Bruno Andrea Antonio Maria, Anzillotti Giuseppe, De Donato Massimo, Basso Marco, Tamini Jacopo, Dupplicato Paolo, Kon Elizaveta, Di Matteo Berardo, Arnaldi Enrico
IRCCS Humanitas Research Hospital Rozzano Milan Italy.
Department of Biomedical Sciences Humanitas University Pieve Emanuele Milan Italy.
J Exp Orthop. 2025 Jan 17;12(1):e70144. doi: 10.1002/jeo2.70144. eCollection 2025 Jan.
Micro-fragmented adipose tissue is emerging as a promising option for the treatment of various diseases including knee osteoarthritis (OA), though clinical trials are often limited by short follow-up periods. Our aim was to evaluate the safety and clinical outcomes of an arthroscopic debridement followed by a single injection of micro-fragmented adipose tissue in patients affected by knee OA.
From 2016 to 2020, patients affected by knee OA were enroled. Micro-fragmented adipose tissue was obtained through the Lipogems® kit and intraarticularly injected after an arthroscopic debridement. Visual analogue scale for pain, Tegner score, Knee Injury and Osteoarthritis Outcome score subscales variations were assessed from baseline to 3, 6, 12, 24 and 48 months of follow-up.
Forty-one patients were evaluated up to 6 months of follow-up, 39 patients up to 24 months of follow-up and 38 patients up to 48 months of follow-up. Three underwent knee replacement surgery during the time of the study. All the clinical scores analyzed achieved statistically significant changes up to the last follow-up.
A single intra-articular knee injection of micro-fragmented adipose tissue following arthroscopic debridement is able to provide significant clinical benefits in patients affected by knee OA up to 4 years of follow-up.The present clinical study was registered on clinicaltrials.gov (no. NCT06545266).
Level IV case series.
微片段化脂肪组织正成为治疗包括膝关节骨关节炎(OA)在内的各种疾病的一种有前景的选择,不过临床试验往往受随访期短的限制。我们的目的是评估关节镜下清创术联合单次注射微片段化脂肪组织治疗膝关节OA患者的安全性和临床疗效。
2016年至2020年,纳入膝关节OA患者。通过Lipogems®套件获取微片段化脂肪组织,并在关节镜下清创术后进行关节腔内注射。评估从基线到随访3、6、12、24和48个月时的疼痛视觉模拟评分、Tegner评分、膝关节损伤和骨关节炎转归评分各子量表的变化。
41例患者接受了长达6个月的随访,39例患者接受了长达24个月的随访,38例患者接受了长达48个月的随访。3例在研究期间接受了膝关节置换手术。所有分析的临床评分在最后一次随访时均有统计学意义的变化。
关节镜下清创术后单次膝关节腔内注射微片段化脂肪组织能够在长达4年的随访期内为膝关节OA患者带来显著的临床益处。本临床研究已在clinicaltrials.gov上注册(编号:NCT06545266)。
IV级病例系列。