SUPARTZ Versus Placebo in Osteoarthritis of the Shoulder
- Conditions
- Osteoarthritis of the Shoulder
- Interventions
- Device: SUPARTZ®Device: Phosphate Buffered Saline
- Registration Number
- NCT00479687
- Lead Sponsor
- Bioventus LLC
- Brief Summary
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.
- Detailed 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- 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
- Full thickness rotator cuff tear or rotator cuff tendinopathy
- Frozen shoulder
- Female who is pregnant or lactating
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Supartz SUPARTZ® SUPARTZ® 3 injections over 2 weeks Phosphate Buffered Saline Phosphate Buffered Saline Phosphate Buffered Saline 3 injections over 2 weeks
- Primary Outcome Measures
Name Time Method Visual Analogue Scale (VAS: 0-100) for Pain on Movement Ph1: weeks 7 - 26 Visual Analogue Scale (VAS) for pain on (shoulder) movement with a range of 0 to100; where 0=No pain at all and 100=Pain as bad as it can be.
Q: How bad is the pain in your study shoulder with activity or movement? (For example, when putting on a coat, sleeping on your study shoulder side, combing your hair, reaching a high shelf, etc.)
Reported is a single Least square mean point estimate over the 7-26 week time interval using the assessments collected at weeks 7, 13, 20, and 26
- Secondary Outcome Measures
Name Time Method