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

NCT ID: NCT05737173

Last Updated: 2023-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-03

Study Completion Date

2022-10-01

Brief Summary

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

Detailed Description

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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

Conditions

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Osteo Arthritis Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Leukocyte-poor platelet-rich plasma

Intervention Type DRUG

Intra-articular knee injection

Corticosteroid

Intervention Type DRUG

Intra-articular knee injection

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.

Group Type EXPERIMENTAL

Leukocyte-rich platelet-rich plasma

Intervention Type DRUG

Intra-articular knee injection

Corticosteroid

Intervention Type DRUG

Intra-articular knee injection

Corticosteroid

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

Group Type EXPERIMENTAL

Leukocyte-rich platelet-rich plasma

Intervention Type DRUG

Intra-articular knee injection

Leukocyte-poor platelet-rich plasma

Intervention Type DRUG

Intra-articular knee injection

Interventions

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Leukocyte-rich platelet-rich plasma

Intra-articular knee injection

Intervention Type DRUG

Leukocyte-poor platelet-rich plasma

Intra-articular knee injection

Intervention Type DRUG

Corticosteroid

Intra-articular knee injection

Intervention Type DRUG

Other Intervention Names

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LRPRP LPPRP CS

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Queen Savang Vadhana Memorial Hospital, Thailand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Surapol Athiprayul, MD

Role: STUDY_DIRECTOR

Queen Savang Vadhana Memorial Hospital, Thailand

Locations

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Queen Savang Vadhana Memorial Hospital

Si Racha, Changwat Chon Buri, Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type RESULT
PMID: 12081113 (View on PubMed)

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.

Reference Type RESULT
PMID: 25035839 (View on PubMed)

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.

Reference Type RESULT
PMID: 30623236 (View on PubMed)

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.

Reference Type RESULT
PMID: 30632533 (View on PubMed)

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.

Reference Type RESULT
PMID: 28012636 (View on PubMed)

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.

Reference Type RESULT
PMID: 28386761 (View on PubMed)

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.

Reference Type RESULT

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.

Reference Type RESULT
PMID: 25161985 (View on PubMed)

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.

Reference Type RESULT
PMID: 26432430 (View on PubMed)

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.

Reference Type RESULT
PMID: 1991946 (View on PubMed)

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

Reference Type RESULT

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.

Reference Type RESULT
PMID: 25925602 (View on PubMed)

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.

Reference Type RESULT
PMID: 34826301 (View on PubMed)

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.

Reference Type RESULT
PMID: 35103547 (View on PubMed)

Other Identifiers

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023/2563

Identifier Type: -

Identifier Source: org_study_id

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