NL-OMON34625
Completed
N/A
Hydros Joint Therapy and Hydros TA for Pain Associated with Knee Osteoarthritis; A Prospective, Multi-center, Randomized, Double-blind Feasibility Study to Evaluate the Safety and Performance of Hydros Joint Therapy and Hydros TA for Management of Pain Associated with Osteoarthritis in the Knee - COR 1.0
Carbylan BioSurgery, Inc.0 sites12 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Joint damage
- Sponsor
- Carbylan BioSurgery, Inc.
- Enrollment
- 12
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Osteoarthritis (OA) grade 2 or 3 in one knee using Kellgren\-Lawrence Grading for OA radiologically and verified within the prior 6 months.
- •a. Grade 2 defined as definite osteophytes with unimpaired joint space
- •b. Grade 3 defined as definite osteophytes with moderate joint space narrowing
- •2\. Treatment knee criteria:
- •a. WOMAC Pain subscale score of 50\-90 mm on a Visual Analogue Scale (VAS) (where 0 \<\= no pain and 100 mm \<\= worst pain) for the average of the five pain questions, and
- •b. One WOMAC Pain subscale score allowed to be below 20 mm or above 90 mm on the VAS.
- •3\. Non\-treatment knee WOMAC Pain subscale score less than or equal to 30 mm average of the five pain questions.
- •4\. Symptoms in the treatment knee for at least 12 months.
- •5\. Fully ambulatory subject (ability to perform a 15 meters walk test).
- •6\. Male and female subjects 40 through 85 years of age.
Exclusion Criteria
- •1\. Non\-treatment knee joint pain greater than 30 mm average WOMAC Pain subscale scores.
- •2\. Secondary OA resulting from rheumatoid arthritis, chondrocalcinosis, osteonecrosis, chronic fibromyalgia or other autoimmune disease.
- •3\. 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. Diagnosis is from medical history or prior xrays. Upper extremity OA is NOT excluded.
- •4\. Active infection in either knee joint or adjacent tissues or positive synovial fluid culture of any joint.
- •5\. Any contraindications for intra\-articular injection or aspiration.
- •6\. Knee surgery or trauma within 3 months prior to enrollment or planned joint surgery for the period of study duration.
- •7\. Intra\-articular steroid injection in the knee and/or use of systemic (oral) corticosteroids within 3 months prior to enrollment. Inhaled steroids are NOT excluded.
- •8\. Intra\-articular hyaluronan injection in the treatment knee within 6 months prior to enrollment.
- •9\. BMI greater than 35\.
- •10\. Known hypersensitivity/allergic/anaphylactic reactions to local anesthetics.
Outcomes
Primary Outcomes
Not specified
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