Comparison of a Novel Posterior Integrated Transfixation Sacroiliac Joint Fusion Approach to the Posterolateral and Lateral Approaches: A Cadaveric Biomechanical and Computational Analysis of the Fixation, Invasiveness, and Fusion Area

Med Devices (Auckl). 2024 Oct 25:17:385-399. doi: 10.2147/MDER.S474734. eCollection 2024.

Abstract

Purpose: To concurrently assess and compare the fixation efficacy, invasiveness, and fusion potential of a posterior integrated transfixation cage system to the posterolateral threaded implant and lateral triangular rod systems, in a cadaveric model.

Methods and materials: Twelve (12) cadaveric sacroiliac joint specimens were utilized and tested within the single-leg stance multidirectional pure moment bending model. Each specimen was tested in the intact, destabilized, treated (using posterior, posterolateral, and lateral systems), and post-fatigue conditions by applying 0 to ± 7.5 Nm of moment in flexion-extension, axial rotation, and lateral bending while measuring the angular range of motion between the sacrum and ilium. Computational models were reconstructed from Computed Tomography (CT) scans and manufacturer surgical technique guides. The models were utilized to quantify the volume of bone removed during implantation and the surface area available for fusion.

Results: The posterior integrated transfixation cage system and the lateral triangular rods produced equivalent motion reduction in all motion planes (P > 0.583). The posterolateral cylindrical threaded implant produced less motion reductions than the posterior and lateral implants in flexion-extension (6% ± 3% vs 37% ± 10% and 33% ± 11%, respectively, P <0.05). The posterior system removed 22%-60% less bone volume from the sacrum and ilium (P<0.10), introduced 200%-270% more implant surface to the joint space (P<0.01) and decorticated 75%-375% more joint surface area (P<0.01).

Conclusion: The posterior integrated transfixation single-implant cage system is superior to the posterolateral cylindrical threaded single-implant system. Its performance in osteopenic bone is equivalent to the lateral triangular rod system in healthy bone; however, the posterior integrated transfixation cage system requires a single implant, while the lateral triangular rod system requires three. The posterior implant removes the least bone volume and has the most surface area for fusion, providing a significantly better opportunity for robust sacroiliac joint arthrodesis.

Keywords: arthrodesis; bone volume; durability; fatigue; integrated fixation; sacroiliac joint fusion.

Grants and funding

This study was funded by Vyrsa Technologies. Test implant and instrumentation were provided by Vyrsa Technologies. ORR, JHT, SM and JML are employees of Medical Device Development and their institution received support to conduct this research. AE: Medical advisory board Nevro, Medtronic, Vertos and consultant for Painteq. BAH: Consultant for Nevro and Novo Source Orthopedics. DPB: Consultant for Nevro, Genesys, CornerLoc, Spinal Simplicity, PainTEQ, SI Bone, and Wenzel Spine and has received research funding from Nevro. DLC is an employee of Nevro Corporation.