Percutaneous Vertebroplasty Using GeneX® in Osteoporotic Vertebral Compression Fractures: A Case Report.

Abstract

Background: 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.

Case report: 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.

Conclusion: 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.