Clinical trial NCT02211521: Comparison of Autologous Platelet-rich Plasma With Hyaluronic Acid for the Treatment of Osteoarthritis of the Knee Joint
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis, Knee
Keywords: Osteoarthritis, platelet-rich plasma, hyaluronic acid
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2014-08-07
Enrollment: 110
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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
* Recent fever ( within 2 weeks) or serious illness
* Local infection at the site of the procedure
* Corticosteroid injection at treatment site within 1 month
* Systematic use of corticosteroids within 2 weeks
* 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
* 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

Primary outcomes:
measure: Change from baseline in International Knee Documentation Committee subjective score at week 24
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Change from baseline in VAS (Visual Analogue scale) for pain during walking
timeFrame: Baseline, Week 6, Week 12, Week 24
measure: Change from baseline in Western Ontario and McMaster Universities Arthritis Index
timeFrame: Baseline, Week 6, Week 12, Week 24
measure: Number of Participants with Adverse Events
timeFrame: Week 6, Week 12, Week 24
measure: Change from baseline in Samsung Medical Center Patellofemoral score (SMC patellofemoral score)
timeFrame: Baseline, Week 6, Week 12, Week 24
measure: Patient global assessment
timeFrame: Week 6, Week 12, Week 24
measure: Change from baseline in International Knee Documentation Committee subjective score at week 6, week 12
timeFrame: Baseline, Week 6, Week 12
Other outcomes:
measure: Level of white blood cell count of platelet rich plasma
timeFrame: baseline
measure: Level of platelet of platelet rich plasma
timeFrame: baseline
measure: Level of growth factors of platelet rich plasma
timeFrame: baseline
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center, Sungkyunkwan University School of Medicine
name: Chul-WOn Ha, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.