Article Figures & Data
Figures
- Fig. 1
Axial presacral interbody fusion procedure. Guide pin in presacral space docked on the sacrum (A). Dilator and guide pin advanced into the L5-S1 interspace (B). Nitinol cutters debulking disc material and preparing the endplates for fusion (C). It should be noted that the arc of the cutter can be rotated 360° (inset). Finally, the rod is implanted, distracting the interspace and providing L5-S1 stabilization with placement of bone graft (D).
- Fig. 2
AxiaLIF rod device with differential thread pitch to provide interspace distraction during implantation (A). Radiographic image of rod implanted properly in L5-S1 disc space (B).
- Fig. 3
Complication rates with AxiaLIF System, open lumbar fusion, and minimally invasive lumbar fusion. Complication rates with open lumbar fusion were calculated by pooling outcomes from 6 Food and Drug Administration– regulated trials (n = 1,970) using open lumbar fusion for degenerative disc disease as a control.8–13 Complication rates with minimally invasive lumbar fusion were calculated by pooling outcomes from 4 selected clinical trials (n = 122).14–17 Values represent mean ± 95% confidence interval.
Tables
Complication All patients (N = 9,152) Single level (n = 8,034) Two level (n = 1,118) P value* No. of complications 123 103 20 Patients with ≥ 1 complication 120 (1.3%) 102 (1.3%) 18 (1.6%) .43 Bowel injury 59 (0.6%) 50 (0.6%) 9 (0.8%) .61 Hypotension 20 (0.2%) 18 (0.2%) 2 (0.2%) .96 Presacral hematoma 9 (0.1%) 7 (0.1%) 2 (0.2%) .68 Sacral fracture 7 (0.1%) 5 (0.1%) 2 (0.2%) .46 Vascular injury 6 (0.1%) 5 (0.1%) 1 (0.1%) .77 Systemic infection 6 (0.1%) 6 (0.1%) 0 (—) .77 Migration 5 (0.1%) 4 (0.1%) 1 (0.1%) .60 Subsidence 4 (< 0.1%) 3 ( 0.1%) 1 (0.1%) .99 Nerve injury 3 (< 0.1%) 2 ( 0.1%) 1 (0.1%) .81 Superficial wound infection 3 (< 0.1%) 2 ( 0.1%) 1 (0.1%) .81 Ureter injury 1 (< 0.1%) 1 ( 0.1%) 0 (—) .25 ↵* Single level versus 2 level.
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