Coxarthrosis
Conditions
Keywords
platelet-rich plasma (PRP), hyaluronic acid (Hylan G-F 20)., NSAIDs, WOMAC
Brief summary
To evaluate the efficacy and safety of platelet rich plasma (PRP) in patients with coxarthrosis who don´t respond to treatment with NSAIDs, compared to treatment with hyaluronic acid (Hylan G-F 20).
Interventions
DRUGPlatelet rich plasma
Platelet rich plasma (PRP) is a platelet concentrated obtained from autologous blood centrifugation. This concentration technique provides larger amounts of biologically active molecules, mainly growth factors that are responsible for tissue repair. PRP (platelet rich plasma) contains a higher concentration of platelets from baseline (150,000-350,000 / ul).
DRUGHylan G-F 20
Hylan G-F 20 is a viscous, sterile and non-pyrogenic elasto fluid containing hylan. Hylans are byproducts from hyaluronate (hyaluronic acid sodium salt), consisting of repeating disaccharides of N-acetylglucosamine and sodium glucuronate. Hylan G-F 20 replaces and supplements the synovial fluid. It is effective at any stage of the joint pathology.
Sponsors
Fundación Pública Andaluza Progreso y Salud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients\> 30 years. * Patients who voluntarily express their intention to participate by informed consent. * Diagnosis of coxarthrosis who have failed conservative treatments for 6 months * Women of childbearing potential must have a negative pregnancy test during screening and must agree to use adequate contraception (or two contraceptive methods, of which one is barrier) while participating in the trial.
Exclusion criteria
* Treatment with infiltrations 3 months prior to the study * Prior treatment with NSAIDs 24h prior to extraction * Pre-Surgical Treatment of Hip affects * Diabetics * Severe liver or kidney disease at the time of extraction * Thrombocytopenia (\<100,000 platelets / ml) at baseline * Anemia (Hb 9 \<mg / dl) at baseline * Hyaluronic acid Allergy * History crystal arthropathy, inflammatory arthritis or neuropathic arthropathy. * Acetabular protrusions * History of infectious arthritis * Excessive deformity (acetabular dysplasia, Perthes)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EVA scale for pain measure. | Through study completion, an average of 1 year. | The patient assesses the sensation of pain following a horizontal visual analog scale (EVA) with values between 0 (no pain) and the value 100 (excruciating pain). The records taken are recorded in the medical record of the patient. |
| Harris Hip Score for pain, function and range of motion measure. | Through study completion, an average of 1 year. | It is a questionnaire developed to evaluate hip surgery or replacement. It is widely used for evaluation of hip disorders and treatment methods. |
| WOMAC questionnaire for pain, stiffness and joint mobility measure. | Through study completion, an average of 1 year. | It is a standardized questionnaire, widely used for assessment of both knee and hip osteoarthritis. It consists of five items for assessing pain (range 0-20), two items that assess the stiffness (range 0-8) and 17 items that evaluate the functionality of the joint (range 0-68). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse events. | Through study completion, an average of 1 year. | All adverse events (AEs) are recorded in the case report data from the time that the patient sign the informed consent, indicating the nature of adverse events and their description in both: the experimental group and the comparator. |
Countries
Spain
Outcome results
None listed