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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRP group | Experimental | Patients randomized to this group of treatment will receive 1 blinded knee intra-articular injections of autologous Platelet-Rich Plasma (3ml). |
|
| Hyaloronan group | Active Comparator | Patients randomized to this group of treatment will receive 1 blinded knee intra-articular injections of hyaluronic acid (3ml) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRP | Biological | 3ml of PRP |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in International Knee Documentation Committee subjective score at week 24 | International Knee Documentation Committee subjective score for both groups | Baseline, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in VAS (Visual Analogue scale) for pain during walking | VAS (Visual Analogue scale) for pain during walking for both groups of treatment | Baseline, Week 6, Week 12, Week 24 |
| Change from baseline in Western Ontario and McMaster Universities Arthritis Index |
| Measure | Description | Time Frame |
|---|---|---|
| Level of white blood cell count of platelet rich plasma | 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 | baseline |
| Level of platelet of platelet rich plasma |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chul-WOn Ha, MD, PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 135-710 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23104611 | Background | Cerza F, Carni S, Carcangiu A, Di Vavo I, Schiavilla V, Pecora A, De Biasi G, Ciuffreda M. Comparison between hyaluronic acid and platelet-rich plasma, intra-articular infiltration in the treatment of gonarthrosis. Am J Sports Med. 2012 Dec;40(12):2822-7. doi: 10.1177/0363546512461902. Epub 2012 Oct 25. | |
| 22513879 | Background |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Hyaluronic acid | Drug | 3ml hyaluronic acid |
|
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Western Ontario and McMaster Universities Arthritis Index variation for both groups Subscale analysis of pain, stiffness, function also contain |
| Baseline, Week 6, Week 12, Week 24 |
| Number of Participants with Adverse Events | All adverse events included | Week 6, Week 12, Week 24 |
| Change from baseline in Samsung Medical Center Patellofemoral score (SMC patellofemoral score) | Samsung Medical Center Patellofemoral score for both groups of treatment | Baseline, Week 6, Week 12, Week 24 |
| Patient global assessment | Patient global assessment was evaluated for improvement of symptoms using 100mm VAS. | Week 6, Week 12, Week 24 |
| Change from baseline in International Knee Documentation Committee subjective score at week 6, week 12 | International Knee Documentation Committee subjective score for both groups | Baseline, Week 6, Week 12 |
Assessment of level of platelet of platelet rich plasma |
| baseline |
| Level of growth factors of platelet rich plasma | 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) | baseline |
| Spakova T, Rosocha J, Lacko M, Harvanova D, Gharaibeh A. Treatment of knee joint osteoarthritis with autologous platelet-rich plasma in comparison with hyaluronic acid. Am J Phys Med Rehabil. 2012 May;91(5):411-7. doi: 10.1097/PHM.0b013e3182aab72. |
| 21831567 | Background | Kon E, Mandelbaum B, Buda R, Filardo G, Delcogliano M, Timoncini A, Fornasari PM, Giannini S, Marcacci M. Platelet-rich plasma intra-articular injection versus hyaluronic acid viscosupplementation as treatments for cartilage pathology: from early degeneration to osteoarthritis. Arthroscopy. 2011 Nov;27(11):1490-501. doi: 10.1016/j.arthro.2011.05.011. Epub 2011 Aug 10. |
| 24192391 | Background | Sundman EA, Cole BJ, Karas V, Della Valle C, Tetreault MW, Mohammed HO, Fortier LA. The anti-inflammatory and matrix restorative mechanisms of platelet-rich plasma in osteoarthritis. Am J Sports Med. 2014 Jan;42(1):35-41. doi: 10.1177/0363546513507766. Epub 2013 Nov 5. |
| 33523756 | Derived | Park YB, Kim JH, Ha CW, Lee DH. Clinical Efficacy of Platelet-Rich Plasma Injection and Its Association With Growth Factors in the Treatment of Mild to Moderate Knee Osteoarthritis: A Randomized Double-Blind Controlled Clinical Trial As Compared With Hyaluronic Acid. Am J Sports Med. 2021 Feb;49(2):487-496. doi: 10.1177/0363546520986867. |