Safety and clinical performance of kyphoplasty and SpineJack® procedures in the treatment of osteoporotic vertebral compression fractures: a pilot, monocentric, investigator-initiated study

Abstract

This pilot study showed that both techniques were safe and efficient for the osteoporotic VCF treatment. Radiological results indicate that the SpineJack® procedure has a higher potential for vertebral body height restoration and maintenance over time.

Radiological evaluation of kyphoplasty with an intravertebral expander after osteoporotic vertebral fracture

“…However, in both studies, loss of correction was observed with the SpineJack® in the follow‐up period, but was still significantly superior to the baseline value. Interestingly, no correction was achieved with BK in the study by Noriega et al In our study, a significant correction was achieved postoperatively with the SpineJack®, but the KA correction was lost and not significantly different from the baseline at the end of follow‐up.…”

“…Thereafter, the expanded implant is contained in injected cement, which stabilizes the fracture and maintains the vertebral body reduction. Since the introduction of the SpineJack®, a few clinical studies have reported superior results for the SpineJack® with regard to the restoration of VBH and correction of KA when compared with vertebroplasty and BK . However, in both studies, loss of correction was observed with the SpineJack® in the follow‐up period, but was still significantly superior to the baseline value.…”

Corpectomy and expandable cage replacement versus third generation percutaneous augmentation system in case of vertebra plana: rationale and recommendations

“…After the reduction, PMMA is injected into the vertebral body. The use of two devices symmetrically positioned inside the vertebral body allows a homogeneous spreading of the PMMA (18,19). The expansion of the device causes a preferential direction of the flow of the PMMA thus reducing the risk of leakage.…”

“…When injected, the inter-digitation of the PMMA produces a large contact area below the midline; this is essential in order to confer stability to the vertebral body. The device has a "self-locking security system" that allows to significantly reduce the risk of vertebral endplate breakage (6,19). In case of corpectomy and expandable titanium cage implant, the procedure-related complication rate is potentially higher: this approach in fact may involve severe intraoperative bleeding and long surgical times, leading to increased postoperative pain, convalescence, and risk of complications (20)(21)(22)(23)(24).…”

Vertebral augmentation with the SpineJack® in chronic vertebral compression fractures with major kyphosis

“…Numerous percutaneous techniques have then been developed to improve reduction of fractures, mainly by using intravertebral devices such as balloon kyphoplasty (BKP) [13] and more recently the SpineJack® (Vexim) [14]. The effectiveness of the Spinejack® being already established in acute OVCFs [15,16], the purpose of this study was to evaluate the feasability of vertebral augmentation with the SpineJack® in chronic OVCFs (i.e. : > 6 weeks) with important kyphosis.…”