Efficacy Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)

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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

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

Trial contacts and locations

0

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Central trial contact

Johnny Kasto, MD

Data sourced from clinicaltrials.gov

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