measure: Range of Motion
timeFrame: Preoperative to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
Study officials:
affiliation: Henry Ford Health System
name: Stephanie J Muh, MD
role: PRINCIPAL_INVESTIGATOR
References: