Osteoarthritis Musculoskeletal Diseases Osteoarthritis
Conditions
Interventions
Patients were randomized into two groups using a computer-generated randomization list which was not accessible to the physicians and nurses who were involved in the patient care and management. Half
during the intake, approximately 1-2 days before the surgery (V2)
and during or shortly before knee surgery (V3), about 12 h after the last dose of Pycnogenol®. On the day of the surgery residual knee cartilage and synovial fluid were also collected. There was no fu
Sponsors
Horphag Research LTD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or over 2. Severe knee osteoarthritis according to the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score 3. Scheduled for an elective arthroplasty (Kellgren-Lawrence grade III-IV)
Exclusion criteria
Exclusion criteria: 1. Taking Non-steroidal anti-inflammatory drugs (NSAIDs) or glucocorticoids within the past four weeks 2. Currently received a therapy with anti-coagulants 3. Tested positive for HIV, HCV or HCB 4. Have had a previous or current infection of the affected knee joint
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detection and quantification of constituents and/or metabolites of Pycnogenol in serum, blood cells (before and after intake of Pycnogenol; V1, V2, V3) and synovial fluid (at the time of knee surgery, V3) of patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| Measurement of markers of inflammation and cartilage metabolism in the patient's serum, blood cells (before and after intake of Pycnogenol; V1, V2, V3) and synovial fluid (at the time of knee surgery, V3) of patients, e.g. MMP-3, MMP-13, IL-1ß, ADAMTS-5. | — |
Countries
Germany
Contacts
Public ContactLothar Seefried
Outcome results
None listed