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

NCT02694146 | Completed Phase 3

• 2 other identifiers: COX19852014-004120-21
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 2

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

Keywords

platelet-rich plasma (PRP); hyaluronic acid (Hylan G-F 20).; NSAIDs; WOMAC

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Adverse events.

  Through study completion, an average of 1 year.

Study Arms (2)

PRP (platelet rich plasma)

EXPERIMENTAL

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

Hylan G-F 20 (Synvisc-One ®)

ACTIVE COMPARATOR

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

Interventions

Platelet rich plasma 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).

Also known as: PRP

PRP (platelet rich plasma)

Hylan G-F 20 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.

Also known as: Synvisc-One

Hylan G-F 20 (Synvisc-One ®)

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fundación Pública Andaluza Progreso y Salud: lead

Study Sites (2)

Complejo Hospitalario de Pontevedra

Pontevedra, 36002, Spain

Location

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

hylan

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Luis Javier Roca Ruiz, Graduate

  Hospital Universitario Virgen Macarena

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2016
• First Posted: February 29, 2016
• Study Start: March 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: February 22, 2019

Record last verified: 2017-05

Locations

ES (2)