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Completed

NCT Number: NCT02694146

Clinical Trial 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).

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Key information

Conditions

Coxarthrosis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Rheumatic Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Complejo Hospitalario de Pontevedra, Pontevedra, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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).

Other names: PRP

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.

Other names: Synvisc-One

Primary outcomes

  1. EVA scale for pain measure.

    Time frame: 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.

  2. Harris Hip Score for pain, function and range of motion measure.

    Time frame: 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.

  3. WOMAC questionnaire for pain, stiffness and joint mobility measure.

    Time frame: 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 outcomes

  1. Adverse events.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fundación Pública Andaluza Progreso y Salud

Other

Registry information

Official study title

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

Acronym: COX

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 29, 2016
Registry last updated
Feb 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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