Radiographic and safety details of vertebral body stenting: results from a multicenter chart review

Abstract

BackgroundUp to one third of BKP treated cases shows no appreciable height restoration due to loss of both restored height and kyphotic realignment after balloon deflation. This shortcoming has called for an improved method that maintains the height and realignment reached by the fully inflated balloon until stabilization of the vertebral body by PMMA-based cementation. Restoration of the physiological vertebral body height for pain relief and for preventing further fractures of adjacent and distant vertebral bodies must be the main aim for such a method. A new vertebral body stenting system (VBS) stabilizes the vertebral body after balloon deflation until cementation. The radiographic and safety results of the first 100 cases where VBS was applied are presented.MethodsDuring the planning phase of an ongoing international multicenter RCT, radiographic, procedural and followup details were retrospectively transcribed from charts and xrays for developing and testing the case report forms. Radiographs were centrally assessed at the institution of the first/senior author.Results100 patients (62 with osteoporosis) with a total of 103 fractured vertebral bodies were treated with the VBS system. 49 were females with a mean age of 73.2 years; males were 66.7 years old. The mean preoperative anterior-middle-posterior heights were 20.3-17.6-28.0 mm, respectively. The mean local kyphotic angle was 13.1°. The mean preoperative Beck Index (anterior edge height/posterior edge height) was 0.73, the mean alternative Beck Index (middle height/posterior edge height) was 0.63. The mean postoperative heights were restored to 24.5-24.6-30.4 mm, respectively. The mean local kyphotic angle was reduced to 8.9°. The mean postoperative Beck Index was 0.81, the mean alternative one was 0.82. The overall extrusion rate was 29.1%, the symptomatic one was 1%. In the osteoporosis subgroup there were 23.8% extrusions. Within the three months followup interval there were 9% of adjacent and 4% of remote new fractures, all in the osteoporotic group.ConclusionsVBS showed its strengths especially in realignment of crush and biconcave fractures. Given that fracture mobility is present, the realignment potential is sound and increases with the severity of preoperative vertebral body deformation.

Third-generation percutaneous vertebral augmentation systems

“…The risk of adjacent vertebral fracture was estimated to be 9%, which is similar to (or slightly lower than) the rates reported in the literature for balloon kyphoplasty. We conclude that VBS can be considered a safe and effective surgical technique for the treatment of vertebral fractures and osteoporotic vertebral compression fractures with a low rate of adverse events (24)(25)(26)(27)(28).…”

“…By using ligamentotaxis, it is possible to produce a 'concrete reduction of the fracture', thus recovering the vertebral height and providing a cavity into which highly viscous poly (methylene methacrylate) (PMMA) can be injected (25,26). After the expansion phase, the balloon can be deflated and Extensive mechanical and biomechanical tests have been performed to characterize the mechanical behavior and performance of the VBS (25)(26)(27)(28). The preclinical testing of the VBS was designed to evaluate all relevant loading conditions to demonstrate a reasonable assurance of safety.…”

Stentoplasty effectiveness and safety for the treatment of osteoporotic vertebral fractures: A systematic review

“…The remainder appeared to assume the presence of osteoporosis from the presence of VCF in the absence of any other known fracture aetiology. The procedures were performed through a percutaneous transpedicular approach with two stents placed below the collapsed vertebral endplate as seen on a fluoroscopic view, except one [17] that did not inform about used method. The included studies varied in terms of internal validity.…”

“…After removing duplicates and applying the exclusion criteria, five studies were finally included [16][17][18][19][20] (Fig. 1): two clinical trials [16,20] (one non-randomized [16]) and three observational prospective [18,19] and retrospective studies [17].…”

“…Three case series studies [17][18][19] were identified about effectiveness and safety of stentoplasty, two of them [18,19] retrospectively and one [17], prospectively. No data from these studies could be pooled because of missing data and no coincidence of follow-up time intervals.…”