Osteoarthritis Musculoskeletal Diseases Arthrosis, unspecified
Conditions
Interventions
Seventy two patients with unilateral symptomatic knee OA were involved in a post-authorization open-label study. Patients treated with chondroitin sulfate (CS
800 mg/day) were evaluated 5 times from D-30 to 6 months.
Sponsors
Bioiberica S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients of both sexes and over 40 years of age diagnosed with unilateral symptomatic osteoarthritis of the knee who met the criteria of the American College of Rheumatology (ACR) 2. Patients who were rated grade II or III on the Kellgren and Lawrence radiological scale 3. Patients with symptomatic osteoarthritis with a pain in the knee > 40 mm on a Visual Analogue Scale (VAS) for pain assessment
Exclusion criteria
Exclusion criteria: 1. Women who were pregnant or breastfeeding. 2. Patients with any form of decompensated or uncontrolled heart disease, diagnosed with renal or liver failure, severe infections, decompensated asthma, or a history of either alcoholism or another drug addiction and/or uncontrolled active psychiatric disorder. 3. Patients who were grade I or IV on the Kellgren and Lawrence radiological scale. 4. Patients with bilateral symptomatic knee osteoarthritis or symptomatic and developing osteoarthritis in 3 or more joints, including the knee targeted in the study. 5. Patients who have had a prosthesis replaced in the 12 months prior to inclusion. 6. Concurrent joint rheumatisms (history and/or presence of signs at the time of selection) that could give rise to a misinterpretation of the evaluation of efficacy against pain or interfere in the evaluation, such as chondrocalcinosis, Paget’s disease of the limb which is ipsilateral in relation to the affected knee, rheumatoid arthritis, aseptic osteonecrosis, gout, septic arthritis, ochronosis, acromegaly, hemochromatosis, Wilson’s disease, osteochondromatosis, seronegative spondiloarthropathy, mixed conjunctival tissue disease, collagen vascular disease, psoriasis, inflammatory bowel disease. 7. Fibromyalgia patients. 8. Patients who performed intense physical activity. 9. Patients with an osteotomy in the study knee. 10. Arthroscopy in the previous 3 months. 11. Patients with a contraindication for the use of chondroitin sulphate. 12. Patients who have used hyaluronic acid (intra-articular hyaluronic acid in the affected knee) during the 26 weeks prior to inclusion. 13. Patients who have received intra-articular corticoid infiltrations in either of their hips or knees in the three months prior to the intervention. 14. Patients who had received oral corticoids in the three months prior to starting the study. 15. Patients who had taken any of the drugs classified as SYSADOA in the three months prior to the baseline visit. 16. Patients who had taken oral and/or topical NSAIDs (including COXIBs) at anti-inflammatory doses during the 30 days prior to the baseline visit. 17. Patients who had used medicinal plants or homeopathic products and analgesic creams or gels during the week prior to inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage relative change in serum biomarkers (Coll2-1, Coll2-1NO2, Fib3-2) measured at five visits: selection visit (D-30 days), baseline visit (D0, initiation of treatment), 1-month visit, 3-month visit and 6-month visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Evaluation of pain through a visual analogue scale of 10 cm (VAS) 2. Evaluation of knee function disability measured by Lequesne Algofunctional Index Measured at five visits: selection visit (D-30 days), baseline visit (D0, initiation of treatment), 1-month visit, 3-month visit and 6-month visit. | — |
Countries
Spain
Outcome results
None listed