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

Carbylan Therapeutics, Inc.23 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Osteoarthritis

Interventions

ActaVisc and ActaVisc Mx Intra-articular InjectionOTHER

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.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (2)

Daugavpils Pilsetas Centrala Slimnica

Daugavpils, Latvia

State Hospital of Traumatology and Orthopaedics

Riga, Latvia

Outcomes

Primary Outcomes

Change from Baseline in the WOMAC Pain subscale average score for the treatment knee.

Time frame: 26 weeks post treatment

Data from ClinicalTrials.gov

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