Efficacy Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)

Henry Ford Health

Status and phase: Enrolling; Phase 4

Conditions: Tennis Elbow; Lateral Epicondylitis

Treatments: Biological: Smith & Nephew Bioinductive Implant; Procedure: Lateral Epicondylectomy; Radiation: Ultrasound Imaging

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03718637

12495

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Control

Active Comparator group

Description:

Surgical treatment alone, consisting of tendon debridement and repair. Ultrasounds preoperatively and 6 months postoperatively.

Treatment:

Radiation: Ultrasound Imaging

Procedure: Lateral Epicondylectomy

Experimental

Experimental group

Description:

Identical surgical treatment plus Smith & Nephew bio-inductive patch implant. Ultrasounds preoperatively and 6 months postoperatively.

Treatment:

Radiation: Ultrasound Imaging

Procedure: Lateral Epicondylectomy

Biological: Smith & Nephew Bioinductive Implant