Bioinductive Patch for Full-Thickness Rotator Cuff Tears

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

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-16

Study Completion Date

2027-12-01

Brief Summary

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The purpose of this randomized-controlled study is to compare outcomes of arthroscopic rotator cuff repair augmented with a Bioinductive Implant (study group) to standard arthroscopic rotator cuff repair (control group). The primary outcome of this study is rotator cuff repair integrity (absence of full- or partial-thickness defect) demonstrated on ultrasound at 1-year postoperatively. The investigators hypothesize that the study group will have higher rates of repair integrity demonstrated on ultrasound at 1-year postoperatively.

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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-surgical/conservative options for 6 weeks. Patients in the "control group" will receive the standard surgery (arthroscopic rotator cuff repair) . 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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Rotator Cuff Tears Rotator Cuff Tear Arthropathy

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 rotator cuff tears: 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 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 Group

Surgical treatment alone, consisting of arthroscopic rotator cuff repair. Ultrasound postoperatively at 1 year.

Group Type ACTIVE_COMPARATOR

arthroscopic rotator cuff repair

Intervention Type PROCEDURE

This procedure is the standard of care for rotator cuff tears who fail conservative treatment options.

Ultrasound Imaging

Intervention Type DIAGNOSTIC_TEST

An ultrasound will be performed on each patient one year postoperatively.

Study Group

Identical surgical treatment as control group plus bio-inductive patch implant. Ultrasound postoperatively at 1 year.

Group Type EXPERIMENTAL

arthroscopic rotator cuff repair

Intervention Type PROCEDURE

This procedure is the standard of care for rotator cuff tears who fail conservative treatment options.

Bioinductive implant

Intervention Type BIOLOGICAL

A bioinductive implant that is designed to promote healing of the torn rotator cuff tendon after surgery.

Ultrasound Imaging

Intervention Type DIAGNOSTIC_TEST

An ultrasound will be performed on each patient one year postoperatively.

Interventions

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arthroscopic rotator cuff repair

This procedure is the standard of care for rotator cuff tears who fail conservative treatment options.

Intervention Type PROCEDURE

Bioinductive implant

A bioinductive implant that is designed to promote healing of the torn rotator cuff tendon after surgery.

Intervention Type BIOLOGICAL

Ultrasound Imaging

An ultrasound will be performed on each patient one year postoperatively.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Bioinductive patch

Eligibility Criteria

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Inclusion Criteria

* Indicated and scheduled for arthroscopic rotator cuff repair.
* Full-thickness medium (1-3 cm), large (3-5 cm), and massive (\>5 cm) rotator cuff tears involving the supraspinatus and/or infraspinatus tendons demonstrated on magnetic resonance or ultrasound imaging.
* Chronic, degenerative rotator cuff tears.
* Ability to read and understand English.
* Age ≥18 years
* Patient failed ≥6 weeks of conservative treatment, which included structured, in-person physical therapy or documented home therapy

Exclusion Criteria

* Patient scheduled for open or mini-open rotator cuff repair
* Prior surgery of affected shoulder (except diagnostic arthroscopy)
* Partial-thickness rotator cuff tears
* Small (\<1 cm) rotator cuff tears
* Rotator cuff tears involving the subscapularis tendon
* Acute and traumatic rotator cuff tears
* Active infection
* Cancer
* Autoimmune and rheumatologic disorders, including rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No