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

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

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 Overview

• Status: Completed
• Conditions: Coxarthrosis
• Intervention / Treatment: Drug: Platelet rich plasma; Drug: Hylan G-F 20

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Pontevedra, Spain, 36002
    • Complejo Hospitalario de Pontevedra
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen Macarena

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRP (platelet rich plasma); 37 patients with coxarthrosis are treated with 6ml of PRP (platelet rich plasma), obtained from blood extracted from patients in the 20 minutes prior to infiltration thereof. For PRP administration: The injection should be performed at room temperature.; The administration should be carried out under aseptic conditions.; The patient will be placed in the supine position and the administration will be performed by an anterolateral approach.; The PRP is injected into the synovial space.	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).; Other Names: PRP
Active Comparator: Hylan G-F 20 (Synvisc-One ®); 37 patients with coxarthrosis are treated with a pre-filled syringe of hyaluronic acid 60mg / 6ml (Synvisc-One ®). It is necessary to remove synovial fluid before injecting Hylan G-F 20.; The injection should be performed at room temperature.; The administration should be carried out under aseptic conditions.; The patient will be placed in the supine position and the administration will be performed by an anterolateral approach.; The Hylan G-F 20 is injected into the synovial space.; After injecting Hylan G-F 20 the patient should stand 5 minutes.	Drug: 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.; Other Names: Synvisc-One

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Fundación Pública Andaluza Progreso y Salud
• Investigators: Principal Investigator: Luis Javier Roca Ruiz, Graduate, Hospital Universitario Virgen Macarena

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: February 9, 2016
• First Submitted That Met QC Criteria: February 23, 2016
• First Posted (Estimate): February 29, 2016

Study Record Updates

• Last Update Posted (Actual): February 22, 2019
• Last Update Submitted That Met QC Criteria: February 21, 2019
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: WOMAC; NSAIDs; platelet-rich plasma (PRP); hyaluronic acid (Hylan G-F 20).
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip; Physiological Effects of Drugs; Protective Agents; Viscosupplements; Hylan
• Other Study ID Numbers: COX1985; 2014-004120-21 (EudraCT Number)