Srinidhi Nagaraja1, Vivek Palepu1. 1. US Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Division of Applied Mechanics, Silver Spring, Maryland, USA.
Abstract
BACKGROUND: Screw loosening is a well-known adverse event in traditional spinal fusion instrumentation. This phenomenon may hinder segmental stability of the spine leading to bony non-union. In recent years numerous lumbar integrated fixation cages (IFC) have been introduced that offer a low profile alternative to a standard cage with an anterior plate (AP+C). The fixation approach for IFCs is different than a traditional anterior approach; therefore, it is unclear whether IFCs may loosen from the surrounding bone over time. The purpose of this study was to quantify screw loosening of IFC devices compared to AP+C implants under fatigue loading using micro-CT and image processing techniques. METHODS: L2-3 and L4-5 functional spinal units (FSUs) were obtained from nine human lumbar spines. These FSUs were then reconstructed with either AP+C or IFC implants designed to attach to vertebral bodies using four screws (two top and two bottom for AP+C; two medial and two lateral for IFC). The reconstructed specimens were fatigued in flexion-extension load of ±3 Nm at 1Hz for first 5,000 cycles and it was increased to ±5 Nm until 20,000 cycles. After removing screws to prevent image artifact, micro-CT scans were performed on all FSUs post-fatigue. These images were post-processed to calculate three-dimensional volumes around screw holes created due to damage at the screw-implant interface. RESULTS: IFC screws had significantly greater (p=0.008) screw hole volumes compared to AP+C screws after fatigue testing. This increased screw hole volume for IFC devices was mainly due to loosening in medial screws. Medial screws had significantly greater (p<0.003) screw hole volumes compared to lateral IFC screws and all AP+C screws. There was no difference (p>0.888) between the screw hole volumes of lateral IFC, top AP+C, and bottom AP+C screws. CONCLUSIONS: This study elucidated screw-loosening mechanisms in integrated fixation cages under simulated physiological loading. In particular, spatial differences in fixation was observed for IFC screws across the vertebra where medial screws loosened at a greater frequency compared to lateral screws post-fatigue. This novel technique may also be used to quantitatively investigate screw fixation post-fatigue testing in a variety of spinal devices.
BACKGROUND: Screw loosening is a well-known adverse event in traditional spinal fusion instrumentation. This phenomenon may hinder segmental stability of the spine leading to bony non-union. In recent years numerous lumbar integrated fixation cages (IFC) have been introduced that offer a low profile alternative to a standard cage with an anterior plate (AP+C). The fixation approach for IFCs is different than a traditional anterior approach; therefore, it is unclear whether IFCs may loosen from the surrounding bone over time. The purpose of this study was to quantify screw loosening of IFC devices compared to AP+C implants under fatigue loading using micro-CT and image processing techniques. METHODS: L2-3 and L4-5 functional spinal units (FSUs) were obtained from nine human lumbar spines. These FSUs were then reconstructed with either AP+C or IFC implants designed to attach to vertebral bodies using four screws (two top and two bottom for AP+C; two medial and two lateral for IFC). The reconstructed specimens were fatigued in flexion-extension load of ±3 Nm at 1Hz for first 5,000 cycles and it was increased to ±5 Nm until 20,000 cycles. After removing screws to prevent image artifact, micro-CT scans were performed on all FSUs post-fatigue. These images were post-processed to calculate three-dimensional volumes around screw holes created due to damage at the screw-implant interface. RESULTS: IFC screws had significantly greater (p=0.008) screw hole volumes compared to AP+C screws after fatigue testing. This increased screw hole volume for IFC devices was mainly due to loosening in medial screws. Medial screws had significantly greater (p<0.003) screw hole volumes compared to lateral IFC screws and all AP+C screws. There was no difference (p>0.888) between the screw hole volumes of lateral IFC, top AP+C, and bottom AP+C screws. CONCLUSIONS: This study elucidated screw-loosening mechanisms in integrated fixation cages under simulated physiological loading. In particular, spatial differences in fixation was observed for IFC screws across the vertebra where medial screws loosened at a greater frequency compared to lateral screws post-fatigue. This novel technique may also be used to quantitatively investigate screw fixation post-fatigue testing in a variety of spinal devices.
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