Evaluation of the synovial fluid inflammatory markers in the use of serum fraction of autologous platelet-rich fibrin, hyaluronic acid and their combination in the arthrosis of the knee joint

OrthoSera Kft.0 sites27 target enrollmentJanuary 23, 2020

ConditionsOsteoarthritis Musculoskeletal Diseases

Overview

Phase: 未知
Intervention: Not specified
Conditions: Osteoarthritis
Sponsor: OrthoSera Kft.
Enrollment: 27
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 23, 2020

End Date

April 1, 2018

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

OrthoSera Kft.

Eligibility 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

•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 \<11 g/dl) or thrombocytopenia (platelets \<100,000/µl), conditions with haemoglobin \>17 g/dl or \<11 g/dl and/or platelets \>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