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

Queen Savang Vadhana Memorial Hospital, Thailand

Status and phase: Completed; Phase 3; Phase 2

Conditions: Osteo Arthritis Knee

Treatments: Drug: Leukocyte-poor platelet-rich plasma; Drug: Leukocyte-rich platelet-rich plasma; Drug: Corticosteroid

Study type: Interventional

Funder types: Other

Identifiers

NCT05737173

023/2563

Details and patient eligibility

About

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

Full 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

Enrollment: 93 patients

Sex: All

Ages: 50 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

93 participants in 3 patient groups

Leukocyte-rich platelet-rich plasma

Experimental group

Description:

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.

Treatment:

Drug: Corticosteroid

Drug: Leukocyte-poor platelet-rich plasma

Leukocyte-poor platelet-rich plasma

Experimental group

Description:

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.

Treatment:

Drug: Corticosteroid

Drug: Leukocyte-rich platelet-rich plasma

Corticosteroid

Experimental group

Description:

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

Treatment:

Drug: Leukocyte-rich platelet-rich plasma

Drug: Leukocyte-poor platelet-rich plasma