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Bioinductive Patch for Rotator Cuff Tears

This study is looking at a new way to help heal full-thickness rotator cuff tears (a tear in the shoulder's rotator cuff tendons). It compares standard arthroscopic rotator cuff repair (a common surgery for shoulder tears) with the same surgery plus a Bioinductive implant. This implant is designed to encourage the torn tendon to heal better after surgery. You might be able to join if you are scheduled for arthroscopic rotator cuff repair for a medium, large, or massive rotator cuff tear that has not improved with other treatments. The main goal is to see if the Bioinductive implant leads to better healing of the rotator cuff one year after surgery. The study's current status is unclear.

Study design
This is a randomized-controlled study, meaning participants will be randomly assigned to one of two groups. It plans to enroll 78 participants.
What's involved
If you participate, you will have surgery and an ultrasound one year after your operation. You must have failed non-surgical treatments for at least 6 weeks before joining.
Compensation
Not stated in the trial record.
Follow-up
You will have an ultrasound one year after your surgery to check the repair.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05439850

Bioinductive Patch for Full-Thickness Rotator Cuff Tears

Recruiting
PHASE4Ages 18+InterventionalTreatment
Henry Ford Health System
~78 participants
Updated 2026-02-27 on ClinicalTrials.gov
What's tested:arthroscopic rotator cuff repairBioinductive implantUltrasound Imaging

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rotator cuff repair integrity
Measured over Preoperative to 1 year postoperative

Conditions

Rotator Cuff Tears
Rotator Cuff Tear Arthropathy

Explore related trials

Rupture of rotator cuff of shoulder

NCT05439850

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Henry Ford Health

    Detroit, Michiganstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Stephanie J Muh, MC · PRINCIPAL_INVESTIGATOR · Henry Ford Health

Who to contact

Johnny Kasto, MD
[email protected]
313-244-8078
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Rotator cuff repair integrityPreoperative to 1 year postoperative

    absence of full- or partial-thickness defect as demonstrated on ultrasound at 1-year postoperatively.