SUPARTZ Versus Placebo in Osteoarthritis of the Shoulder

Bioventus

Status: Completed

Conditions: Osteoarthritis of the Shoulder

Treatments: Device: SUPARTZ®; Device: Phosphate Buffered Saline

Study type: Interventional

Funder types: Industry

Identifiers

NCT00479687

SHO-0106

Details and patient eligibility

About

This clinical trial is to determine the safety and effectiveness of three injections of SUPARTZ (sodium hyaluronate) compared with phosphate buffered saline (PBS) for the treatment of glenohumeral osteoarthritis of the shoulder. The trial contains two phases. Phase I is 26 weeks, double blinded, and subjects are randomized to either SUPARTZ or PBS treatment. Phase II is 26 weeks (total 52 weeks) and open-label so all subjects will receive SUPARTZ injections only.

Full description

Phase 3 Study: Multi-center, randomized, double blinded, two phase study to determine the safety and efficacy of 3 injections of SUPARTZ for Osteoarthritis of the Shoulder

Enrollment: 300 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Glenohumeral Osteoarthritis (OA) confirmed by radiograph
• Limitation of shoulder motion in at least one direction
• Retained active range of motion of at least 30% in all directions

Exclusion criteria

• Full thickness rotator cuff tear or rotator cuff tendinopathy
• Frozen shoulder
• Female who is pregnant or lactating

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 2 patient groups, including a placebo group

Supartz

Active Comparator group

Description:

SUPARTZ® 3 injections over 2 weeks

Treatment:

Device: SUPARTZ®

Phosphate Buffered Saline

Placebo Comparator group

Description:

Phosphate Buffered Saline 3 injections over 2 weeks

Treatment:

Device: Phosphate Buffered Saline