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Completed

NCT Number: NCT05737173

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

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

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Key information

Conditions

Osteo Arthritis Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

50 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Queen Savang Vadhana Memorial Hospital

Si Racha, Changwat Chon Buri, 20110, Thailand

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Leukocyte-rich platelet-rich plasma

Drug

Intra-articular knee injection

Other names: LRPRP

Leukocyte-poor platelet-rich plasma

Drug

Intra-articular knee injection

Other names: LPPRP

Corticosteroid

Drug

Intra-articular knee injection

Other names: CS

Primary outcomes

  1. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Time frame: 6 months

    a self-administered questionnaire consisting of 24 items divided into 3 subscales

    Pain (5 items) Stiffness (2 items) Physical Function (17 items)

Secondary outcomes

  1. VAS pain

    Time frame: 6 months

    total of 10 score

  2. the time up and go test

    Time frame: 6 months

    unit: second

  3. 30-second chair stand test

    Time frame: 6 months

    unit second

Sponsors and collaborators

Lead sponsor

Queen Savang Vadhana Memorial Hospital, Thailand

Other

Registry information

Official study title

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

Acronym: PRP

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 21, 2023
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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