Prospective Single Center Open Label Study of Shoulder OA Pain

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

Detailed Description
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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.

Official Title
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A 26 Week Prospective Open Label Clinical Study Evaluating A Single Intra-Articular Injection of Durolane 3ml for Treatment of Osteoarthritis Pain of the Shoulder

Conditions
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Osteoarthritis

Intervention / Treatment
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* Device: Durolane


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Durolane 3ml<br>Single intra-articular injection into shoulder | Device: Durolane<br>* single injection of 3ml<br>* Other names: Hyaluronic Acid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder pain on movement (SPOM) 0-100mm VAS |  | over 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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degenerative arthritis