A Phase 2 interventional study of platelet-rich plasma and durolane in the Treatment of Knee Osteoarthritis, sponsored by Assistance Publique Hopitaux De Marseille. Completed at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-04-21.
Sponsored by Assistance Publique Hopitaux De Marseille · Phase 2, Interventional, and Treatment
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.
4,397 studies on the registry are indexed under Osteoarthritis; 581 are open to participants now.
This study's enrollment of 58 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 146 are open to participants now.
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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).
Exclusion Criteria:
Drug: platelet-rich plasma
Drug: durolane
Variation of the functional score of WOMAC
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.
Time frame: 12 months
the evolution of pain
Time frame: 12month
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Assistance Publique Hopitaux De Marseille