Osteoarthritis Musculoskeletal Diseases
Conditions
Interventions
Before treatment, samples of synovial fluid are taken from the patient's affected knee and levels of 40 proteins are measured. This can be done if there is at least 1 ml of synovial fluid in the joint
Sponsors
OrthoSera Kft.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Early or mild arthrosis of the knee joint that complies with Kellgren-Lawrence Grade 2 or 3 on standing anteroposterior (AP) weight-bearing X-ray during the last 3 months before the enrolment. If the patient does not have a proper X-ray from the last 3 months and indicates that he/she intends to participate in the study, a current X-ray is taken and the diagnosis is made by an orthopaedic surgeon or a radiologist. 2. Aged 18 - 55 years 3. Pain indicated by the patient is at least 40 on a 0 to 100 VAS scale during the last 3 months before the enrolment and the pain is related to the arthrosis 4. Clinical assessment that the pain is caused by the arthrosis 5. Inflammatory arthropathy is not included in the medical history or it is not suspected during the assessment 6. If the patient has a liver or kidney failure, then stable condition within the last 6 months should be confirmed
Exclusion criteria
Exclusion criteria: 1. Obesity (BMI >40 kg/m²) 2. Poorly controlled diabetes (HbA1C >7.5 or fasting glucose >11.11 mmol/l in the last 6 months 3. Surgery or injury of the other knee within 6 months or corticosteroid injection within 3 months 4. Inflammatory arthropathy in the medical history (e.g. rheumatoid arthritis, systemic lupus erythematosus involving the knee joint) 5. Diagnosis of any kind of rheumatoid arthritis or gout 6. Acute infection of the involved joint or in the surroundings, or untreated active infection or inflammation in any location 7. Moderate or severe anaemia (haemoglobin 17 g/dl or 500,000/µl or <100,000 /µl 8. Dialysis or liver failure, or untreated kidney or liver failure. Patients with chronic liver or kidney failure may be enrolled if they can demonstrate that their disease has been stabilized in the last 6 months 9. Patients receiving therapeutic dose of anticoagulants (e.g. warfarin, dabigatran, enoxaparin) or patients with coagulopathy in their medical history should be excluded. Patients receiving platelet aggregation inhibitors (e.g. aspirin, clopidogrel) should not be excluded, in accordance with the clinical practice 10. Pregnant or breastfeeding. A pregnancy test with negative result should be performed on female patients with childbearing potential and they should declare that they are not breast-feeding 11. Alcohol or drug abuse 12. Uncontrolled psychiatric disorder 13. Lack of travel options (e.g. to the follow-up examinations and back) or cooperation during the visits/participation in all visits 14. Progressive or acute malignant disease 15. Haematopoietic diseases (e.g. sickle cell anaemia) 16. Population at risk: patients unable to make decisions independently about signing up for the trial, or those under external influence
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Markers of inflammation in synovial fluid measured using multiplex protein array (Luminex) technology at baseline, weeks 1 and 2, and month 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Knee joint pain assessed using a Visual Analogue Scale (VAS) at baseline, week 1, week 2, and month 6 2. Knee joint mobility assessed using the Lysholm scale at baseline, week 1, week 2, and month 6 3. Patient's assessment of the impact of their knee impairment assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS) at baseline, week 1, week 2, and month 6 | — |
Countries
Hungary
Outcome results
None listed