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

NCT05737173 | Completed Phase 2 DMC

• 1 other identifier: 023/2563
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteo Arthritis Knee

Keywords

OA knee; PRP; Leukocyte concentration; Osteoarthritis Knee

Outcome Measures

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)

  6 months

Secondary Outcomes (3)

• VAS pain

  6 months

• the time up and go test

  6 months

• 30-second chair stand test

  6 months

Study Arms (3)

Leukocyte-rich platelet-rich plasma

EXPERIMENTAL

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

Leukocyte-poor platelet-rich plasma

EXPERIMENTAL

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

Corticosteroid

EXPERIMENTAL

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

Leukocyte-rich platelet-rich plasma DRUG

Intra-articular knee injection

Also known as: LRPRP

Corticosteroid; Leukocyte-poor platelet-rich plasma

Leukocyte-poor platelet-rich plasma DRUG

Intra-articular knee injection

Also known as: LPPRP

Corticosteroid; Leukocyte-rich platelet-rich plasma

Corticosteroid DRUG

Intra-articular knee injection

Also known as: CS

Leukocyte-poor platelet-rich plasma; Leukocyte-rich platelet-rich plasma

Eligibility Criteria

• Age: 50 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \) 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

Sponsors & Collaborators

• Queen Savang Vadhana Memorial Hospital, Thailand: lead

Study Sites (1)

Queen Savang Vadhana Memorial Hospital

Si Racha, Changwat Chon Buri, 20110, Thailand

Location

Related Publications (14)

• 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.

  PMID: 12081113 RESULT

• 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.

  PMID: 25035839 RESULT

• 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.

  PMID: 30623236 RESULT

• 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.

  PMID: 30632533 RESULT

• 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.

  PMID: 28012636 RESULT

• 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.

  PMID: 28386761 RESULT

• 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.

  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.

  PMID: 25161985 RESULT

• 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.

  PMID: 26432430 RESULT

• 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.

  PMID: 1991946 RESULT

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

  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.

  PMID: 25925602 RESULT

• 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.

  PMID: 34826301 RESULT

• 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.

  PMID: 35103547 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Surapol Athiprayul, MD

  Queen Savang Vadhana Memorial Hospital, Thailand

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2023
• First Posted: February 21, 2023
• Study Start: August 3, 2020
• Primary Completion: September 1, 2022
• Study Completion: October 1, 2022
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)