A new distractable implant for vertebral body replacement: biomechanical testing of four implants for the thoracolumbar spine

Abstract

Expandable titanium implants for vertebral body replacement in the thoracolumbar spine have been well established in the reconstruction of the anterior spinal column. Load transfer at the bone-implant interface remains a point of concern. The purpose of the study was to compare the performance in axial load transfer from the implant to the vertebral body in four different implants, all of them in clinical use to date. We tested a second generation implant (Synex II) in comparison to three different expandable titanium cages: Synex I, Obelisc and X-Tenz. Twenty-four intact fresh frozen human lumbar vertebrae (L1-L4) were distributed into four identical groups according to bone mineral density (BMD). The BMD was determined by quantitative computed tomography (qCT). Specimens were loaded in craniocaudal direction with a material testing machine (Mini Bionix II) at a constant speed of 5 mm/min. Load displacement curves were continuously recorded for each specimen until failure (diminishment of compressive force (F) and/or obvious implant migration through the vertebral body end plate). One-way analysis of variance (ANOVA) and post-hoc tests (Bonferroni) were applied to detect differences at 1, 2, 3, and 4 mm displacement (F (1-4 mm)) between implant groups. No significant differences were observed with regard to maximum compression force (F (max)) and displacement (d (max)) until failure: Synex II (1,782.3 N/4.67 mm); Synex I (1,645.3 N/4.72 mm); Obelisc (1,314.0 N/4.24 mm); X-Tenz (1470.3 N/6.92 mm). However, the mean compression force at 1-4 mm displacement (F (1-4 mm): 300-1,600 N) was highest for Synex II. The difference at 2 mm displacement was significant (p = 0.028) between Synex II (F (2 mm) = 879 N) and X-Tenz (F (2 mm) = 339 N). The modified end plate design of Synex II was found to perform comparably at least with regard to the compressive performance at the implant-bone interface. The risk of the new implant for collapse into the vertebral body might be reduced when compared to the competitors.