Status:
COMPLETED
ORTHOVISC Shoulder Osteoarthritis Study
Lead Sponsor:
DePuy Mitek
Conditions:
Glenohumeral Osteoarthritis
Eligibility:
All Genders
25-75 years
Phase:
PHASE3
Brief Summary
A comparison of Orthovisc to corticosteroid injections in the shoulder for pain due to osteoarthritis.
Detailed Description
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...
Eligibility Criteria
Inclusion
- A candidate for unilateral treatment of osteoarthritis of the shoulder
- Have failed conservative treatment
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
274 Patients enrolled
Trial Details
Trial ID
NCT00436969
Start Date
December 1 2006
End Date
August 1 2011
Last Update
March 9 2017
Active Locations (13)
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1
CORE Orthopedics
Encinitas, California, United States, 92024
2
Sierra Pacific Orthopaedic Center Medical Group
Fresno, California, United States, 93720
3
UHZ Sports Medicine
Coral Gables, Florida, United States, 33146
4
Andrews Research Institute
Gulf Breeze, Florida, United States, 32561