Screpis Daniele, Natali Simone, Farinelli Luca, Piovan Gianluca, Iacono Venanzio, de Girolamo Laura, Viganò Marco, Zorzi Claudio
Department of Orthopaedics, IRCCS Ospedale Sacro Cuore Don Calabria, 37024 Negrar, Italy.
Clinical Ortopaedics, Department of Clinical and Molecular Sciences, Università Politecnica delle Marche, 60020 Ancona, Italy.
J Clin Med. 2022 Feb 25;11(5):1268. doi: 10.3390/jcm11051268.
The purpose of the present study was to assess, prospectively, the safety, clinical effectiveness, and feasibility of a single intra-articular injection of microfragmented adipose tissue in different stages of knee osteoarthritis (OA). The study included patients (aged 18−70 years), affected by OA (Kellgren−Lawrence I-IV). Unselected patients were evaluated before and prospectively after 6, 12, and 24 months from the injection. Visual analog scale (VAS) and knee injury and osteoarthritis outcome score (KOOS) were used for clinical evaluations. A total of 202 patients were eligible. The mean follow-up time in the cohort of patients was 24.5 ± 9.6 months. Total KOOS significantly improved from pre-operative baseline levels to 6-month follow-up (p < 0.001), and again between 6- and 12-month follow-ups (p < 0.001). The VAS showed a prompt reduction at 6 months (p < 0.001 vs. baseline), but then it increased again at 12 months compared to the 6-month assessment (p < 0.001), even though it remained lower than baseline (p < 0.001). At 24 months, patients with KL-IV demonstrated a lower improvement compared to baseline; patients that had undergone previous corticosteroid injections had a greater risk to further injection treatment. The collected clinical results suggest that MFAT may represent a safe and effective treatment for OA symptoms, offering a low-demanding and minimally invasive treatment.
本研究的目的是前瞻性地评估单次关节腔内注射微片段化脂肪组织在膝关节骨关节炎(OA)不同阶段的安全性、临床有效性和可行性。该研究纳入了年龄在18至70岁之间、患有OA(Kellgren-Lawrence I-IV级)的患者。未经过筛选的患者在注射前以及注射后6个月、12个月和24个月进行前瞻性评估。使用视觉模拟量表(VAS)和膝关节损伤与骨关节炎疗效评分(KOOS)进行临床评估。共有202例患者符合条件。患者队列的平均随访时间为24.5±9.6个月。KOOS总分从术前基线水平到6个月随访时显著改善(p<0.001),在6个月至12个月随访期间再次改善(p<0.001)。VAS在6个月时迅速降低(与基线相比,p<0.001),但与6个月评估相比,在12个月时再次升高(p<0.001),尽管仍低于基线(p<0.001)。在24个月时,KL-IV级患者与基线相比改善程度较低;既往接受过皮质类固醇注射的患者接受进一步注射治疗的风险更大。收集到的临床结果表明,微片段化脂肪组织可能是一种治疗OA症状的安全有效的方法,提供了一种低要求且微创的治疗方式。