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

Phase 2

Completed

• Conditions: Osteo Arthritis Knee
• Interventions: Drug: Leukocyte-poor platelet-rich plasma; Drug: Leukocyte-rich platelet-rich plasma; Drug: Corticosteroid

• Registration Number: NCT05737173
• Lead Sponsor: Queen Savang Vadhana Memorial Hospital, Thailand

Brief Summary

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

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

Study Timeline

• Study Start: 2020-08-03
• Primary Completion: 2022-09-01
• Study Completion: 2022-10-01
• Status Verified: 2023-02
• Study First Submitted: 2023-02-12
• Study First Submitted QC: 2023-02-12
• Last Update Submitted: 2023-02-12
• Study First Posted: 2023-02-21
• Last Update Posted: 2023-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Leukocyte-rich platelet-rich plasma	Leukocyte-poor 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.
Leukocyte-poor platelet-rich plasma	Corticosteroid	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.
Leukocyte-poor platelet-rich plasma	Leukocyte-rich 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.
Leukocyte-rich platelet-rich plasma	Corticosteroid	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.
Corticosteroid	Leukocyte-rich platelet-rich plasma	Corticosteroid: 1 ml of triamcinolone acetonide (40mg/ml) mixed with 0.9% NaCl to a total volume of 4 ml.
Corticosteroid	Leukocyte-poor platelet-rich plasma	Corticosteroid: 1 ml of triamcinolone acetonide (40mg/ml) mixed with 0.9% NaCl to a total volume of 4 ml.

Primary Outcome Measures

Name	Time	Method
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	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 Outcome Measures

Name	Time	Method
the time up and go test	6 months	unit: second
VAS pain	6 months	total of 10 score
30-second chair stand test	6 months	unit second

Trial Locations

Locations (1)

Queen Savang Vadhana Memorial Hospital; 🇹🇭 Si Racha, Chonburi, Thailand