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Ortho-R® for Rotator Cuff Repair Compared With Standard of Care Rotator Cuff Repair Without Ortho-R®

Rotator Cuff Tears Clinical Trial

Official title:
A Blinded, Randomized Controlled Study Investigating the Safety of Ortho-R® for Rotator Cuff Repair Compared With Standard of Care

Clinical Trial Summary

Phase I/II, multi-center, prospective, blinded 2arm, parallel design and randomized controlled study. Assessing the Ortho-R/PRP combination and standard of care for rotator cuff repair, will be compared though 12 months.

Clinical Trial Description

Phase I/II, multi-center, prospective, blinded 2arm, parallel design and randomized controlled study. Three subjects will be treated with the investigational arm and will service as training cases. The next 2 randomized intervention cases will be staggered by 48-96 hours and observed for adverse events. Randomized enrollment will then be initiated for all participating sites. Assessment of subjects with Ortho-R/PRP combination with be compared to subjects not randomized to Ortho-R/PRP group receiving standard of care who undergo rotator cuff repair surgery. Patients will be assessed by collecting patient-reported outcomes, MRI, incidence of rotator cuff re-tears, hematology and all adverse events. Data from pre-operative evaluation, day of surgery, and post-operative at 10 days, and 1,3, 6 and 12 months will be collected. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05333211
Study type Interventional
Source ChitogenX Inc
Contact Ana P Villagomez
Phone 5713445114
Email avillagomez@mcra.com
Status Recruiting
Phase Phase 1/Phase 2
Start date July 26, 2022
Completion date May 2024
View Details
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