Comparison of Autologous Platelet-rich Plasma With Hyaluronic Acid for the Treatment of Osteoarthritis of the Knee Joint
Study Details
Study Description
Brief Summary
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 |
|---|---|---|
|
Phase 3 |
Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PRP group Patients randomized to this group of treatment will receive 1 blinded knee intra-articular injections of autologous Platelet-Rich Plasma (3ml). |
Biological: PRP
3ml of PRP
Other Names:
|
| 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 Names:
|
Outcome Measures
Primary Outcome Measures
- Change from baseline in International Knee Documentation Committee subjective score at week 24 [Baseline, Week 24]
International Knee Documentation Committee subjective score for both groups
Secondary Outcome Measures
- Change from baseline in VAS (Visual Analogue scale) for pain during walking [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 [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 [Week 6, Week 12, Week 24]
All adverse events included
- Change from baseline in Samsung Medical Center Patellofemoral score (SMC patellofemoral score) [Baseline, Week 6, Week 12, Week 24]
Samsung Medical Center Patellofemoral score for both groups of treatment
- Patient global assessment [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 [Baseline, Week 6, Week 12]
International Knee Documentation Committee subjective score for both groups
Other Outcome Measures
- Level of white blood cell count of platelet rich plasma [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 [baseline]
Assessment of level of platelet of platelet rich plasma
- Level of growth factors of platelet rich plasma [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)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients with osteoarthritis of knee (by American College of Rheumatology Criteria) and Kellgren-Lawrence grade I ~ III
-
More than 40 out of 100-mm VAS scale for pain at screening and baseline
-
Participant is willing and able to give informed consent for participation in the study
Exclusion Criteria:
-
Patients with Hb values < 10 g/dl and platelet values < 100,000/ul
-
Patients with a current or medical history of autoimmune disease
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Recent fever ( within 2 weeks) or serious illness
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Local infection at the site of the procedure
-
Corticosteroid injection at treatment site within 1 month
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Systematic use of corticosteroids within 2 weeks
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Female participants who are pregnant, lactating or planning pregnancy during the course of the study
-
Patients who have been administered with immunosuppressants within the past 6 weeks
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Patients who are enrolled in any other clinical trials within 4 weeks
-
Patients who the principal investigator considers inappropriate for participation in the clinical trial for reasons other than those listed above
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Samsung Medical Center | Seoul | Korea, Republic of | 135-710 |
Sponsors and Collaborators
- Samsung Medical Center
Investigators
- Principal Investigator: Chul-WOn Ha, MD, PhD, Samsung Medical Center, Sungkyunkwan University School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
- Cerza F, Carnì 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.
- 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.
- Spaková T, Rosocha J, Lacko M, Harvanová 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.
- 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.
- 2013-12-056