Samsung Medical Center
Seoul, 135-710, South Korea
NCT Number: NCT02211521
The purpose of this study is to compare the efficacy of platelet-rich plasma versus hyaluronic acid intra-articular injections for the treatment of osteoarthritis of knee joint.
The hypothesis is that PRP intra-articular injection is comparable or even better than hyaluronic acid injection.
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Notify Me40 year–80 year
All sexes
Interventional
Phase 3
Seoul, 135-710, South Korea
Osteoarthritis (OA) has a significant impact on our society. The limited regenerative capacity of cartilage is part of this problem. Existing degenerative lesions lead to accelerated deterioration of the articular (joint) surface leading to end-stage arthritis. In particular, the most recent knowledge regarding tissue biology highlights a complex regulation of growth factors (GFs) for the normal tissue structure and the reaction to tissue damage. The influence of GFs on cartilage repair is now widely investigated in vitro and in vivo. Platelet Rich Plasma (PRP) is a simple, low- cost and minimally- invasive method that allows one to obtain a natural concentrate of autologous GFs from the blood, and it is increasingly applied in the clinical practice to treat knee degenerative pathology, such as chondropathy and early OA. The biological rational of PRP is that platelets contain storage pools of GFs, cytokines, chemokines and many other mediators.Although its widespread application, there are little high level studies in the literature to demonstrate the real efficacy of PRP.
The investigators hypothesized that intra-articular injections of PRP to treat knee osteoarthritis could determine pain relief and recovery of knee function with overall clinical outcome comparable or even better than viscosupplementation, which is a common injective approach applied in this kind of pathology. To this purpose the investigators designed a double blind randomized controlled trial comparing PRP vs viscosupplementation.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
3ml of PRP
Other names: GPS III, Biomet Biologics, Warsaw, Ind, USA
3ml hyaluronic acid
Other names: LBSA0103, 60 mg/3ml, LG Life Sciences, Korea
Time frame: Baseline, Week 24
International Knee Documentation Committee subjective score for both groups
Time frame: Baseline, Week 6, Week 12, Week 24
VAS (Visual Analogue scale) for pain during walking for both groups of treatment
Time frame: Baseline, Week 6, Week 12, Week 24
Western Ontario and McMaster Universities Arthritis Index variation for both groups
Subscale analysis of pain, stiffness, function also contain
Time frame: Week 6, Week 12, Week 24
All adverse events included
Time frame: Baseline, Week 6, Week 12, Week 24
Samsung Medical Center Patellofemoral score for both groups of treatment
Time frame: Week 6, Week 12, Week 24
Patient global assessment was evaluated for improvement of symptoms using 100mm VAS.
Time frame: Baseline, Week 6, Week 12
International Knee Documentation Committee subjective score for both groups
Time frame: baseline
Assessment of level of WBC, platelet and several growth factors of platelet rich plasma Assessment of level of white blood cell count of platelet rich plasma
Time frame: baseline
Assessment of level of platelet of platelet rich plasma
Time frame: baseline
Assessment of level several growth factors of platelet rich plasma (platelet derived growth factor, transforming growth factor -b1, vascular endothelial growth factor, epidermal growth factor, fibroblast growth factor etc)
Samsung Medical Center
Other
Randomized, Double Blind, Comparison Clinical Trial to Test the Efficacy and Safety of Intraarticular Injection of Autologous Platelet-rich Plasma (PRP) for the Treatment of Osteoarthritis of the Knee Joint
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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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