Joint damage joint degeration
Conditions
Interventions
Hydros is an absorbable gel made of a naturally occurring substance (hyaluronic
acid). Hyaluronic acid (HA) is found in various tissues throughout the human
body, including the natural fluid in the
Sponsors
Carbylan BioSurgery, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion 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
Exclusion criteria
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. 11. Known sensitivity to avian proteins, corticosteroids, or hyaluronan-based products. 12. Arthroscopy of either knee or in any other joint within one (1) month prior to enrollment. 13. Started the use of glucosamine, chondroitin sulfate, diacerhein, or avocado/soya extracts within 2 months prior to Screening. 14. Current treatment with systemic steroids, narcotic analgesics, acetylsalicylic acid (ASA) greater than 325 mg daily, NSAIDs, COX inhibitors, or joint creams (e.g. methylsalicylate or capsaicin). NOTE: Subject may take the following during the study: a. Up to a maximum of 4 gm. paracetamol daily for treatment knee pain. b. Single daily low dose ASA up to 325 mg. c. Short term (3 days or less) NSAIDs for pain of origin other than treatment knee. 15. Current uncontrolled diabetes mellitus. 16. Current use of intra-articular injections. 17. Clinically significant conditions that would interfere with accuracy of study evaluations, e.g. malignant neoplastic disease, intra-articular tumor, fibromyalgia, peripheral neuropathy, vascular insufficiency, hemiparesis, significant psychiatric or neurological disorders, active alcohol/drug abuse, or other factors that the investigator feels would interfere with study evaluations and study participation. 18. Participation in another clinical trial and/or treatment received with any investigational agent within 30 days before enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoints Effectiveness WOMAC Pain Subscale Score The WOMAC Pain Subscale is used to assess the severity of the knee pain at Screening, Week 2 Follow-up, Week 6 Follow-up, Week 13 Follow-up, and Week 26 Follow-up visits. For each subject the scores of the five questions that comprise the WOMAC Pain subscale are averaged. The primary endpoint is the time-weighted change from baseline in the WOMAC Pain sub-scale average score in the treatment knee. Secondary analyses include the change from baseline to week 13 and change from baseline to week 26. Safety The safety and tolerability of Hydros and Hydros TA will be evaluated by comparison of Adverse Event (AE) rates. AEs will be followed through resolution or 30 days after the subject terminates from the study, whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints Positive Responders The number and percentage of subjects who have a positive response based on the OMERACT-OARSI set of responder criteria will be used to assess differences between the treatment groups in response to treatment for symptomatic primary OA of the knee over 26 weeks. Paracetamol Usage To assess differences in the amount of pain medication required over the treatment period, the average daily dosage of paracetamol (grams) will be assessed. WOMAC Function Subscale Score The WOMAC Function Subscale is used to assess the severity of the knee function at Screening, Week 2 Follow-up, Week 6 Follow-up, Week 13 Follow-up, and Week 26 Follow-up visits. For each subject the scores of the five questions that comprise the WOMAC Function subscale are averaged. WOMAC Stiffness Subscale Score The WOMAC Stiffness Subscale is used to assess the severity of the knee function at Screening, Week 2 Follow-up, Week 6 Follow-up, Week 13 Follow-up, and Week 26 Follow-up visits. For each subject the scores of the five questions that comprise the WOMAC Stiffness subscale are averaged. | — |
Countries
Netherlands
Outcome results
None listed