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

NCT02211521 | Completed Phase 3 DMC

• 1 other identifier: 2013-12-056
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis, platelet-rich plasma, hyaluronic acid

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Change from baseline in VAS (Visual Analogue scale) for pain during walking

  Baseline, Week 6, Week 12, Week 24

• Change from baseline in Western Ontario and McMaster Universities Arthritis Index

  Baseline, Week 6, Week 12, Week 24

• Number of Participants with Adverse Events

  Week 6, Week 12, Week 24

• Change from baseline in Samsung Medical Center Patellofemoral score (SMC patellofemoral score)

  Baseline, Week 6, Week 12, Week 24

• Patient global assessment

  Week 6, Week 12, Week 24

Other Outcomes (3)

• Level of white blood cell count of platelet rich plasma

  baseline

• Level of platelet of platelet rich plasma

  baseline

• Level of growth factors of platelet rich plasma

  baseline

Study Arms (2)

PRP group

EXPERIMENTAL

Patients randomized to this group of treatment will receive 1 blinded knee intra-articular injections of autologous Platelet-Rich Plasma (3ml).

Biological: PRP

Hyaloronan group

ACTIVE COMPARATOR

Patients randomized to this group of treatment will receive 1 blinded knee intra-articular injections of hyaluronic acid (3ml)

Drug: Hyaluronic acid

Interventions

PRP BIOLOGICAL

3ml of PRP

Also known as: GPS III, Biomet Biologics, Warsaw, Ind, USA

PRP group

Hyaluronic acid DRUG

3ml hyaluronic acid

Also known as: LBSA0103, 60 mg/3ml, LG Life Sciences, Korea

Hyaloronan group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Related Publications (5)

• 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.

  PMID: 23104611 BACKGROUND

• 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.

  PMID: 22513879 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.

  PMID: 21831567 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.

  PMID: 24192391 BACKGROUND

• 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.

  PMID: 33523756 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Chul-WOn Ha, MD, PhD

  Samsung Medical Center, Sungkyunkwan University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Department of Orthopaedic Surgery

Study Record Dates

• First Submitted: July 18, 2014
• First Posted: August 7, 2014
• Study Start: August 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: December 10, 2015

Record last verified: 2015-12

Locations

KR (1)