Chen Taibang, Cui Lei, Du Di
Department of Orthopaedic Surgery of 920th Hospital of Joint Logistics Support Force, Kunming, People's Republic of China.
Int Med Case Rep J. 2025 Aug 14;18:1041-1046. doi: 10.2147/IMCRJ.S505160. eCollection 2025.
GeneX allows adsorption and aggregation of molecules and proteins to promote bone formation. According to reports in the literature, it is used in bone defect reconstruction and percutaneous vertebroplasty to promote bone formation.
We designed a prospective cohort study to evaluate the outcomes following of percutaneous vertebroplasty using GeneX in patients with osteoporotic vertebral compression fractures. Vertebroplasty was performed at seven vertebrae in the first seven patients. Overall, there were four leaks in four (57%) of the seven patients. Asymptomatic leak of the GeneX material into the intradiscal and paravertebral structures at the treated vertebral level was observed in three patients (43%). However, the material leaked into the intradural and epidural space in the seventh patient (14%), causing severe neurological deficits. Primary diagnosis was bone cement implantation syndrome. The patient's neurological status improved gradually during the month after surgery. She was able to resume her activities of daily living and had regained her urinary function by 3 months after surgery.
Owing to its physicochemical characteristics, even with sophisticated surgical techniques, GeneX cannot be recommended for use in percutaneous vertebroplasty for OVCF. The long-term safety and efficacy of GeneX need to be further validated through Phase II clinical trials. Lumbar cistern drainage can significantly improve neurological deficits in patients caused by GeneX implantation syndrome.
GeneX可使分子和蛋白质吸附与聚集，从而促进骨形成。据文献报道，它用于骨缺损重建和经皮椎体成形术以促进骨形成。
我们设计了一项前瞻性队列研究，以评估在骨质疏松性椎体压缩骨折患者中使用GeneX进行经皮椎体成形术的效果。对前7例患者的7个椎体实施了椎体成形术。总体而言，7例患者中有4例（57%）出现了4处渗漏。3例患者（43%）观察到GeneX材料无症状渗漏至治疗椎体节段的椎间盘内和椎旁结构。然而，第7例患者（14%）的材料渗漏至硬膜内和硬膜外间隙，导致严重神经功能缺损。初步诊断为骨水泥植入综合征。术后1个月内患者的神经功能状态逐渐改善。术后3个月时，她能够恢复日常生活活动并恢复了排尿功能。
由于其理化特性，即使采用复杂的手术技术，GeneX也不推荐用于骨质疏松性椎体压缩骨折的经皮椎体成形术。GeneX的长期安全性和有效性需要通过II期临床试验进一步验证。腰大池引流可显著改善GeneX植入综合征所致患者的神经功能缺损。
