Clinical trial NCT05737173: Intraarticular Leukocyte-rich and Leukocyte-poor PRP for Osteoarthritis of the Knee
Official title: Comparison Efficacy of Intraarticular Knee Injection in Knee Osteoarthritis With Leukocyte-rich and Leukocyte-poor Platelet-rich Plasma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Osteo Arthritis Knee
Keywords: OA knee
PRP
Leukocyte concentration
Osteoarthritis Knee
Lead sponsor: Queen Savang Vadhana Memorial Hospital, Thailand
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 93
Sex: ALL
Minimum age (years): 50
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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:

* 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

Primary outcomes:
measure: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: 6 months
Secondary outcomes:
measure: VAS pain
timeFrame: 6 months
measure: the time up and go test
timeFrame: 6 months
measure: 30-second chair stand test
timeFrame: 6 months
Other outcomes:
Locations:
city: Si Racha
country: Thailand
facility: Queen Savang Vadhana Memorial Hospital
state: Chonburi
Study officials:
affiliation: Queen Savang Vadhana Memorial Hospital, Thailand
name: Surapol Athiprayul, MD
role: STUDY_DIRECTOR
References:
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citation: 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.
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