Bioinductive Patch for Full-Thickness Rotator Cuff Tears

Henry Ford Health

Status and phase: Enrolling; Phase 4

Conditions: Rotator Cuff Tear Arthropathy; Rotator Cuff Tears

Treatments: Procedure: arthroscopic rotator cuff repair; Diagnostic Test: Ultrasound Imaging; Biological: Bioinductive implant

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05439850

15702

Details and patient eligibility

About

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.

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-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.

Enrollment: 78 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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78 participants in 2 patient groups

Control Group

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: Ultrasound Imaging

Procedure: arthroscopic rotator cuff repair

Study Group

Experimental group

Description:

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

Treatment:

Biological: Bioinductive implant

Diagnostic Test: Ultrasound Imaging

Procedure: arthroscopic rotator cuff repair