Prospective Single Center Open Label Study of Shoulder OA Pain

Bioventus

Status: Completed

Conditions: Osteoarthritis

Treatments: Device: Durolane

Study type: Interventional

Funder types: Industry

Identifiers

NCT02610504

13DUR503

Details and patient eligibility

About

Open label, prospective, single cohort study of Durolane 3ml intra-articular injection into the shoulder for pain in mild to moderate patients

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 19 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

Durolane 3ml

Experimental group

Description:

Single intra-articular injection into shoulder

Treatment:

Device: Durolane