Applied Biotechnologies and Translational Medicine, University of Rome Tor Vergata, Via Montpellier 1, 00133, Rome, Italy.
Department of Orthopaedic Surgery, Sports Traumatology Unit, University of Rome Tor Vergata, Viale Oxford 81, 00133, Rome, Italy.
Knee Surg Sports Traumatol Arthrosc. 2020 Jun;28(6):1876-1884. doi: 10.1007/s00167-019-05621-0. Epub 2019 Jul 11.
To evaluate clinical outcomes over a 1-year period in patients affected by symptomatic focal chondral lesions of the knee treated with micro-fragmented stromal-vascular fraction plus microfractures compared to microfractures alone.
Two groups of 20 patients were arthroscopically treated with microfractures for a symptomatic focal chondral defect of the knee. At the end of surgery, in the experimental group, micro-fragmented stromal-vascular fraction was injected into the joint. Primary end point was WOMAC score at 12 months. Secondary end points were any adverse events, Oxford Knee Score, EQ-5D score, VAS for pain, analgesic and anti-inflammatory consumption.
All the patients were evaluated at 12-month follow-up. No adverse reactions were noted. Analgesic and anti-inflammatory consumption was similar in both groups. At 1-month follow-up, no differences were noted between groups when compared to pre-operative scores. At 3-month follow-up, patients in both groups improved from the baseline in all variables. Significantly lower VAS scores were found in the experimental group (4.2 ± 3.2 vs. 5.9 ± 1.7, p = 0.04). At 6- and 12-month follow-ups, patients in the experimental group scored better in all outcomes with a moderate effect size; in particular, better WOMAC scores were obtained at 12 months, achieving the primary end-point of the study (17.7 ± 11.1 vs. 25.5 ± 12.7; p = 0.03).
Injection of micro-fragmented stromal-vascular fraction is safe and, when associated with microfractures, is more effective in clinical terms than microfractures alone in patients affected by symptomatic focal chondral lesions of the knee. Results of the current study provide information that could help physicians to improve their counseling for patients concerning ADMSCs.
Level 1-therapeutic study.
评估接受微骨折术联合微粉碎基质血管成分注射与单纯微骨折术治疗的膝关节症状性局灶性软骨病变患者在 1 年内的临床结果。
20 例膝关节症状性局灶性软骨缺损患者行关节镜微骨折术治疗。手术结束时,实验组将微粉碎基质血管成分注射到关节内。主要终点是 12 个月时的 WOMAC 评分。次要终点是任何不良事件、牛津膝关节评分、EQ-5D 评分、疼痛 VAS 评分、镇痛药和抗炎药的使用。
所有患者均在 12 个月时进行了评估。两组均未出现不良反应。两组镇痛药和抗炎药的使用量相似。在 1 个月的随访中,与术前评分相比,两组间无差异。在 3 个月的随访中,两组患者在所有变量方面均较基线水平有所改善。实验组 VAS 评分明显较低(4.2±3.2 对 5.9±1.7,p=0.04)。在 6 个月和 12 个月的随访中,实验组患者在所有结果中的评分均较好,且具有中度的效果大小;特别是在 12 个月时获得了更好的 WOMAC 评分,达到了研究的主要终点(17.7±11.1 对 25.5±12.7;p=0.03)。
微粉碎基质血管成分注射是安全的,当与微骨折术联合应用时,与单纯微骨折术相比,在膝关节症状性局灶性软骨病变患者中更具临床疗效。本研究的结果提供了一些信息,可能有助于医生改善对患者关于 ADMSCs 的咨询。
1 级治疗研究。