ORTHOVISC Shoulder Osteoarthritis Study

DePuy Synthes

Status and phase: Completed; Phase 3

Conditions: Glenohumeral Osteoarthritis

Treatments: Device: Orthovisc; Drug: Control

Study type: Interventional

Funder types: Industry

Identifiers

NCT00436969

06-OV-01

Details and patient eligibility

About

A comparison of Orthovisc to corticosteroid injections in the shoulder for pain due to osteoarthritis.

Full 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.

Enrollment: 274 patients

Sex: All

Ages: 25 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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274 participants in 2 patient groups

Control

Active Comparator group

Description:

Subjects randomized to the control arm injection of prescribed anesthetic and corticosteroid, shall receive an equivalent volume (8 mL's).

Treatment:

Drug: Control

Investigational

Experimental group

Description:

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.

Treatment:

Device: Orthovisc