N/A
N=300
SUPARTZ Versus Placebo in Osteoarthritis of the Shoulder
Osteoarthritis of the Shoulder
Bottom Line
View on ClinicalTrials.gov: NCT00479687 ↗Enrolled (actual)
300
Serious AEs
4.0%
Results posted
Apr 2021
Primary outcome: Primary: Visual Analogue Scale (VAS: 0-100) for Pain on Movement — 53.7665; 57.7659 units on a scale — p=0.0380
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SUPARTZ® (Device); Phosphate Buffered Saline (Device)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- Bioventus LLC
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analogue Scale (VAS: 0-100) for Pain on Movement |
53.7665; 57.7659 | 0.0380 sig |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00479687). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.