Osteoarthritis of the Shoulder
Conditions
Keywords
Osteoarthritis, Shoulder, Hyaluronic Acid (HA)
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
Interventions
DEVICESUPARTZ®
Three Supartz injections over 2 weeks into the glenohumeral joint space.
Three phosphate buffered saline injections over 2 weeks into the glenohumeral joint space.
Sponsors
Bioventus LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ph1: Supartz (Double Blind) SUPARTZ® 3 injections over 2 weeks
SUPARTZ®: Three Supartz injections over 2 weeks into the glenohumeral joint space. | 150 |
| Ph1: Phosphate Buffered Saline (Double Blind) Phosphate Buffered Saline 3 injections over 2 weeks
Phosphate Buffered Saline: Three phosphate buffered saline injections over 2 weeks into the glenohumeral joint space. | 150 |
| Total | 300 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Ph 1: Blinded, Randomized, Controlled | Adverse Event | 0 | 2 | 0 |
| Ph 1: Blinded, Randomized, Controlled | Death | 0 | 1 | 0 |
| Ph 1: Blinded, Randomized, Controlled | Lost to Follow-up | 4 | 5 | 0 |
| Ph 1: Blinded, Randomized, Controlled | Physician Decision | 2 | 0 | 0 |
| Ph 1: Blinded, Randomized, Controlled | Withdrawal by Subject | 19 | 11 | 0 |
| Ph 2: Open Label, Single (Supartz) Arm | Adverse Event | 0 | 0 | 4 |
| Ph 2: Open Label, Single (Supartz) Arm | Death | 0 | 0 | 1 |
| Ph 2: Open Label, Single (Supartz) Arm | Lost to Follow-up | 0 | 0 | 1 |
| Ph 2: Open Label, Single (Supartz) Arm | Withdrawal by Subject | 0 | 0 | 3 |
Baseline characteristics
| Characteristic | Ph1: Supartz (Double Blind) | Ph1: Phosphate Buffered Saline (Double Blind) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 82 Participants | 85 Participants | 167 Participants |
| Age, Categorical Between 18 and 65 years | 68 Participants | 65 Participants | 133 Participants |
| Age, Continuous | 65.9 years STANDARD_DEVIATION 10.7 | 65.7 years STANDARD_DEVIATION 11.8 | 65.8 years STANDARD_DEVIATION 11.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 6 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 146 Participants | 144 Participants | 290 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 8 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 143 Participants | 140 Participants | 283 Participants |
| Sex: Female, Male Female | 61 Participants | 75 Participants | 136 Participants |
| Sex: Female, Male Male | 89 Participants | 75 Participants | 164 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 54 / 150 | 56 / 150 | 21 / 224 |
| serious Total, serious adverse events | 11 / 150 | 5 / 150 | 5 / 224 |
Outcome results
Primary
Visual Analogue Scale (VAS: 0-100) for Pain on Movement
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
Time frame: Ph1: weeks 7 - 26
Population: Glenohumeral Osteoarthritis (GH-OA) Intention-to-Treat (ITT) population includes all randomized subjects who had no clinical diagnosis of concomitant pathologies in the trial shoulder
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Ph1: Supartz (Double Blind) | Visual Analogue Scale (VAS: 0-100) for Pain on Movement | 53.7665 units on a scale | Standard Error 1.7513 |
| Ph1: Phosphate Buffered Saline (Double Blind) | Visual Analogue Scale (VAS: 0-100) for Pain on Movement | 57.7659 units on a scale | Standard Error 1.7569 |
p-value: 0.038Mixed Models Analysis