Comparison of methods for determining the presence and extent of anterior lumbar interbody fusion.

STUDY DESIGN: Titanium alloy interbody fusion devices with autogenous bone were placed in the L5-L6 disc space of 31 adult pig-tailed monkeys through an anterolateral (retroperitoneal) approach. Anteroposterior and lateral radiographs, CT imaging, and histologic analysis of the specimens were performed. OBJECTIVES: This study compared the accuracy of plain film radiographs and CT imaging for determining bony fusion of a titanium interbody device implanted in a non-human primate model. The accuracy of the assessments was determined by comparison to histologic analysis. SUMMARY OF BACKGROUND DATA: Interbody fusion assessment is often difficult to compare in clinical studies because of differences in definition of fusion criteria. In addition, the accuracy of plain film radiographs and CT imaging assessments of fusion are debated because of device material radiopacity and introduction of artifacts. METHODS: A uniform grading system evaluating both the presence and extent of bony fusion was applied to all evaluation techniques. Matched-pair nonparametric t tests were used to determine differences in scoring. RESULTS: The radiographic and histologic presence of fusion grades was equivalent in only 13 of 29 cases (45%), while the CT imaging was equivalent to histologic assessment in 24 of 29 cases (83%). However, the extent of bony fusion in CT imaging and histologic assessment was equivalent in only 4 of 29 cases (14%). Grading of CT images significantly overestimated the extent of fusion. CONCLUSIONS: This study demonstrated CT imaging techniques to be superior to plain film radiographs in determining the presence of bony fusion. However, CT imaging did not accurately determine the extent of bony fusion present as confirmed by histologic analysis.

Direct current stimulation of titanium interbody fusion devices in primates.

BACKGROUND CONTEXT: The fusion rate for anterior lumbar interbody fusion (ALIF) varies widely with the use of different interbody devices and bone graft options. Adjunctive techniques such as electrical stimulation may improve the rate of bony fusion. PURPOSE: To determine if direct current (DC) electrical stimulation of a metallic interbody fusion device enhanced the incidence or extent of anterior bony fusion. STUDY DESIGN/SETTING: ALIF was performed using titanium alloy interbody fusion devices with and without adjunctive DC electrical stimulation in nonhuman primates. METHODS: ALIF was performed through an anterolateral approach in 35 macaques with autogenous bone graft and either a titanium alloy (Ti-6Al-4V) fusion device or femoral allograft ring. The fusion devices of 19 animals received high (current density 19.6 microA/cm2) or low (current density 5.4 microA/cm2) DC electrical stimulation using an implanted generator for a 12- or 26-week evaluation period. Fusion sites were studied using serial radiographs, computed tomography imaging, nondestructive mechanical testing and qualitative and semiquantitative histology. RESULTS: Fusion was achieved with the titanium fusion device and autogenous bone graft. At 12 weeks, the graft was consolidating and early to moderate bridging callus was observed in and around the device. By 26 weeks, the anterior callus formation was more advanced with increased evidence of bridging trabeculations and early bone remodeling. The callus formation was not as advanced or abundant for the allograft ring group. Histology revealed the spinal fusion device had an 86% incidence of bony fusion at 26 weeks compared with a 50% fusion rate for the allograft rings. DC electrical stimulation of the fusion device had a positive effect on anterior interbody fusion by increasing both the presence and extent of bony fusion in a current density-dependent manner. CONCLUSIONS: Adjunctive DC electrical stimulation of the fusion device improved the rate and extent of bony fusion compared with a nonstimulated device. The fusion device was equivalent to or better than the femoral allograft ring in all evaluations. The use of adjunctive direct current electrical stimulation may provide a means of improving anterior interbody fusion.