Effectiveness of Stromal Vascular Fraction (SVF) and Platelets Rich Plasma (PRP) in patients with Osteoarthritis: Study protocol for a phase III, prospective, randomized, controlled multi-center study: (SPOST study). (Preprint)

BACKGROUND Available evidence on the conservative treatment of osteoarthritis still leaves the place for questioning on the efficacy of Platelet-Rich Plasma (PRP) and on whether Stromal Vascular Fraction (SVF) offers a superior therapeutic tool. OBJECTIVE To assess the clinical efficacy of SVF as adjuvant therapy to PRP on functionality and tissue regeneration for osteoarthritis. METHODS In a multi-centric, randomized, triple-blind controlled trial, 130 individuals with osteoarthritis will be block-randomized in a 1:1 ratio. Patients will receive an initial single PRP or PRP + SVF injection, followed by one- and two-months PRP doses. The primary endpoint is the functional improvement measured with the Single Assessment Numeric Evaluation (SANE) scale at 6 months follow-up. The secondary endpoints, gathered at 3, 6, and 12 months follow-up will include clinical outcomes: Low Extremity Functional Scale (LEFS) and Quick Disabilities of the Arm, Shoulder and Hand (quick-DASH) score, Pain Visual Analogue Scale (VAS) during maximal physical activity, SANE, the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) (in knee osteoarthritis cases), return to work and to sports in days; and Magnetic Resonance Imaging (MRI) AMADEUS score at 6 months and at 12 months. RESULTS Participants recruitment and data collection is expected to begin in August 2024. Final end-points will be gathered in august 2027. CONCLUSIONS The study results will provide insight into the clinical efficacy of SVF as adjuvant therapy to PRP on functionality and tissue regeneration in osteoarthritis. This trial is registered on ClinicalTrials.gov (NCT05660824) and SNCTP CLINICALTRIAL This trial is registered on ClinicalTrials.gov (NCT05660824) and SNCTP.