Efficacy Bioinductive Implant for Tennis Elbow (Lateral Epicondylitis)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-17

Study Completion Date

2027-01-17

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.

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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.

Conditions

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Tennis Elbow Lateral Epicondylitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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.

Study Groups

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Control

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

Group Type ACTIVE_COMPARATOR

Lateral Epicondylectomy

Intervention Type PROCEDURE

This procedure is the standard of care for lateral epicondylitis patients who fail conservative treatment options.

Ultrasound Imaging

Intervention Type RADIATION

An ultrasound will be performed on each patient both preoperatively and at 6 months.

Experimental

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

Group Type EXPERIMENTAL

Smith & Nephew Bioinductive Implant

Intervention Type BIOLOGICAL

A bioinductive implant that is supposed to foster healthy tendon regrowth after surgery.

Lateral Epicondylectomy

Intervention Type PROCEDURE

This procedure is the standard of care for lateral epicondylitis patients who fail conservative treatment options.

Ultrasound Imaging

Intervention Type RADIATION

An ultrasound will be performed on each patient both preoperatively and at 6 months.

Interventions

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Smith & Nephew Bioinductive Implant

A bioinductive implant that is supposed to foster healthy tendon regrowth after surgery.

Intervention Type BIOLOGICAL

Lateral Epicondylectomy

This procedure is the standard of care for lateral epicondylitis patients who fail conservative treatment options.

Intervention Type PROCEDURE

Ultrasound Imaging

An ultrasound will be performed on each patient both preoperatively and at 6 months.

Intervention Type RADIATION

Other Intervention Names

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Bioinductive Patch

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.