Intraarticular Leukocyte-rich and Leukocyte-poor PRP for Osteoarthritis of the Knee

Osteo Arthritis Knee Clinical Trial

— PRP  

Official title:

Comparison Efficacy of Intraarticular Knee Injection in Knee Osteoarthritis With Leukocyte-rich and Leukocyte-poor Platelet-rich Plasma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05737173
• Other study ID #: 023/2563
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: August 3, 2020
• Est. completion date: October 1, 2022

Study information

• Verified date: February 2023
• Source: Queen Savang Vadhana Memorial Hospital, Thailand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the efficacy of intraarticular knee injection between leukocyte-rich and leukocyte-poor platelet-rich plasma in knee osteoarthritis treatment

Description:

Participants were randomized into 3 groups (leukocyte-rich platelet-rich plasma (LR-PRP), leukocyte-poor platelet-rich plasma (LP-PRP), and Corticosteroid (CS)). The primary outcome of this study is The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and was measured pre-treatment and post-treatment at follow-up at 1, 3, and 6 months

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: October 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 99 Years

Eligibility

Inclusion Criteria:

• Age greater than or equal to 50 years old, Plain radiographs knee AP shows Kellgren-Lawrence classification 1-4, Refuse the use of NSAIDs for 2 weeks.

Exclusion Criteria:

• 1) Previous intra-articular injection therapy in the past 6 months; 2) Previously treated with intra-knee PRP injection; 3) History of knee arthritis from other causes such as rheumatoid arthritis, pseudogout or infectious joints 4) History of blood disorder including anemia and thrombocytopenia (Hb < 12 g/dl, plt < 150,000/ml ) 5) History of surgery on the aforementioned knee 6) Obvious knee deformity (valgus > 15, varus > 20, flexion ROM < 90 , extension lag > 20) 7) Pregnancy and lactation

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Leukocyte-rich platelet-rich plasma
Intra-articular knee injection
• Leukocyte-poor platelet-rich plasma
Intra-articular knee injection
• Corticosteroid
Intra-articular knee injection

Locations

Country	Name	City	State
Thailand	Queen Savang Vadhana Memorial Hospital	Si Racha	Chonburi

Sponsors (1)

Lead Sponsor	Collaborator
Queen Savang Vadhana Memorial Hospital, Thailand

Country where clinical trial is conducted

Thailand, 

References & Publications (14)

Abbas A, Du JT, Dhotar HS. The Effect of Leukocyte Concentration on Platelet-Rich Plasma Injections for Knee Osteoarthritis: A Network Meta-Analysis. J Bone Joint Surg Am. 2022 Mar 16;104(6):559-570. doi: 10.2106/JBJS.20.02258. — View Citation

Amarase C, Tanavalee A, Veerasethsiri P, Ngarmukos S. Outcome measurements following total knee arthroplasty. JRCOST 2015;39:35-42.

Ayhan E, Kesmezacar H, Akgun I. Intraarticular injections (corticosteroid, hyaluronic acid, platelet rich plasma) for the knee osteoarthritis. World J Orthop. 2014 Jul 18;5(3):351-61. doi: 10.5312/wjo.v5.i3.351. eCollection 2014 Jul 18. — View Citation

Bennell KL, Hunter DJ, Paterson KL. Platelet-Rich Plasma for the Management of Hip and Knee Osteoarthritis. Curr Rheumatol Rep. 2017 May;19(5):24. doi: 10.1007/s11926-017-0652-x. — View Citation

Dai WL, Zhou AG, Zhang H, Zhang J. Efficacy of Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis: A Meta-analysis of Randomized Controlled Trials. Arthroscopy. 2017 Mar;33(3):659-670.e1. doi: 10.1016/j.arthro.2016.09.024. Epub 2016 Dec 22. — View Citation

Di Martino A, Boffa A, Andriolo L, Romandini I, Altamura SA, Cenacchi A, Roverini V, Zaffagnini S, Filardo G. Leukocyte-Rich versus Leukocyte-Poor Platelet-Rich Plasma for the Treatment of Knee Osteoarthritis: A Double-Blind Randomized Trial. Am J Sports — View Citation

Huang Y, Liu X, Xu X, Liu J. Intra-articular injections of platelet-rich plasma, hyaluronic acid or corticosteroids for knee osteoarthritis : A prospective randomized controlled study. Orthopade. 2019 Mar;48(3):239-247. doi: 10.1007/s00132-018-03659-5. — View Citation

Kabiri A, Esfandiari E, Esmaeili A, Hashemibeni B, Pourazar A, Mardani M. Platelet-rich plasma application in chondrogenesis. Adv Biomed Res. 2014 Jun 25;3:138. doi: 10.4103/2277-9175.135156. eCollection 2014. — View Citation

Kuptniratsaikul V, Tosayanonda O, Nilganuwong S, Thamalikitkul V. The epidemiology of osteoarthritis of the knee in elderly patients living an urban area of Bangkok. J Med Assoc Thai. 2002 Feb;85(2):154-61. — View Citation

Meheux CJ, McCulloch PC, Lintner DM, Varner KE, Harris JD. Efficacy of Intra-articular Platelet-Rich Plasma Injections in Knee Osteoarthritis: A Systematic Review. Arthroscopy. 2016 Mar;32(3):495-505. doi: 10.1016/j.arthro.2015.08.005. Epub 2015 Oct 1. — View Citation

Parrish WR, Roides B. Physiology of blood components in wound healing: an appreciation of cellular co-operativity in platelet rich plasma action. J Exerc Sports Orthop 2017;4:1-14.

Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x. — View Citation

Riboh JC, Saltzman BM, Yanke AB, Fortier L, Cole BJ. Effect of Leukocyte Concentration on the Efficacy of Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis. Am J Sports Med. 2016 Mar;44(3):792-800. doi: 10.1177/0363546515580787. Epub 2015 Apr 2 — View Citation

Uslu Guvendi E, Askin A, Guvendi G, Kocyigit H. Comparison of Efficiency Between Corticosteroid and Platelet Rich Plasma Injection Therapies in Patients With Knee Osteoarthritis. Arch Rheumatol. 2017 Nov 2;33(3):273-281. doi: 10.5606/ArchRheumatol.2018.66 — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	a self-administered questionnaire consisting of 24 items divided into 3 subscales; Pain (5 items) Stiffness (2 items) Physical Function (17 items)	6 months
Secondary	VAS pain	total of 10 score	6 months
Secondary	the time up and go test	unit: second	6 months
Secondary	30-second chair stand test	unit second	6 months