Joint Degeneration Osteoarthritis
Conditions
Interventions
Subjects will be treated with one 6mL intra-articular injection with either
Hydros, Hydros-TA or Triamcinolone acetonide (10mg)
Hydros is a 6mL intra-articular injectable comprised of a bioresorbab
Sponsors
Carbylan Therapeutics, Inc
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Have radiographic evidence within the prior 6 months, as shown in the radiology reports, of OA grade 2 or 3 in one knee using Kellgren-Lawrence Grading for OA, and verified by the enrolling physician. a. Grade 2 defined as definite osteophytes with unimpaired joint space. b. Grade 3 defined as definite osteophytes with moderate joint space narrowing. 2. Subjects are required to be on routine pain medication (at least 5 of the last 7 days) at screening. 3. Treatment knee criteria: a. WOMAC Pain subscale score of 4-8 points on a NRS 3.1 Index (where 0= no pain and 10= worst pain) for the average of the five pain questions with routine medication for at least 5 of the last 7 days. b. An increase of 1 point at baseline (after 4 days washout) for Subjects on pain medication at screening (WOMAC Pain subscale score of 5-9 after washout). 4. Non-treatment knee average WOMAC Pain subscale score
Exclusion criteria
Exclusion criteria: 1. Non-treatment knee joint pain >3 points average WOMAC Pain subscale scores. 2. Any Subject with an increase in WOMAC A pain subscale score of 40. 12. Known hypersensitivity/allergic/anaphylactic reactions to local anesthetics. 13. Known sensitivity to corticosteroids, or hyaluronan-based products. 14. Arthroscopy of either knee or in any other joint within 3 months prior to enrollment. 15. Uncontrolled diabetes, uncontrolled hypertension or active infection end-state hepatic or renal disease; or Subjects on immunosuppressive therapy. 16. Current use of IA injections. 17. Current use of any systemic steroid therapies (oral, IV or IM), inhaled steroids are permitted. 18. Initiated a physical therapy or exercise regime within 3 months prior to enrollment. 19. Use of braces within 3 months prior to enrollment or planned use of braces for the period of study duration. 20. Clinically significant conditions that would interfere with accuracy of study evaluations including but not limited to: a. Fibromyalgia b. Chronic Fatigue Syndrome c. Gout d. Malignant neoplastic disease e. IA tumor f. Peripheral neuropathy g. Vascular insufficiency h. Hemiparesis i. Baker's cyst 20. History, diagnosis, signs or symptoms of any clinically significant psychiatric disorder, including but not limited to: a. Bipolar disorders b. Psychotic disorders c. Depression with hospital admission within last 5 years d. Suicide attempt within last 5 years e. Active alcohol/drug abuse within last 2 years f. Any other factors that the investigator feels would interfere with study evaluations and study participation 21. Subjects on anti-depressive medications for significant depression or anxiety. 22. Participation in another clinical trial and/or treatment received with any investigational agent within 30 days before enrollment. 23. Active asthma that may require periodic treatment with systemic steroid during the study period. 24. Ongoing litigation for workers compensation for musculoskeletal injuries or disorders. 25. Planned/anticipated surgery of the treatment knee during the study period. 26. Female Subjects who are pregnant and/or nursing or planning a pregnancy during the course of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study is to evaluate Hydros-TA treated Subjects for the reduction of OA symptoms, compared to Hydros at 2 weeks and Hydros-TA compared to TA 10 mg at 26 weeks, as assessed by the WOMAC OA Index. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives will include a strict OMERACT-OARSI responder rate, time of onset of pain relief, time to treatment failure, change from baseline in WOMAC A (Pain), B (Stiffness) and C (Function), change from baseline in physician and subject global assessment scores at each follow-up visit, and a rescue medication use. The safety of Hydros-TA will be evaluated by the assessment of all adverse events and through physical examinations. | — |
Countries
Netherlands
Outcome results
None listed