Conditions: Glenohumeral Osteoarthritis
Keywords: Orthovisc Osteoarthritis Shoulder Randomized
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 274
Healthy volunteers: no

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 shoulder in a 2:1 schema. The trial will assess safety and efficacy of pain relief in the osteoarthritic shoulder.

Arms:
arm 1: Subjects randomized to the control arm injection of prescribed anesthetic and corticosteroid, shall receive an equivalent volume (8 mL's). arm 2: Subjects randomized to the active treatment in this study will receive a one-time dose of 8 mL's of Orthovisc derived from non-animal source bacterial fermentation, S. Equi.

Interventions: intervention 1: Orthovisc intervention 2: Control
Intervention descriptions: intervention 1: Orthovisc injection intervention 2: Celestone (betamethasone sodium phosphate and acetate) - 2 mL

Protocol document: