The use of entirely synthetic solutions featuring porous titanium interbody implants and a bone graft substitute have clinical and economic advantages compared with traditional, non-porous interbody implants with premium-priced biologics. This is according to a recent study published in the Journal of Neurosurgery: Spine by Hani Malone (Scripps Clinic / San Diego Spine Foundation, San Diego, USA) et al.
The retrospective clinical study consisted of 90 patients who underwent lateral lumbar interbody fusions with the combination of a synthetic bone graft substitute, Attrax putty (NuVasive), and a porous titanium interbody implant, Modulus XLIF (NuVasive).
In total, 136 lumbar levels were treated in the 90 patients. The mean age was 69 years, and 63% of the included patients were female. Half (50%) had undergone previous spinal surgery, and a third (33.7%) had undergone prior lumbar fusion. A third (33.7%) were treated at multiple levels (mean levels per patient 1.51).
The study found that, one year after surgery, the mean improvements in patient-reported outcomes (vs preoperative scores) were −17.8 for Oswestry Disability Index (ODI) (p<0.0001), −3.1 for Visual Analogue Scale (VAS)–back pain (p<0.0001), and −2.9 for VAS–leg pain (p<0.0001).
Bone bridging and/or appositional integrity was achieved in 99.3% of patients, including 97.8% who had complete bone bridging, and no fixation loosening or implant failure was observed at any segment.
Low-grade graft subsidence (Marchi grade ≤ I) occurred in three levels (2.2%), and intraoperative endplate violation occurred twice (1.5%). High-grade subsidence was not found and no implant failure or revision surgery for pseudarthrosis/subsidence was necessary.
“Having clinically-backed Advanced Materials Science options, from synthetic biologics to porous interbody implants, gives surgeons stronger procedural offerings across the entire spine,” said Massimo Calafiore, chief commercial officer at NuVasive. “NuVasive leads with a focus on disruptive innovation—providing not only procedures that are better clinically for both patients and surgeons, but also less expensive for the hospitals we partner with.”
Attrax Putty is the first and only synthetic bone graft with US Food and Drug Administration indications for thoracolumbar interbody fusion and is also a relatively inexpensive biologic option.1 Modulus XLIF, part of the company’s Advanced Materials Science portfolio, provides a fully porous architecture and favourable environment for bone in-growth,2 supporting the less invasive XLIF procedure that is designed to be clinically and economically beneficial.
“I am excited to see outcomes that have been traditionally associated with bone morphogenetic proteins achieved with cost-effective biologics used in porous interbody cage technology,” said Robert Eastlack, orthopaedic spine surgeon at Scripps Health (San Diego, USA) and board member of the San Diego Spine Foundation. “The results of this study have created lasting change in our practices, presented huge cost savings and showed significant benefits to the patients.”
Speaking to Spinal News International, Malone said: “Spine surgery continues to evolve at a rapid pace and while innovation improves patient care, it has also contributed to an unsustainable increase in cost. By contrast, advances in implant materials science, such as 3D-printed porous titanium, can be leveraged to lower cost by reducing our reliance on expensive biologics for spinal fusion.”
1 Malone H, Mundis Jr., GM, Collier, M, et al. Can a bioactive interbody device reduce the cost burden of achieving lateral lumbar fusion? J Neurosurg Spine. Published online June 3, 2022; DOI: 10.3171/2022.4.SPINE211070.
2 Fogel G, Martin N, Lynch K, et al. Subsidence and fusion performance of a 3D-printed porous interbody cage with stress-optimized body lattice and microporous endplates – a comprehensive mechanical and biological analysis. Spine J 2022;22:1028-37.