Non-Inferiority Study Comparing 3 Weekly Injections of SUPARTZ® vs 3 Weekly Injections of Euflexxa® for Knee OA

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate non-inferiority of three weekly intra-articular injections of SUPARTZ to three weekly intra-articular injections of Euflexxa for the relief of knee OA.

Detailed Description
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The purpose of this study is to demonstrate non-inferiority of three weekly intra-articular injections of SUPARTZ to three weekly intra-articular injections of Euflexxa for the relief of knee joint pain in subjects with osteoarthritis (OA) of the knee as measured by the VAS (0-100 mm) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale score Change from Baseline (CFB) over Weeks 3, 6, 12. Safety will be accessed by recording adverse events, concomitant medications, physical examinations, and vital signs.

Official Title
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Multicenter, Randomized, Double-Blind, Parallel Controlled Non-Inferiority Clinical Trial Comparing 3 Weekly Intra-articular Injections of SUPARTZ® vs 3 Weekly Intra-articular Injections of Euflexxa® for Treatment of Knee OA

Conditions
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Osteoarthritis

Intervention / Treatment
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* Device: Supartz
* Device: Euflexxa


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical evidence of symptomatic osteoarthritis of the study knee as classified according to Altman criteria. Symptoms in study knee for at least one year prior to the screening visit Verified OA of the study knee of Grade 2 or 3 according to a modification of the grading system of Kellgren-Lawrence (K-L) radiographic severity. Willingness to discontinue NSAIDs (systemic and topical) and non-acetaminophen analgesic use seven days or five half-lives prior to the first injection and throughout the study. Exclusion Criteria: Inability to perform a 50 foot walk test. Subjects with rheumatoid arthritis, joint infection, other inflammatory and metabolic arthritis, Lupus or dermatologic disorder or skin conditions in close proximity to study knee that would preclude safe intra-articular injections. Prior hyaluronic acid injections into the study knee within six months of the screening visit. Intra-articular or intra-muscular steroid injections within three months of the screening visit or during study participation. Oral corticosteroids within four weeks of the screening visit or during study participation. History of surgical treatment to the study knee or arthroscopic intervention within three months prior to the screening visit. Clinically apparent tense effusion of the study knee on examination determined by either a positive bulge sign or positive ballottement of the patella (patellar tap). Subjects with clinically diagnosed symptomatic OA of the hip.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Euflexxa<br>Euflexxa® (hyaluronic acid of bacterial origin) | Device: Euflexxa<br>* Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.<br>|
| Experimental: Supartz<br>SUPARTZ® (hyaluronic acid of avian origin) | Device: Supartz<br>* Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC VAS (0:None -100:Extreme) Pain Subscale Score Change From Baseline | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) 0-100mm Pain subscale score Change from Baseline (CFB). Over weeks 3, 6, and 12 least square mean difference in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Visual Analog Scale (VAS) (0mm:None - 100mm:Extreme) pain subscale score Change from Baseline (CFB). A single estimate of least squares mean was calculated using data from baseline, weeks 3, 6, and 12. | Change from Baseline (CFB) over Weeks 3, 6, and 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HA, osteoarthritis, knee pain, Supartz, Euflexxa, hyaluronic acid