Article Figures & Data
Figures
- Figure 1
Configuration and modularity of the novel MectaLIF implant. (A) Three-hole design that provides additional flexibility in order to accommodate the iliac artery bifurcation. (B) Flush construct with no anterior profile in order to reduce impact and irritation. (C) Anterior view of the implant showing the sterile-wrapped plate that can be disassembled in one click and replaced with another indication-specific plate. (D) Superior view of the implant demonstrating the large central bone graft area.
- Figure 2
Example of radiographic measurements. (A) Sagittal vertical axis (SVA) measured as the distance from the posterosuperior corner of S1 horizontally to a vertical line dropped from the center of the C7 vertebral body. (B) T4-12 kyphosis measured from the cranial endplate of T4 to the caudal endplate of T12. (C) L1-S1 lordosis measured from the superior endplate of L1 to the superior endplate of S1. (D) L1-4 lordosis measured from the cranial endplate of L1 to the caudal endplate of L4. (E) L4-S1 lordosis measured from the cranial endplate of L4 to the cranial endplate of S1. (F) PI-LL tool using the femoral heads and the cranial endplates of L1 and S1 to calculate pelvic tilt (PT), pelvic incidence (PI), and sacral slope (SS).
- Figure 3
Single patient requiring revision of the implant. (A) Intraoperative radiograph after index anterior procedure showing implant fixation with S1 screws and good opposition of the implant on L5 with a residual spondylolisthesis. (B) After placement of posterior instrumentation and anatomic reduction of L5 on S1, the implant appears to have migrated but is in fact stable in position on S1 with loss of contact with L5. (C) Repeat postoperative radiograph after L5-S1 implant revision with the addition of L5 fixation. Anatomic reduction of L5 on S1 with full implant contact with both vertebrae has been achieved.
- Figure 4
Patient requiring a reoperation with the placement of posterior instrumentation for recurrence of radiculopathy after implant subsidence. (A) Intraoperative radiograph showing good position of L4-5 and L5-S1 implants. (B) Computed tomography scan obtained after recurrence of L4 radiculopathy showing subsidence of L4-5 implant into the superior endplate of L4. (C) Postoperative radiograph showing placement of posterior instrumentation for stabilization. The anterior lumbar interbody fusion implant was not revised.
Tables
Variable All Short Fusion Long Fusion P N (%) 108 68 (63.0) 40 (37.0) N/A Age, y Mean (SD) 59.8 (11.0) 58.1 (11.9) 62.9 (8.5) 0.027 Range 28–81 28–81 38–76 N/A Sex, n (%) Men 51 (47.2) 34 (50.0) 17 (42.5) 0.451a Women 57 (52.8) 34 (50.0) 23 (57.5) Follow-up Days Mean (SD) 623.2 (353.9) 628.3 (366.8) 614.5 (335.2) 0.846 Range 48–1711 48–1711 85–1556 N/A Years Mean (SD) 1.71 (0.97) 1.72 (1.0) 1.68 (0.92) 0.846 Range 0.13–4.69 0.13–4.69 0.23–4.26 N/A Body mass index, kg/m2 Mean (SD) 27.6 (4.87) 27.8 (4.6) 27.2 (5.3) 0.552 Range 17.4–40.0 17.7–40.0 17.5–38.1 N/A Race, n (%) White/Caucasian 92 (85.2) 59 (86.8) 33 (82.5) 0.547a Black/African American 7 (6.5) 4 (5.9) 3 (7.5) 0.708 Native Hawaiian/Pacific Islander 2 (1.9) 0 (0.0) 2 (5.0) 0.135 Other/Asian 2 (1.9) 2 (2.9) 0 (0.0) 0.529 Other 5 (4.6) 3 (4.4) 2 (5.0) >0.99 Ethnicity, n (%) Non-Hispanic/Latino(a) 102 (94.4) 64 (94.1) 37 (92.5) 0.708 Hispanic/Latino(a) 5 (4.6) 4 (5.9) 2 (5.0) >0.99 Other 1 (0.9) 0 (0.0) 1 (2.5) 0.37 Smoking/nicotine, n (%) Current 9 (8.3) 5 (7.4) 4 (10.0) 0.284a Former 52 (48.1) 34 (50.0) 18 (45.0) 0.616a Never 47 (43.5) 29 (42.7) 18 (45.0 0.812a Diabetes, n (%) Yes 11 (10.2) 8 (11.8) 3 (7.5) 0.479 No 97 (89.8) 60 (88.2) 37 (92.5) Osteoporosis, n (%) Yes 16 (12.0) 7 (10.3) 9 (22.5) 0.085 No 92 (88.0) 61 (89.7) 31 (77.5) Abbreviation: N/A, not applicable.
↵a Fisher’s exact test was performed for comparison; all other comparisons of proportions were performed with the χ2 test
Variable All Short Fusion Long Fusion P Preoperative diagnosis, n (%) Degenerative disc disease 104 (96.3) 66 (97.1) 39 (97.5) 0.651a Stenosis 94 (87.0) 61 (89.7) 33 (82.5) 0.282 Spondylolisthesis 38 (35.2) 29 (42.7) 9 (22.5) 0.034 Radiculopathy 92 (85.2) 61 (89.7) 31 (77.5) 0.084 Neurogenic claudication 26 (24.1) 13 (19.1) 13 (32.5) 0.116 Back pain 100 (92.6) 60 (88.2) 40 (100.0) 0.024 Kyphosis 22 (20.4) 6 (8.8) 16 (40.0) <0.001 Scoliosis 41 (38.0) 12 (17.7) 29 (72.5) <0.001 Sagittal imbalance 24 (22.2) 8 (11.8) 16 (40.0) 0.001 Pseudarthrosis 8 (7.4) 7 (10.3) 1 (2.5) 0.135 Infection 1 (0.9) 0 (0.00) 1 (2.5) 0.37a Fracture 1 (0.9) 1 (0.9) 0 (0.0) 1.0 Novel implant device data Total number in cohort 278 164 114 No. per patient, n (%) 1-level 2 (1.9) 1 (1.5) 1 (2.5) >0.99a 2-level 50 (46.3) 42 (61.8) 8 (20.0) <0.001 3-level 48 (44.4) 21 (30.9) 27 (67.5) <0.001 4-level 8 (7.4) 4 (5.9) 4 (10.0) 0.465a Mean/patient (SD) 2.57 (0.66) 2.41 (0.63) 2.85 (0.62) <0.001 Range 1–4 1–4 1–4 N/A Levels, n (%) L2–L3 8 (7.4) 5 (7.4) 3 (7.5) 0.978 L3–L4 59 (54.6) 28 (41.2) 31 (77.5) <0.001 L4–L5 105 (97.2) 65 (95.6) 40 (100) 0.294a L5–S1 104 (95.4) 65 (95.6) 39 (97.5) >0.99a L5–L6/L6–S1 2 (1.9) 1 (1.5) 1 (2.5) >0.99a Posterior fusion, n (%) Yes 101 (93.5) 61 (89.7) 40 (100.0) 0.036 No 7 (6.5) 7 (10.3) 0 (0.0) 0.045a No. of levels Mean (SD) 5.1 (4.0) 2.4 (1.1) 9.7 (2.7) <0.001 Range 0–15 0–5 8–15 N/A Estimated blood loss, mL Mean (SD) 858.9 (1027.1) 432.1 (535.3) 1573.8 (1243.1) <0.001 Range 50–6150 50–3050 250–6150 N/A Length of stay, d Mean (SD) 6.2 (3.6) 4.9 (2.5) 8.5 (4.0) <0.001 Range 1–20 1–13 4–20 N/A Abbreviation: N/A, not applicable.
↵a Fisher’s exact test was performed for comparison; all other comparisons of proportions were performed with the χ2 test.
Medical Outcome, n (%) All Short Fusion Long Fusion P Acute blood loss anemia 84 (77.8) 46 (67.6) 38 (95.0) 0.001 Urinary retention 11 (10.2) 6 (8.8) 5 (12.5) 0.542 Urinary tract infection/urosepsis 11 (10.2) 4 (5.9) 7 (17.5) 0.054 Acute kidney injury 6 (5.6) 3 (4.4) 3 (7.5) 0.668a Altered mental status 8 (7.4) 6 (8.8) 2 (5.0) 0.522 Hypotension 11 (10.2) 4 (5.9) 7 (17.5) 0.054 Cardiac arrhythmia 7 (6.5) 2 (2.9) 5 (20.0) 0.051 Ileus 19 (17.6) 6 (8.8) 13 (32.5) <0.001 Clostridioides difficile 2 (1.9) 2 (2.9) 0 (0.0) 0.53a Respiratory complication 18 (16.7) 3 (4.4) 15 (37.5) <0.001 Deep vein thrombosis/pulmonary embolism 3 (2.8) 1 (1.5) 2 (5.0) 0.554a ↵a Fisher’s exact test was performed for comparison; all other comparisons of proportions were performed with the χ2 test.
Surgical Outcome, n (%) All Short Fusion Long Fusion P Iliac vein injury 3 (2.8) 2 (2.9) 1 (2.5) 1.0a Dural tear 5 (4.6) 1 (1.5) 4 (10.0) 0.062a Posterior implant problem 2 (1.9) 2 (2.9) 0 (0.0) 0.53a Estimated blood loss >2500 mL 8 (7.4) 1 (1.5) 7 (17.5) 0.004a Neurological injury 1 (0.9) 1 (1.5) 0 (0.0) 1.0a Bone morphogenetic protein neuritis 4 (3.7) 4 (5.9) 0 (0.0) 0.294a Wound complications 13 (12.0) 4 (5.9) 9 (22.5) 0.015a Wound infection 5 (4.6) 1 (1.5) 4 (10.0) 0.01 Symptomatic hardware 6 (5.6) 3 (4.4) 3 (7.5) 0.668a Abdominal hernia 3 (2.8) 2 (2.9) 1 (2.5) 1.0a Sacroiliac joint dysfunction 2 (1.9) 2 (2.9) 0 (0.0) 0.53a Persistent radiculopathy 1 (0.9) 1 (1.5) 0 (0.0) 1.0a PJK/PJF/PJ 8 (7.4) 2 (2.9) 6 (15.0) 0.05a Adjacent segment degeneration 21 (19.4) 14 (20.6) 7 (17.5) 0.022 Rod fracture 3 (2.8) 0 (0.0) 3 (2.8) 0.07 Abbreviation: PJK/PJF/PJ, proximal junctional kyphosis/proximal junctional failure/proximal junctional fracture.
↵a Fisher’s exact test was performed for comparison; all other comparisons of proportions were performed with the χ2 test.
Complications, n (%) All Short Fusion Long Fusion P Subsidence Patients 5 (4.6) 4 (5.9) 1 (2.5) 0.649a All implants 5 (1.8) 4 (2.4) 1 (0.9) 0.649a Migration Patients 1 (0.9) 1 (1.5) 0 (0.0) >0.99a All implants 1 (0.4) 1 (0.6) 0 (0.0) >0.99a Nonunion Patients 6 (5.6) 2 (2.9) 4 (10.0) 0.191a All implants 6 (2.2) 2 (1.2) 4 (3.5) 0.191a Surgical revision Patients 1 (0.9) 1 (1.5) 0 (0.0) >0.99a All implants 1 (0.4) 1 (0.6) 0 (0.0) >0.99a ↵a Fisher’s exact test was performed for comparison; all other comparisons of proportions were performed with the χ2 test.
Outcome Measure All Short Fusion Long Fusion P Readmission, n (%) Yes 36 (33.3) 19 (27.9) 17 (42.5) 0.12 No 72 (66.7) 49 (72.1) 23 (57.5) Time to readmission Days Mean (SD) 600.1 (531.4) 683.6 (651.3) 406.1 (316.2) 0.12 Range 2–1755 2–1755 9–1029 N/A Years Mean (SD) 1.64 (1.46) 1.87 (1.78) 1.11 (0.87) 0.12 Range 0.01–4.81 0.01–4.81 0.02–2.82 N/A Reoperation, n (%) Yes 33 (30.6) 18 (26.5) 15 (37.5) 0.23 No 75 (69.4) 50 (73.5) 25 (62.5) Time to reoperation Days Mean (SD) 570.9 (532.1) 665.6 (661.1) 457.3 (301.7) 0.162 Range 2–1755 2–1755 51–1029 N/A Years Mean (SD) 1.56 (1.46) 1.82 (1.81) 1.25 (0.83) 0.162 Range 0.01–4.81 0.01–4.81 0.14–2.82 N/A Reason for Reoperation, n (%), % of all reoperations Adjacent segment degeneration 9 (8.3), 27.3 7 (10.3), 38.9 2 (5.0), 13.3 0.48 Proximal junctional kyphosis/proximal junctional failure/proximal junctional fracture 4 (3.78), 12.1 0 (0.0), 0.0 4 (10.0), 26.7 0.017 Painful iliac bolts 5 (4.6), 15.2 3 (4.4), 16.7 2 (5.0), 13.3 1.0 Wound complication 6 (5.6), 18.2 2 (2.9), 11.1 4 (10.0), 26.7 0.191 Acute implant problem 3 (2.8), 9.1 3 (4.4), 16.7 0 (0.0), 0.0 0.294 Fracture/spinopelvic dissociation 2 (1.9), 6.1 0 (0.0), 0.0 2 (5.0), 13.3 0.135 Recurrent stenosis/radiculopathy 4 (3.7), 12.1 3 (4.4), 16.7 1 (2.5), 6.7 1.0 Nonunion/rod failure 2 (1.9), 6.1 0 (0.0), 0.0 2 (5.0), 13.3 0.135 Sacroiliac joint dysfunction 2 (1.9), 6.1 2 (2.9), 11.1 0 (0.0), 0.0 0.529 Device migration 1 (0.9), 3.0 1 (1.5), 5.6 0 (0.0), 0.0 1.0 Device subsidence 1 (0.9), 3.0 1 (1.5), 5.6 0 (0.0), 0.0 1.0 Abbreviation: N/A, not applicable.
Variable N Mean (SD) P Preoperative Postoperative Preoperative to Postoperative LL (°) L1–S1 107 44.4 (16.2) 55.1 (12.8) 10.7 (14.5) <0.001 L1–L4 107 19.7 (12.0) 21.4 (10.8) 1.8 (10.8) 0.1 L4–S1 106 30.9 (10.3) 38.4 (8.7) 7.5 (8.2) <0.001 T4–T12 Thoracic kyphosis (°) 42 31.7 (14.7) 45.4 (12.4) 13.6 (12.5) <0.001 Spinopelvic parameters (°) Sacral slope 103 33.0 (11.0) 37.6 (10.9) −4.7 (6.9) <0.001 Pelvic tilt 103 19.6 (9.5) 18.2 (9.1) 1.4 (5.7) 0.02 PI 103 52.5 (12.3) 55.8 (12.9) −3.3 (6.3) <0.001 PI-LL 102 8.9 (15.1) 1.1 (13.5) 7.8 (14.2) <0.001 Sagittal vertical axis, mm 44 48.2 (56.8) 24.5 (55.3) 23.8 (53.4) 0.005 Abbreviations: LL, lumbar lordosis; PI, pelvic incidence.
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