Comparison of Autologous Platelet-rich Plasma With Hyaluronic Acid for the Treatment of Osteoarthritis of the Knee Joint

Osteoarthritis, Knee Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02211521
• Other study ID #: 2013-12-056
• Status: Completed
• Phase: Phase 3
• First received: July 18, 2014
• Last updated: December 9, 2015
• Start date: August 2014
• Est. completion date: October 2015

Study information

• Verified date: December 2015
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Biological:
• PRP
3ml of PRP

Drug:
• Hyaluronic acid
3ml hyaluronic acid

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

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. — View 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. — View Citation

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	Level of platelet of platelet rich plasma	Assessment of level of platelet of platelet rich plasma	baseline	No
Other	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	No
Primary	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	No
Secondary	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	No
Secondary	Change from baseline in Western Ontario and McMaster Universities Arthritis Index	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	No
Secondary	Number of Participants with Adverse Events	All adverse events included	Week 6, Week 12, Week 24	Yes
Secondary	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	No
Secondary	Patient global assessment	Patient global assessment was evaluated for improvement of symptoms using 100mm VAS.	Week 6, Week 12, Week 24	No
Secondary	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	No