Comparative Assessment of Intra-articular Knee Injections of Platelet-rich Plasma (PRP) and Hyaluronic Acid in the Treatment of Knee Osteoarthritis

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Assistance Publique Hopitaux De Marseille
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01697423
First received: September 28, 2012
Last updated: August 27, 2014
Last verified: August 2014
  Purpose

The incidence of cartilage pathology has grown due to the ageing population, and the increase in sports participation and its associated trauma. The aim of the treatment of symptomatic osteoarthritis consists in reducing pain and improving the knee function in order to limit the sport, professional and social negative impact in the youngest patients.

The symptomatic treatment of knee osteoarthritis associates painkillers and non steroid anti inflammatory drugs (nsad). In case of ineffectiveness of the oral drugs intra articular injections are proposed.

Intra articular injections of hyaluronic acid are recommended by the American College of Rheumatology and the European League against Rheumatism for the treatment of knee osteoarthritis. Nevertheless their efficacy remain non predictable in patients so as the duration of clinical improvement which does not exceed 6 months.

The articular cartilage has a limited capacity for self-repair due to the low mitotic activity of chondrocytes and its avascularity.

Platelet-rich plasma is a natural concentrate of growth factors: PDGF, TGF b, IGF-1, FGF and the cytokines, liberated by platelet degranulation. The influence of these growth factors in the cartilage repair is being widely investigated in vivo and in vitro. These factors could stimulate the chondral reparation via a neovascularization, a collagen synthesis and an activation of the chondrocytes.

The hypothesis is that the intra articular injection of PRP, with its capacity to enhance articular cartilage repair, could be a therapeutic alternative to hyaluronic acid in the treatment of knee osteoarthritis resisting the oral drugs.

Material and methods: We intend to conduct a comparative, monocentric prospective randomized, double-blind study on 80 patients with symptomatic knee osteoarthritis to compare the results of 2 intra articular treatment: platelet-rich plasma and hyaluronic acid.


Condition Intervention Phase
the Treatment of Knee Osteoarthritis
Drug: platelet-rich plasma
Drug: durolane
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Comparative Assessment of Intra-articular Knee Injections of Platelet-rich Plasma (PRP) and Hyaluronic Acid in the Treatment of Knee Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • Variation of the functional score of WOMAC [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    evaluate the non inferiority between platelet-rich plasma (PRP) and hyaluronic acid. onthé evolution of the knee function, by assessing the difference with a functional score (WOMAC), before and 3 months after treatment.


Secondary Outcome Measures:
  • the evolution of pain [ Time Frame: 12month ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: October 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: platelet-rich plasma Drug: platelet-rich plasma
Active Comparator: durolane Drug: durolane

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Males and females between 20 to 75 years of age 2. Symptomatic knee arthritis 3. Axial deformity of the lower limb equal or lower than 5° 4. BMI between 20 to 30 5. Written informed consent, signed by patient or legal representative (if patient unable to sign).

    6. HB > 10g/dl 7. Negative pregnancy test

Exclusion Criteria:

  1. Axial deformity of the lower limb over 5°
  2. Knee instability
  3. BMI < 20 or > 30
  4. Thrombocytopenia < 150 G/L
  5. Thrombopathy
  6. Anaemia: HB < 10g/dl
  7. Positive serology VIH1 and 2, Agp24, Ac HCV, Ag HbS, AcHbc, Ac HTLV I and II, TPHA
  8. Chronic treatment by corticosteroid per os or treatment completed more than 2 weeks before inclusion
  9. Intra articular knee injection of corticosteroid or completed more than 8 weeks before inclusion
  10. Intra articular knee injection of hyaluronic or completed more than 24 weeks before inclusion
  11. NSAI treatment completed more than 2 weeks before inclusion
  12. Fever or recent disease
  13. Auto immune disease
  14. Inflammatory Arthritis
  15. Immune deficit
  16. Infectious disease
  17. Pregnancy
  18. Patient under guardianship.
  19. Participation in another investigational trial within this trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01697423

Contacts
Contact: marie laure LOUIS marielaure.louis@ap-hm.fr

Locations
France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Contact: MARIE LAURE LOUIS         
Principal Investigator: MARIE LAURE LOUIS         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: BERNARD BELAIGUES Assistance Publique Hopitaux De Marseille
Principal Investigator: marie laure LOUIS AP HM
  More Information

No publications provided

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01697423     History of Changes
Other Study ID Numbers: 2012-003565-18, 2011-25
Study First Received: September 28, 2012
Last Updated: August 27, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Osteoarthritis, Knee
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Viscosupplements
Protective Agents

ClinicalTrials.gov processed this record on September 16, 2014