Osteoarthritis
Conditions
Keywords
degenerative arthritis
Brief summary
Open label, prospective, single cohort study of Durolane 3ml intra-articular injection into the shoulder for pain in mild to moderate patients
Detailed description
Subjects 19-85 years old will receive a single intra-articular (IA) injection of DUROLANE® 3mL given for the relief of pain in the treatment of symptomatic osteoarthritis (OA) of the shoulder followed over a 26-week time period.
Interventions
DEVICEDurolane
single injection of 3ml
Sponsors
Bioventus LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of glenohumeral osteoarthritis * SPOM score greater than or equal to 50 in study shoulder * Willing to discontinue oral and topical analgesia other than rescue acetaminophen * abstinence from any other IA or per-articular injections for the shoulder during the course of the trial * patients with chronic shoulder pain lasting more than 6 months without clinically significant improvement in pain over the past one month * pain at least 50% of the days during previous month * patients who have failed conventional therapy of NSAIDs or steroid injections * patients with a retained active range of motion of at least 30% in all directions to rule out frozen shoulder * cooperative and able to communicate effectively * agree not to participate in any other studies during trial
Exclusion criteria
* significant pain from other joints requiring chronic analgesic therapy * presence of one or more conditions besides OA that could confound pain and functional assessments * clinically apparent tense effusion, malalignment or instability in study shoulder * shoulder x-rays of acute fractures, sever loss of bone density, avascular necrosis or severe deformity * inability to abstain from analgesic use other than rescue acetaminophen * IA injections of steroids to the study shoulder within 3 months or any other joint within the prior month * IA injection of hyaluronic acid in the study shoulder within 9 months of baseline * allergic reaction to HA * any medical condition which in the opinion of the investigator makes the patient unsuitable for inclusion or may compromise pain assessments of shoulder * uncontrolled hypothyroidism * pregnant or breastfeeding women * planned surgical procedure * history or presence of septic arthritis of study joint or active skin disease or infection in the area of the injection site * treatment with glucosamine/chondroitin initiated or unstable within 3 months of baseline or change in physical therapy for the study shoulder within 1 month of baseline
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Shoulder pain on movement (SPOM) 0-100mm VAS | over 26 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Shoulder pain at night (SPAN) 0-100mm VAS | over 26 weeks |
| American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment form | over 26 weeks |
| Patient Global Assessment (PGA) | over 26 weeks |
| Shoulder pain rescue medication diary | over 26 weeks |
| Adverse events, concomitant medications, physical exam | over 26 weeks |
Countries
Canada
Outcome results
None listed