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

Sponsor

Fundación Pública Andaluza Progreso y Salud (Other)

Overall Status

Completed

CT.gov ID

NCT02694146

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Coxarthrosis	Drug: Platelet rich plasma Drug: Hylan G-F 20	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

74 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2016

Actual Primary Completion Date :

May 1, 2018

Actual Study Completion Date :

May 1, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

EVA scale for pain measure. [Through study completion, an average of 1 year.]
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.
Harris Hip Score for pain, function and range of motion measure. [Through study completion, an average of 1 year.]
It is a questionnaire developed to evaluate hip surgery or replacement. It is widely used for evaluation of hip disorders and treatment methods.
WOMAC questionnaire for pain, stiffness and joint mobility measure. [Through study completion, an average of 1 year.]
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).

Other Outcome Measures

Adverse events. [Through study completion, an average of 1 year.]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years and Older

Sexes Eligible for Study:

All

Accepts 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.