Comparison of Autologous Platelet-rich Plasma With Hyaluronic Acid for the Treatment of Osteoarthritis of the Knee Joint
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|ClinicalTrials.gov Identifier: NCT02211521|
Recruitment Status : Completed
First Posted : August 7, 2014
Last Update Posted : December 10, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee||Biological: PRP Drug: Hyaluronic acid||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||August 2014|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||October 2015|
Experimental: PRP group
Patients randomized to this group of treatment will receive 1 blinded knee intra-articular injections of autologous Platelet-Rich Plasma (3ml).
3ml of PRP
Other Name: GPS III, Biomet Biologics, Warsaw, Ind, USA
Active Comparator: Hyaloronan group
Patients randomized to this group of treatment will receive 1 blinded knee intra-articular injections of hyaluronic acid (3ml)
Drug: Hyaluronic acid
3ml hyaluronic acid
Other Name: LBSA0103, 60 mg/3ml, LG Life Sciences, Korea
- Change from baseline in International Knee Documentation Committee subjective score at week 24 [ Time Frame: Baseline, Week 24 ]International Knee Documentation Committee subjective score for both groups
- Change from baseline in VAS (Visual Analogue scale) for pain during walking [ Time Frame: Baseline, Week 6, Week 12, Week 24 ]VAS (Visual Analogue scale) for pain during walking for both groups of treatment
- Change from baseline in Western Ontario and McMaster Universities Arthritis Index [ 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
- Number of Participants with Adverse Events [ Time Frame: Week 6, Week 12, Week 24 ]All adverse events included
- Change from baseline in Samsung Medical Center Patellofemoral score (SMC patellofemoral score) [ Time Frame: Baseline, Week 6, Week 12, Week 24 ]Samsung Medical Center Patellofemoral score for both groups of treatment
- Patient global assessment [ Time Frame: Week 6, Week 12, Week 24 ]Patient global assessment was evaluated for improvement of symptoms using 100mm VAS.
- Change from baseline in International Knee Documentation Committee subjective score at week 6, week 12 [ Time Frame: Baseline, Week 6, Week 12 ]International Knee Documentation Committee subjective score for both groups
- Level of white blood cell count of platelet rich plasma [ 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
- Level of platelet of platelet rich plasma [ Time Frame: baseline ]Assessment of level of platelet of platelet rich plasma
- Level of growth factors 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02211521
|Korea, Republic of|
|Samsung Medical Center|
|Seoul, Korea, Republic of, 135-710|
|Principal Investigator:||Chul-WOn Ha, MD, PhD||Samsung Medical Center, Sungkyunkwan University School of Medicine|