Three Injections of EUFLEXXA (Sodium Hyaluronate) for Treatment of Chronic Shoulder Pain Associated With Osteoarthritis (OA)

Study Overview
=================
Brief Summary
-----------------
The hypothesis of this study is that by using 3 injections of EUFLEXXA, there will be an improvement in pain levels and range of motion.

Detailed Description
-----------------
To demonstrate that EUFLEXXA is safe for the treatment of chronic shoulder pain associated with osteoarthritis.

Official Title
-----------------
Investigator Initiated, Exploratory Case Study Three Injections of EUFLEXXA (Sodium Hyaluronate)Treatment of Chronic Shoulder Pain Associated With Osteoarthritis

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Drug: EUFLEXXA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be age 30 to 79 Give written informed consent for trial participation Must have shoulder pain for a minimum of 6 months but less than 5 years Must have a Pain Intensity Score of > 5 Must be willing to discontinue all pain medications 24 hours prior to each clinic visit Must have a stable pain medication regime 1 month prior to treatment Agrees to maintain pain medication doses within 30% (increase or decrease) of the Baseline dose Exclusion Criteria: Any history of full thickness rotator cuff tear or joint effusion A diagnosis of chronic acromioclavical disease, active epicondylitis, or active Carpal Tunnel Disease Has had more than 2 corticosteroid injections in the previous 3 months Has an infection or an inflammatory condition of the trial shoulder Has acute or inflammatory arthropathy in the trial shoulder, e.g. gouty arthritis, psoriatic arthritis or rheumatoid arthritis. Has a history of systemic inflammatory arthropathies, e.g. polyarthritis, rheumatoid arthritis, psoriatic arthritis or gout Has severe joint effusion of the trial shoulder Has a diagnosis of cancer within the past 5 years (basal cell carcinoma is not excluded) Has had any hyaluronate agent or other chondroprotective agents in the trial shoulder Has a hypersensitivity to HA products, eggs, birds or feathers Has a history of substance abuse, alcohol abuse or psychiatric condition, that in the opinion of the Investigator, will potentially interfere with participation Has any medical condition that may increase the risk associated with intra-articular injections, to include (but are not limited to): thrombocytopenia, blood disorders treated with warfarin or anticoagulants, anemia or other concomitant diseases that, in the opinion of the Investigator, will interfere with the evaluation of the trial treatment, e.g., renal or liver disease, uncontrolled diabetes, significant cardiovascular, immune deficiency, or infectious disease Is actively involved in a litigation involving Workers' Compensation Is a female that is pregnant, planning to become pregnant or is lactating Has participated in a clinical trial within the past four weeks

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 79 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EUFLEXXA<br>ACTIVE CONTROL | Drug: EUFLEXXA<br>* 2.5 mL of EUFLEXXA (per injection) x 3 injections<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With a Reduction in Pain by the Scores. | Greater than 50 percent reduction in pain scores from baseline. | 6 months |