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CompletedNCT05737173PRPUpdated Feb 21, 2023

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

A Phase 2/3 interventional study of Leukocyte-rich platelet-rich plasma and Leukocyte-poor platelet-rich plasma in Osteo Arthritis Knee, sponsored by Queen Savang Vadhana Memorial Hospital, Thailand. Completed at 1 site in Thailand. Open to participants aged 50 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-02-21.

Sponsored by Queen Savang Vadhana Memorial Hospital, Thailand · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 6 months after the study started (first participant enrolled Aug 2020, registered Feb 2023).
Phase
Phase 2/3
Study type
Interventional
Enrollment
93
Allocation
Randomized
Ages
50 Years to 99 Years
Sex
All
01

Study summary

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

Read the detailed 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

02

Conditions studied

  • Osteo Arthritis Knee

Keywords

  • OA knee
  • PRP
  • Leukocyte concentration
  • Osteoarthritis Knee
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 93 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Queen Savang Vadhana Memorial Hospital, Thailand is the lead sponsor of 29 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
93 participants (actual)

Study arms

  • Experimental
    Leukocyte-rich platelet-rich plasma

    Leukocyte-rich PRP: Centrifuge at 300 G for 5 min, separate the plasma and buffy coat layers, and then centrifuge at 700 G for 17 min with calcium chloride at the ratio of 1:5 to PRP by volume.

    Drug: Leukocyte-poor platelet-rich plasma · Drug: Corticosteroid

  • Experimental
    Leukocyte-poor platelet-rich plasma

    Leukocyte-poor PRP: Centrifuge at 123 G for 15 min, separate the plasma and buffy coat layers, and then centrifuge at 448 G for 10 min. Calcium chloride was added 1:5 to PRP by volume.

    Drug: Leukocyte-rich platelet-rich plasma · Drug: Corticosteroid

  • Experimental
    Corticosteroid

    Corticosteroid: 1 ml of triamcinolone acetonide (40mg/ml) mixed with 0.9% NaCl to a total volume of 4 ml.

    Drug: Leukocyte-rich platelet-rich plasma · Drug: Leukocyte-poor platelet-rich plasma

Interventions

  • DrugLeukocyte-rich platelet-rich plasma

    Intra-articular knee injection

    Also known as: LRPRP

  • DrugLeukocyte-poor platelet-rich plasma

    Intra-articular knee injection

    Also known as: LPPRP

  • DrugCorticosteroid

    Intra-articular knee injection

    Also known as: CS

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 6 months

Secondary outcomes

  1. VAS pain

    total of 10 score

    Time frame: 6 months

  2. the time up and go test

    unit: second

    Time frame: 6 months

  3. 30-second chair stand test

    unit second

    Time frame: 6 months

07

Study locations

1 site
  • Queen Savang Vadhana Memorial Hospital
    Si Racha, Chonburi 20110, Thailand
08

References and documents

Publications

  • 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. PubMed 12081113 ↗
  • 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. PubMed 25035839 ↗
  • 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. PubMed 30623236 ↗
  • 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.2018.6608. eCollection 2018 Sep. PubMed 30632533 ↗
  • 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. PubMed 28012636 ↗
  • 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. PubMed 28386761 ↗
  • 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.
  • 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. PubMed 25161985 ↗
  • 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. PubMed 26432430 ↗
  • 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. PubMed 1991946 ↗
  • Amarase C, Tanavalee A, Veerasethsiri P, Ngarmukos S. Outcome measurements following total knee arthroplasty. JRCOST 2015;39:35-42.
  • 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 29. PubMed 25925602 ↗
  • 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. PubMed 34826301 ↗
  • 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 Med. 2022 Mar;50(3):609-617. doi: 10.1177/03635465211064303. Epub 2022 Feb 1. PubMed 35103547 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05737173
Lead sponsor
Queen Savang Vadhana Memorial Hospital, Thailand
Responsible party
Sponsor
First posted
Feb 21, 2023
Start date
Aug 3, 2020
Primary completion
Sep 1, 2022
Completion
Oct 1, 2022
Last update
Feb 21, 2023

Study contacts

Surapol Athiprayul, MD
study director · Queen Savang Vadhana Memorial Hospital, Thailand

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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