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joint diseases, knee, platelet-rich plasma, stem cells
Background: Owing to a paucity of research on minimally processed orthobiologics, we sought to investi-gate the efficacy of minimally processed bone marrow aspirate (BMA) and fat graft with a leukocyte-rich, platelet-rich plasma (PRP) intra-articular injection series on pain, function, and global rating of change (GROC) among patients with severe knee osteoarthritis (OA).
Methods: Thirty-one adults (23 females and 8 males, mean age 67 years) with clinical and radiographic evidence of knee OA (Kellgren–Lawrence ≥ 3) were included. During the initial visit, patients were exam-ined and administered the patient-specific functional scale (PSFS) and a numerical pain rating scale ranging from 0 to 10. Patients then underwent procedures to obtain 4–6 mL of PRP, a minimally processed 6 mL fat graft, and 10 mL of BMA. Patients returned twice over 6-week intervals for booster PRP injections. At each follow-up (F1 and F2), the GROC questionnaire and prior outcome measures were completed.
Results: Patients returned at an average of 41 days for the second PRP (F1) and 90 days from initial visit for the third PRP injection (F2). Friedman Chi Square analysis indicated statistically significant improvements in pain (best and worst) and PSFS from initial to F1 and F2 (P ≤ 0.001). Post hoc Wilcoxon signed-ranks analysis with Bonferroni correction identified improvement from initial to F1 and F2, as well as F1–F2 for pain, PSFS, and GROC (P ≤ 0.013). Effect sizes ranged from r = 0.32 to 0.51. Change, based on established minimum clinically important differences, indicated pain, GROC, and PSFS met thresholds at F2.
Conclusion: A minimally processed fat graft with BMA and a series of three PRP injections improved pain and function among individuals with severe knee OA who were previously recalcitrant to conservative care. Although results indicated significant improvement, clinically important change did not occur until F2. A one-arm design is a limitation of this study.