- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01697423
Comparative Assessment of Intra-articular Knee Injections of Platelet-rich Plasma (PRP) and Hyaluronic Acid in the Treatment of Knee Osteoarthritis
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: marie laure LOUIS
- Email: marielaure.louis@ap-hm.fr
Study Locations
-
-
-
Marseille, France, 13354
- Assistance Publique Hopitaux de Marseille
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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:
- Axial deformity of the lower limb over 5°
- Knee instability
- BMI < 20 or > 30
- Thrombocytopenia < 150 G/L
- Thrombopathy
- Anaemia: HB < 10g/dl
- Positive serology VIH1 and 2, Agp24, Ac HCV, Ag HbS, AcHbc, Ac HTLV I and II, TPHA
- Chronic treatment by corticosteroid per os or treatment completed more than 2 weeks before inclusion
- Intra articular knee injection of corticosteroid or completed more than 8 weeks before inclusion
- Intra articular knee injection of hyaluronic or completed more than 24 weeks before inclusion
- NSAI treatment completed more than 2 weeks before inclusion
- Fever or recent disease
- Auto immune disease
- Inflammatory Arthritis
- Immune deficit
- Infectious disease
- Pregnancy
- Patient under guardianship.
- Participation in another investigational trial within this trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: platelet-rich plasma
|
|
Active Comparator: durolane
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Variation of the functional score of WOMAC
Time Frame: 12 months
|
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.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
the evolution of pain
Time Frame: 12month
|
12month
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012-003565-18
- 2011-25 (Other Identifier: AP HM)
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