AzTrials
AzTrials

Osteo Arthritis KneePhase 2/3PRPNCT05737173

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

A Phase 2/3 study testing Leukocyte-rich platelet-rich plasma, Leukocyte-poor platelet-rich plasma and Corticosteroid in people with Osteo Arthritis Knee, run by Queen Savang Vadhana Memorial Hospital, Thailand at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To compare the efficacy of intraarticular knee injection between leukocyte-rich and leukocyte-poor platelet-rich plasma in knee osteoarthritis treatment Read more about this study

Who is it for?
Ages 50 to 99 years
Conditions the study is for
Osteo Arthritis Knee
What is being tested?
Leukocyte-rich platelet-rich plasma, Leukocyte-poor platelet-rich plasma and Corticosteroid
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
93 participants
Where
1 siteThailand
Study dates
3 Aug 2020to 1 Oct 2022
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Thailand1 site

  • Queen Savang Vadhana Memorial Hospital

    Si Racha, Changwat Chon Buri, 20110

Other trials in Thailand

About this study

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

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

Being tested
Leukocyte-rich platelet-rich plasma, Leukocyte-poor platelet-rich plasma, Corticosteroid
Keywords
OA knee, PRP, Leukocyte concentration, Osteoarthritis Knee
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Leukocyte-rich platelet-rich plasmaDrug

    Also called LRPRP

    Intra-articular knee injection

  • Leukocyte-poor platelet-rich plasmaDrug

    Also called LPPRP

    Intra-articular knee injection

  • CorticosteroidDrug

    Also called CS

    Intra-articular knee injection

Study groups in NCT05737173
Study groupRoleWhat they receive
Leukocyte-rich platelet-rich plasmaExperimentalLeukocyte-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.
Receives: Drug: Leukocyte-poor platelet-rich plasma; Drug: Corticosteroid
Leukocyte-poor platelet-rich plasmaExperimentalLeukocyte-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.
Receives: Drug: Leukocyte-rich platelet-rich plasma; Drug: Corticosteroid
CorticosteroidExperimentalCorticosteroid: 1 ml of triamcinolone acetonide (40mg/ml) mixed with 0.9% NaCl to a total volume of 4 ml.
Receives: Drug: Leukocyte-rich platelet-rich plasma; Drug: Leukocyte-poor platelet-rich plasma

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 6 months

Secondary outcomes (3)

  1. VAS pain

    total of 10 score

    Measured: 6 months

  2. the time up and go test

    unit: second

    Measured: 6 months

  3. 30-second chair stand test

    unit second

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2023
  2. Study start3 Aug 2020
  3. Primary completion1 Sep 2022
  4. Study completion1 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05737173
Sponsor's protocol ID
023/2563
Acronym
PRP
Status last verified
Feb 2023
First submitted
12 Feb 2023
Last updated
21 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Leukocyte-rich platelet-rich plasma, Leukocyte-poor platelet-rich plasma and Corticosteroid in people with Osteo Arthritis Knee, run by Queen Savang Vadhana Memorial Hospital, Thailand at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05737173, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in