almost healthy with mild osteoarthritis of the knee
Conditions
Interventions
As a utilized agents, Pentosanpolysulfat SP 54, used in this study, was manufactured and supplied in sterile injectable vials (pentosan 100mg/ml) by bene-Arzneimittel GmbH, Munich, Germany. The trea
Sponsors
Pentosan Research Society
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Symptomatic patients with primary OA of the knee affecting the tibio-femoral and/or the patello-femoral compartment were consulted by senior orthopaedic surgeons who discussed their preferred management strategy. The radiographic indications of OA were grades 1 to 2 in Koshino's classification and stages 1 to 3a in the Hokkaido University stage grading system, changing into the Kellgren-Lawrence Grading System for OA, 1957, grades 1 to 2.
Exclusion criteria
Exclusion criteria: 1. Patients who received previous intra-articular corticosteroid or another drug injection in the knee joint within the previous 3 months. 2. Patients who had other lower-extremity musculoskeletal disability or pain. 3. Patients who had pain exceeding 45 mm on a 100-mm visual analogue scale (VAS, 0- 100, 100 as worst pain) immediately following walking for 50 m. 4. Patients who had any bleeding tendency with anti-coagulant drugs (besides aspirin) having gastric or duodenal ulcer or with suspicion of alimentary tract bleeding. 5. Patients who had other severe disease or handicap (for example (i.e.), liver, kidney, and bone marrow). 6. Patients who had a past history of drug allergy. 7. Patients who were pregnant or were breastfeeding. 8. Patients who had difficulty providing us with information. 9. Patients who had difficulty with the informed consent. About using NSAIDs, the patients were not eliminated if they could have a two-week wash-out period before entering into this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All patients were prospectively reviewed at entry and at weeks 1, 2, 3, 4, 8, 12, 16, 24, and 52 with a physical examination of the knee and VAS for stiffness, pain at rest or at walking, with ROM exercises, and with walking up and down stairs. The primary outcome variable in the knee pain was measured by VAS at each visit. Blood and urine were checked including usual biochemical test and coagulation test. Weight bearing radiographs were reviewed at the baseline and at the end of study to grade the degree of OA. | — |
Secondary
| Measure | Time frame |
|---|---|
| To check the change of the metabolism in the cartilage, procollagen new synthesis (CPII) and degradation of type II Collagen (C2C) in the blood was measured with an ELISA kit, in accordance with the manufacturer's instructions, and, in addition,WOMAC 3.1 (Likert) was used to measure secondary effectiveness (pain, stiffness, physical function, social function, emotional function). | — |
Countries
Japan
Contacts
Public ContactKenji Kumagai, M.D., PhD
Nagasaki University Hospital Orthopedic Surgery
Outcome results
None listed