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

NCT ID: NCT02694146

Last Updated: 2019-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2018-05-31

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).

Conditions

Coxarthrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Platelet rich plasma

Intervention Type: DRUG

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 (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.

Group Type: ACTIVE_COMPARATOR

Hylan G-F 20

Intervention Type: DRUG

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.

Interventions

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).

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

PRP; Synvisc-One

Eligibility Criteria

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)

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación Pública Andaluza Progreso y Salud

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Luis Javier Roca Ruiz, Graduate

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Virgen Macarena

Locations

Complejo Hospitalario de Pontevedra

Pontevedra, , Spain

Hospital Universitario Virgen Macarena

Seville, , Spain

Countries

Spain

Other Identifiers

2014-004120-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

COX1985

Identifier Type: -

Identifier Source: org_study_id