Clinical Trial to Evaluate the Use of Platelet Rich Plasma in Front Hyaluronic Acid in Coxarthrosis

Fundación Pública Andaluza Progreso y Salud74 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Coxarthrosis

Interventions

Platelet rich plasmaDRUG

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).

Hylan G-F 20DRUG

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.

Eligibility

Sex: ALLMin age: 30 Years

Medical Language ↔ Plain English

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)

Locations (2)

Complejo Hospitalario de Pontevedra

Pontevedra, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

Outcomes

Primary Outcomes

EVA scale for pain measure.

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.

Time frame: Through study completion, an average of 1 year.

Harris Hip Score for pain, function and range of motion measure.

It is a questionnaire developed to evaluate hip surgery or replacement. It is widely used for evaluation of hip disorders and treatment methods.

Time frame: Through study completion, an average of 1 year.

WOMAC questionnaire for pain, stiffness and joint mobility measure.

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).

Time frame: Through study completion, an average of 1 year.

Data from ClinicalTrials.gov

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