Margaret R Van Horn1, Roland Beard2, Wenhai Wang2, Bryan W Cunningham3, Kenneth P Mullinix3, May Allall4, Brandon S Bucklen2. 1. Musculoskeletal Education and Research Center, A Division of Globus Medical, Inc., 2560 General Armistead Ave, Audubon, PA, 19403 USA. Electronic address: mvanhorn@globusmedical.com. 2. Musculoskeletal Education and Research Center, A Division of Globus Medical, Inc., 2560 General Armistead Ave, Audubon, PA, 19403 USA. 3. Musculoskeletal Research Center, Department of Orthopaedic Surgery, MedStar Union Memorial Hospital, 201 E University Pkwy, Baltimore, MD, 21218 USA. 4. School of Biomedical Engineering, Science and Health Systems, Drexel University, 3141 Chestnut St, Philadelphia, PA, 19104 USA.
Abstract
BACKGROUND CONTEXT: Osseointegration is a pivotal process in achieving a rigid fusion and ultimately a successful clinical outcome following interbody fusion surgery. Advancements in 3D printing technology permit commonly used titanium interbody spacers to be designed with unique architectures, such as a highly interconnected and specific porous structure that mimics the architecture of trabecular bone. Interbody implants with a microscale surface roughness and biomimetic porosity may improve bony ongrowth and ingrowth compared to traditional materials. PURPOSE: The purpose of this study was to compare the osseointegration of lumbar interbody fusion devices composed of surgical-grade polyetheretherketone (PEEK), titanium-alloy (TAV), and 3D-printed porous, biomimetic TAV (3DP) using an in vivo ovine model. STUDY DESIGN: In Vivo Preclinical Animal Study METHODS: Eighteen sheep underwent two-level lateral lumbar interbody fusion randomized with either 3DP, PEEK, or TAV interbody spacers (n=6 levels for each spacer per time point). Postoperative time points were 6 and 12 weeks. Microcomputed tomography and histomorphometry were used to quantify bone volume (BV) within the spacers (ingrowth) and the surface bone apposition ratio (BAR) (ongrowth), respectively. RESULTS: The 3DP-treatment group demonstrated significantly higher BV than the PEEK and TAV groups at 6 weeks (77.3±44.1 mm3, 116.9±43.0 mm3, and 108.7±15.2 mm3, respectively) (p<.05). At 12 weeks, there were no BV differences between groups (p>.05). BV increased in all groups from the 6- to 12-week time points (p<.05). At both time points, the 3DP-treated group (6w: 23.6±10.9%; 12w: 36.5±10.9%) had significantly greater BAR than the PEEK (6w: 8.6±2.1%; 12w: 14.0±5.0%) and TAV (6w: 6.0±5.7%; 12w: 4.1±3.3%) groups (p<.05). CONCLUSIONS: 3DP interbody spacers facilitated greater total bony ingrowth at 6 weeks, and greater bony ongrowth postoperatively at both 6 and 12 weeks, in comparison to solid PEEK and TAV implants. CLINICAL SIGNIFICANCE: Based on these findings, the 3DP spacers may be a reasonable alternative to traditional PEEK and TAV spacers in various clinical applications of interbody fusion.
BACKGROUND CONTEXT: Osseointegration is a pivotal process in achieving a rigid fusion and ultimately a successful clinical outcome following interbody fusion surgery. Advancements in 3D printing technology permit commonly used titanium interbody spacers to be designed with unique architectures, such as a highly interconnected and specific porous structure that mimics the architecture of trabecular bone. Interbody implants with a microscale surface roughness and biomimetic porosity may improve bony ongrowth and ingrowth compared to traditional materials. PURPOSE: The purpose of this study was to compare the osseointegration of lumbar interbody fusion devices composed of surgical-grade polyetheretherketone (PEEK), titanium-alloy (TAV), and 3D-printed porous, biomimetic TAV (3DP) using an in vivo ovine model. STUDY DESIGN: In Vivo Preclinical Animal Study METHODS: Eighteen sheep underwent two-level lateral lumbar interbody fusion randomized with either 3DP, PEEK, or TAV interbody spacers (n=6 levels for each spacer per time point). Postoperative time points were 6 and 12 weeks. Microcomputed tomography and histomorphometry were used to quantify bone volume (BV) within the spacers (ingrowth) and the surface bone apposition ratio (BAR) (ongrowth), respectively. RESULTS: The 3DP-treatment group demonstrated significantly higher BV than the PEEK and TAV groups at 6 weeks (77.3±44.1 mm3, 116.9±43.0 mm3, and 108.7±15.2 mm3, respectively) (p<.05). At 12 weeks, there were no BV differences between groups (p>.05). BV increased in all groups from the 6- to 12-week time points (p<.05). At both time points, the 3DP-treated group (6w: 23.6±10.9%; 12w: 36.5±10.9%) had significantly greater BAR than the PEEK (6w: 8.6±2.1%; 12w: 14.0±5.0%) and TAV (6w: 6.0±5.7%; 12w: 4.1±3.3%) groups (p<.05). CONCLUSIONS: 3DP interbody spacers facilitated greater total bony ingrowth at 6 weeks, and greater bony ongrowth postoperatively at both 6 and 12 weeks, in comparison to solid PEEK and TAV implants. CLINICAL SIGNIFICANCE: Based on these findings, the 3DP spacers may be a reasonable alternative to traditional PEEK and TAV spacers in various clinical applications of interbody fusion.
Authors: Andrew L Alejo; Scott McDermott; Yusuf Khalil; Hope C Ball; Gabrielle T Robinson; Ernesto Solorzano; Amanda M Alejo; Jacob Douglas; Trinity K Samson; Jesse W Young; Fayez F Safadi Journal: J Orthop Sports Med Date: 2022-09-05