NCT05333211

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

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: ChitogenX Inc · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Rotator Cuff Tears

Interventions

Type	Name	Description
DRUG	Ortho-R/PRP	Ortho-R® is a freeze-dried drug/biologic combination product containing a chitosan component and trehalose, a disaccharide that acts as a lyoprotectant during the lyophilization process and calcium chloride, which acts as a PRP coagulation agent.

Timeline

• Start date: 2022-07-26
• Primary completion: 2023-12-01
• Completion: 2024-05-01
• First posted: 2022-04-18
• Last updated: 2023-03-21

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study