IRCCS Istituto Ortopedico Galeazzi, via Riccardo Galeazzi 4, 20161, Milan, Italy.
Residency Program in Orthopedics and Traumatology, University of Milan, via Festa del Perdono 7, 20122, Milan, Italy.
Knee Surg Sports Traumatol Arthrosc. 2023 Aug;31(8):3079-3090. doi: 10.1007/s00167-022-07101-4. Epub 2022 Aug 30.
Current conservative treatments for knee OA provide limited benefits, with symptoms relief for a short amount of time. Regenerative medicine approaches such as the use of microfragmented adipose tissue (mFAT) showed promising results in terms of durable effects and the possibility to enhance tissue healing and counteract the progression of the pathology. Nevertheless, up to today, the large part of clinical data about mFAT use refers to uncontrolled studies, especially in the surgical setting. The purpose of this study was to evaluate the effectiveness of mFAT applied in association with arthroscopic debridement (AD) for the treatment of knee OA, in terms of symptoms relief and tissue healing.
This study is a prospective, randomized controlled clinical trial. 78 patients affected by knee OA grade 3-4 according to KL classification were randomly assigned to AD or AD + mFAT treatment groups. Clinical, radiological and serological assessments were performed at 6 months after treatment. Additional clinical evaluation was performed at the end of the study with an average follow-up of 26.1 ± 9.5 months. VAS, KOOS, WOMAC and SF-12 were also collected at both timepoints, KSS only at 6 months.
Treatment with AD + mFAT improved functional scores at both 6 months (KOOS-PS: + 11.7 ± 20.2 vs + 24.4 ± 22.5, in AD and AD + mFAT, respectively, p = 0.024; KSS: + 14.9 ± 15.9 vs + 24.8 ± 23.5, in AD and AD + mFAT, respectively, p = 0.046) and 24-month follow-ups (KOOS-PS Functional subscale: - 2.0 ± 3.5 vs - 4.7 ± 4.2, in AD and AD + mFAT, respectively, p = 0.012). Lower T2-mapping scores were obtained in AD + mFAT-treated group in medial and lateral condyle compartments (p < 0.001). Slight increase was observed in the levels of a serum biomarker of cartilage deposition (PIIINP) in both groups at 6-month follow-up (p = 0.037).
mFAT improves functional outcome and MRI appearance when used in association with AD, therefore supporting its use in the treatment of knee OA in an arthroscopic setting.
目前，针对膝骨关节炎的保守治疗方法疗效有限，只能在短时间内缓解症状。再生医学方法，如使用微粉碎脂肪组织（mFAT），在持久效果和增强组织愈合、对抗疾病进展的可能性方面显示出良好的效果。然而，到目前为止，关于 mFAT 使用的大部分临床数据都参考了非对照研究，尤其是在手术环境中。本研究旨在评估 mFAT 联合关节镜下清创术（AD）治疗膝骨关节炎的疗效，主要从症状缓解和组织愈合两方面进行评估。
本研究为前瞻性、随机对照临床试验。78 例根据 KL 分级为 3-4 级的膝骨关节炎患者被随机分为 AD 或 AD+mFAT 治疗组。治疗后 6 个月进行临床、放射学和血清学评估。在研究结束时（平均随访 26.1±9.5 个月）进行额外的临床评估。在两个时间点都收集了 VAS、KOOS、WOMAC 和 SF-12，仅在 6 个月时收集 KSS。
AD+mFAT 治疗可改善 6 个月时的功能评分（KOOS-PS：+11.7±20.2 比+24.4±22.5，AD 和 AD+mFAT 组分别，p=0.024；KSS：+14.9±15.9 比+24.8±23.5，AD 和 AD+mFAT 组分别，p=0.046）和 24 个月随访时的功能评分（KOOS-PS 功能亚量表：-2.0±3.5 比-4.7±4.2，AD 和 AD+mFAT 组分别，p=0.012）。在接受 AD+mFAT 治疗的患者中，内侧和外侧髁间窝的 T2 映射评分降低（p<0.001）。两组患者在 6 个月随访时血清软骨沉积生物标志物（PIIINP）水平略有升高（p=0.037）。
mFAT 联合 AD 可改善膝关节功能并改善 MRI 表现，因此支持其在关节镜下治疗膝骨关节炎。
