ActaVisc and ActaVisc Mx Intra-articular Injection for Pain Associated With Osteoarthritis in the Knee

Study Overview
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Brief Summary
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To evaluate the safety and performance of ActaVisc™ intra-articular injection (ActaVisc) and ActaVisc Mx, for management of pain associated with osteoarthritis in the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics

Official Title
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A Prospective, Multi-center, Randomized, Double-blind Feasibility Study to Evaluate the Safety and Performance of ActaVisc and ActaVisc Mx Intra-articular Injection for Management of Pain Associated With Osteoarthritis in the Knee.

Conditions
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Osteoarthritis

Intervention / Treatment
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* Other: ActaVisc and ActaVisc Mx Intra-articular Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Osteoarthritis (OA) grade 2 or 3. Symptoms in the treatment knee for at least 12 months. Fully ambulatory patient. Exclusion Criteria: Secondary OA resulting from rheumatoid arthritis, chondrocalcinosis, osteonecrosis, chronic fibromyalgia or other autoimmune disease. Generalized symptomatic OA in lower extremity joints other than the knees, inflammatory joint disease, bursitis, OA in the hips, or other condition that may interfere with study assessments.

Ages Eligible for Study
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Minimum Age: 40 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>ActaVisc | Other: ActaVisc and ActaVisc Mx Intra-articular Injection<br>* ActaVisc is a hyaluronan based device intended to alleviate the pain associated with osteoarthritis of the knee with a single injection and ActaVisc Mx is the same material combined with a corticosteroid.<br>|
| Experimental: 2<br>ActaVisc Mx Intra-articular Injection | Other: ActaVisc and ActaVisc Mx Intra-articular Injection<br>* ActaVisc is a hyaluronan based device intended to alleviate the pain associated with osteoarthritis of the knee with a single injection and ActaVisc Mx is the same material combined with a corticosteroid.<br>|
| Placebo Comparator: 3<br>Saline | Other: ActaVisc and ActaVisc Mx Intra-articular Injection<br>* ActaVisc is a hyaluronan based device intended to alleviate the pain associated with osteoarthritis of the knee with a single injection and ActaVisc Mx is the same material combined with a corticosteroid.<br>|
| Active Comparator: 4<br>Corticosteroid | Other: ActaVisc and ActaVisc Mx Intra-articular Injection<br>* ActaVisc is a hyaluronan based device intended to alleviate the pain associated with osteoarthritis of the knee with a single injection and ActaVisc Mx is the same material combined with a corticosteroid.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in the WOMAC Pain subscale average score for the treatment knee. |  | 26 weeks post treatment |