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Bioinductive Patch for Full-Thickness Rotator Cuff Tears

RecruitingPhase 4Ages 18 Years - anyAllHenry Ford Health System
NCT05439850 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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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📋 Eligibility rules (as published)
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
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What it tests

  • arthroscopic rotator cuff repair
  • Bioinductive implant
  • Ultrasound Imaging
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Where

1 site
Henry Ford Health
Detroit, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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