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

NCT05333211 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2023-03-21

No results posted yet for this study

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.

Conditions

  • Rotator Cuff Tears

Interventions

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.

Sponsors & Collaborators

  • MCRA

    collaborator INDUSTRY

  • ChitogenX Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-26
Primary Completion
2023-12-31
Completion
2024-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05333211 on ClinicalTrials.gov