Long-Term Study Validates SpineJack's Effectiveness As VCF Treatment
Results from a long-term retrospective study of 178 patients have confirmed the effectiveness of Vexim's SpineJack system for treating vertebral compression fractures (VCFs).
This single-centre, retrospective, observational, consecutive study was conducted by Professor David Noriega, Orthopaedic Surgeon at the Hospital Clinico Universitario in Valladolid, Spain. The study included 178 patients suffering from VCFs due to trauma, osteoporosis or cancer tumours who were studied over the course of five years after SpineJack implantation. The intention of this retrospective analysis was to evaluate the morbidity, effect on pain and improvement of patient's autonomy, as well as the sustainability of the correction achieved over time and the consequences of this restoration on development of adjacent vertebral fractures.
Vertebral pain was assessed using a Visual Analogue Scale and showed a statistically significant decrease of 75% at the end of the observation period. Functional capacity was measured using the Oswestry Disability Index. Results showed a significant improvement of 92% at the end of the evaluation period.
In this study with an observation period of up to five years, and with almost 60% of osteoporotic fractures or fractures associated with osteoporosis, a very low rate of adjacent VCFs (2.2%) was observed. These results suggest a dramatic reduction in morbidity in VCFs treated with SpineJack. The rate of adjacent fractures published in literature on vertebroplasty and kyphoplasty is between 11 and 21%. It also confirms results from a previous international clinical study of 103 patients with VCFs due to trauma, and the results of the first retrospective study on 77 patients in France in 2013.
The SpineJack system restores a fractured vertebra to its original shape, restores the spinal column's optimal anatomy and thus removes pain and enables the patient to recover their functional capabilities. Due to a specialised range of instruments, inserting the implants into the vertebra is carried out by minimally invasive surgery, guided by X-ray, in approximately 30 minutes, enabling the patient to be discharged shortly after surgery. The SpineJack range consists of three titanium implants with three different diameters, thus covering 95% of VCFs and all patient morphologies.