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

Fundación Pública Andaluza Progreso y Salud

Status and phase: Completed; Phase 3

Conditions: Coxarthrosis

Treatments: Drug: Hylan G-F 20; Drug: Platelet rich plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT02694146

2014-004120-21 (EudraCT Number)

COX1985

Details and patient eligibility

About

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).

Enrollment: 74 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

74 participants in 2 patient groups

PRP (platelet rich plasma)

Experimental group

Description:

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.

Treatment:

Drug: Platelet rich plasma

Hylan G-F 20 (Synvisc-One ®)

Active Comparator group

Description:

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.

Treatment:

Drug: Hylan G-F 20