ORTHOVISC Shoulder Osteoarthritis Study
Launched by DEPUY MITEK · Feb 16, 2007
Trial Information
Current as of May 29, 2025
Completed
Keywords
ClinConnect Summary
This multicenter, prospective double-blinded, randomized trial will study two treatment groups. Subjects will be randomized to receive either Orthovisc or corticosteroids/anesthetic injection into the shoulder in a 2:1 schema. The trial will assess safety and efficacy of pain relief in the osteoarthritic shoulder.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • A candidate for unilateral treatment of osteoarthritis of the shoulder
- • Have failed conservative treatment
- Exclusion Criteria:
- • Presence of full thickness Rotator Cuff tear and/or significantly compromised rotator cuff function
- • No active instability or acute dislocation episodes within the previous 12 months
- • Known allergy to hyaluronate preparations
- • Pregnant or breast feeding
- • Is receiving prescription pain medication for conditions unrelated to the index shoulder condition
About Depuy Mitek
DePuy Mitek, a subsidiary of Johnson & Johnson, is a leading global provider of orthopedic and surgical solutions, specializing in innovative products for the repair and reconstruction of soft tissues and joints. With a commitment to advancing patient care through cutting-edge technology and research, DePuy Mitek focuses on developing minimally invasive techniques and comprehensive surgical solutions that enhance surgical outcomes and improve the quality of life for patients. The company is dedicated to conducting clinical trials that rigorously evaluate the safety and efficacy of its products, ensuring that healthcare professionals have access to the most effective tools for their surgical interventions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Charlottesville, Virginia, United States
New Orleans, Louisiana, United States
Tacoma, Washington, United States
State College, Pennsylvania, United States
New Orleans, Louisiana, United States
Encinitas, California, United States
Fresno, California, United States
Coral Gables, Florida, United States
Gulf Breeze, Florida, United States
Worcester, Massachusetts, United States
St Clair Shores, Michigan, United States
New York, New York, United States
Tulsa, Oklahoma, United States
Houston, Texas, United States
Patients applied
Trial Officials
Jonathan B. McGlohorn
Study Director
DePuy Synthes Mitek and Biomaterials
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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