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Orthovisc vs Corticosteroid in Shoulder Osteoarthritis
NCT00436969Phase 3
Key facts
- Status
- Completed
- Start
- Dec 2006
- Primary completion
- Feb 2010
- Countries
- 1
- Sponsor
- DePuy Synthes
- Modality
- Recombinant Proteins and Enzymes
- Conditions
- glenohumeral osteoarthritis
01
Overview
Phase 3, randomised, double-blind trial of high molecular weight hyaluronic acid in glenohumeral osteoarthritis (2 arms), sponsored by DePuy Synthes. Primary endpoint: Visual Analog Scale Pain Score at 6 months. Started Dec 2006; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Orthovisc
Single injection of 8 mL Orthovisc
Control
Single injection of Corticosteroid (Celestone) + Anesthetic
03
Who it enrols
Patients with unilateral glenohumeral osteoarthritis who have failed conservative treatment. Excludes patients with full thickness rotator cuff tears, instability, or allergy to hyaluronate.
04
Endpoints
Primary
Visual Analog Scale Pain Score
Secondary
Percentage of Responders Using the Visual Analog Scale Pain Score
Visual Analog Scale Pain Score Change From Baseline
American Shoulder and Elbow Surgeons Evaluation Form Patient Score Change From Baseline
Shoulder Pain and Disability Index Total Disability Score Change From Baseline
12-Item Short Form Survey Physical Score Change From Baseline
12-Item Short Form Survey Mental Score Change From Baseline
05
Results
Not all primary endpoints met
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