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

PHASE1/PHASE2UnknownINTERVENTIONAL
Enrollment

78

Participants

Timeline

Start Date

July 26, 2022

Primary Completion Date

December 31, 2023

Study Completion Date

May 31, 2024

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.

Trial Locations (9)

14226

RECRUITING

University of Buffalo Orthopaedic & Sports Medicine, Buffalo

16801

RECRUITING

University Orthopedics Center, State College

19107

RECRUITING

Rothman Orthopaedic Institute, Philadelphia

21045

RECRUITING

Johns Hopkins University, Columbia

23294

RECRUITING

OrthoVirginia, Richmond

33334

RECRUITING

Holy Cross Orthopedic Research Institute, Fort Lauderdale

35205

RECRUITING

American Sports Medicine Institute, Birmingham

46074

RECRUITING

The Orthopaedic Research Foundation, Inc., Indianapolis

85712

RECRUITING

Tucson Orthopedics, Tucson

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

MCRA

INDUSTRY

lead

ChitogenX Inc

INDUSTRY