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

Coxarthrosis Clinical Trial

— COX  

Official title:

Clinical Trial Randomized, Double-blind Controlled, Phase III, to Evaluate the Use of Platelet Rich Plasma in Front Hyaluronic Acid in Coxarthrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02694146
• Other study ID #: COX1985
• Secondary ID: 2014-004120-21
• Status: Completed
• Phase: Phase 3
• Start date: March 2016
• Est. completion date: May 2018

Study information

• Verified date: May 2017
• Source: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Coxarthrosis
• Osteoarthritis, Hip

Intervention

Drug:
• Platelet 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).
• Hylan 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.

Locations

Country	Name	City	State
Spain	Complejo Hospitalario de Pontevedra	Pontevedra
Spain	Hospital Universitario Virgen Macarena	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza Progreso y Salud

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events.	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.	Through study completion, an average of 1 year.
Primary	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.	Through study completion, an average of 1 year.
Primary	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.	Through study completion, an average of 1 year.
Primary	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).	Through study completion, an average of 1 year.