Effectiveness of Stromal Vascular Fraction (SVF) and Platelet-Rich Plasma (PRP) in Patients With Knee Osteoarthritis: Protocol for a Phase 3, Prospective, Randomized, Controlled, Multicenter Study (SPOST Study).

Early human evidence such as case series or small samples is exploring possible benefits.

• Level A · Stronger Clinical Evidence
• Level B · Emerging clinical evidence with positive signals
• Level C · Early human research exploring benefits
• Level D · Scientific groundwork from lab and animal studies
• Emerging · Emerging topic under active research

Abstract (original English)

Background Available evidence on the conservative treatment of knee osteoarthritis still leaves questions about the efficacy of platelet-rich plasma (PRP) and whether stromal vascular fraction (SVF) offers a superior therapeutic tool. Objective This study aims to assess the clinical efficacy of SVF as adjuvant therapy to PRP on functionality and tissue regeneration for knee osteoarthritis. Methods In a multicenter, randomized, triple-blind, controlled trial, 108 individuals with knee osteoarthritis will be block-randomized in a 1:1 ratio. Patients will receive an initial single PRP or PRP + SVF injection followed by PRP doses at 1 month and 2 months. The primary endpoint is functional improvement measured with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at the 6-month follow-up. Secondary endpoints, collected at the 1-month, 2-month, 3-month, 6-month, and 12-month follow-ups, will include the pain visual analogue scale during maximal physical activity, WOMAC score, length of time to return to work and sports in days, magnetic resonance imaging (MRI)-based Whole-Organ Magnetic Resonance Imaging Score (WORMS), Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score, MRI Area Measurement and Depth and Underlying Structures (AMADEUS) score at 6 months and at 12 months, adverse events, and serious adverse events. Results Participant re

Evidence level

Early human evidence such as case series or small samples is exploring possible benefits.

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