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Clinical Trials/NCT05737173
NCT05737173
Completed
Phase 2

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

Queen Savang Vadhana Memorial Hospital, Thailand1 site in 1 country93 target enrollmentAugust 3, 2020

Overview

Phase
Phase 2
Intervention
Leukocyte-poor platelet-rich plasma
Conditions
Osteo Arthritis Knee
Sponsor
Queen Savang Vadhana Memorial Hospital, Thailand
Enrollment
93
Locations
1
Primary Endpoint
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Status
Completed
Last Updated
3 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
August 3, 2020
End Date
October 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Queen Savang Vadhana Memorial Hospital, Thailand
Responsible Party
Sponsor

Eligibility Criteria

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

  • 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

Arms & Interventions

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.

Intervention: Leukocyte-poor platelet-rich plasma

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.

Intervention: Corticosteroid

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.

Intervention: Leukocyte-rich platelet-rich plasma

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.

Intervention: Corticosteroid

Corticosteroid

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

Intervention: Leukocyte-rich platelet-rich plasma

Corticosteroid

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

Intervention: Leukocyte-poor platelet-rich plasma

Outcomes

Primary Outcomes

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

  • the time up and go test(6 months)
  • 30-second chair stand test(6 months)
  • VAS pain(6 months)

Study Sites (1)

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