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Research ArticleLumbar Spine

Efficacy of Stand-Alone Anterior Lumbar Interbody Fusion With PEEK Cages, BMP-2, and Allografts for Treating Discogenic Low Back Pain: Assessing Clinical and Radiographic Outcomes

Matthew Scott-Young, David Nielsen, Evelyne Rathbone, Sukhman Riar and Miller Gantt
International Journal of Spine Surgery October 2024, 18 (5) 502-513; DOI: https://doi.org/10.14444/8679
Matthew Scott-Young
1 Faculty of Health Science and Medicine, Bond University, Gold Coast, Queensland, Australia
2 Gold Coast Spine, Gold Coast, Queensland, Australia
MBBS, FRACS, FAOʀᴛʜA
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  • For correspondence: swalter@goldcoastspine.com.au
David Nielsen
2 Gold Coast Spine, Gold Coast, Queensland, Australia
MBBS, FRACS, FAOʀᴛʜA
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Evelyne Rathbone
1 Faculty of Health Science and Medicine, Bond University, Gold Coast, Queensland, Australia
MSᴄ, Csᴛᴀᴛ
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Sukhman Riar
1 Faculty of Health Science and Medicine, Bond University, Gold Coast, Queensland, Australia
2 Gold Coast Spine, Gold Coast, Queensland, Australia
BBɪᴏᴍᴇᴅ Sᴄ
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Miller Gantt
3 School of Medicine, Mercer University, Macon, Georgia, USA
BSᴄɪ
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  • Figure 1
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    Figure 1

    Dynamic x-ray images showing stability across the anterior lumbar interbody fusion construct in flexion (A) and extension (B). Fine-cut computed tomography images showing confluent bridging bone assessed on sagittal (C) and coronal (D) sequences.

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    Figure 2

    Preparation of anterior lumbar interbody fusion surgical constructs. (A) Hole drilled through femoral head allograft and recombinant human bone morphogenetic protein-2 (rhBMP-2) sponge packed inside. (B) The allograft wrapped in rhBMP-2 sponge. (C) Construct press-fitted inside the polyetheretherketone cage. (D) Cage, allograft, and rhBMP-2.

  • Figure 3
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    Figure 3

    Fusion rates at 6 and 12 months by age, review, cage, and anterior lumbar interbody fusion (ALIF) groups. (A) *Lower fusion rate of (n = 1 of 4) 75% at 12 months for the >65 groups compared with other groups: <40 (P < 0.001) and 40–65 (P = 0.014). (B) No significant difference was detected between reviews. (C) *Higher fusion rates (CT + XR) were obtained with STALIF (99.7%) and Australis (99.6%) cages at 6 months than with Brantigan (97.7%). There is no significant difference in overall fusion rates between cage types. (D) *At 12 months, all patients in the Lower ALIF group achieved fusion compared with (n = 1 of 6) 83.3% in the higher group (P < 0.001). CT, computed tomography; PACS, picture archiving and communication system; XR, x-ray imaging.

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    Figure 4

    Fusion rates in spine surgery patients (n = 1335) were higher than 95% in all available cases, except for the L3–L4/L4–L5/L5–S1 anterior lumbar interbody fusion (ALIF) combination at 12 months, where two-thirds of the group achieved fusion (n = 1 of 3, 66.7%). However, it is noteworthy that all 11 cases with the same combination achieved fusion at 6 months. There were 2 cases of pseudoarthrosis at single levels (L4–L5 and L5–S1) at 6 months (the latter is hard to detect on the graph due to the high percentage of patients achieving fusion). The third case occurred at 12 months in a 3-level ALIF.

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    Figure 5

    Median differences from baseline and 95% confidence interval for visual analog scale (VAS) back and leg pain scores over 12 months after surgery. All median change scores were above the minimal clinically important difference (MCID), and most median scores were above the substantial clinical benefit (SCB).

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    Figure 6

    Mean differences from baseline and 95% confidence interval for Oswestry Disability Index (ODI) and Roland-Morris Disability Questionnaire (RMDQ) disability scores over 12 months after surgery. All mean change scores were above the minimal clinically important difference (MCID) for both measures and above the substantial clinical benefit (SCB) for ODI. No SCB reference was available for RMDQ.

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    Figure 7

    Patient satisfaction levels within 12 months after surgery rated as poor (1), satisfactory (2), good (3), or excellent (4).

Tables

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    Table 1

    Demographic characteristics of study participants.

    Characteristic n (%)
    Age at time of surgery, y, mean (SD)48.5 (11.4)
    Age group
     <40 y303 (22.7)
     40–65 y946 (70.9)
     >65 y86 (6.4)
    Review type
     Chart (2005–2008)263 (19.7)
     PACS image (2009–2019)1072 (80.3)
    Cage type
     Brantigan (2005–2009)374 (28.0)
     STALIF (2010–2013)381 (28.5)
     Australis (2014–2019)580 (43.4)
    ALIF level1614 (100.0)
     L2–L33 (0.2)
     L3–L452 (3.9)
     L4–L5279 (20.9)
     L5–S11273 (95.4)
     S1–S27 (0.5)
    ALIF group
     Higher (cases with L2–L3 and L3–L4)54 (4.0)
     Lower (cases with L4–L5 and lower)1281 (96.0)
    Single level1072 (80.3)
     L2–L31 (0.1)
     L3–L44 (0.3)
     L4–L546 (3.4)
     L5–S11018 (76.3)
     S1–S23 (0.2)
    2-Level247 (18.5)
     L3–L4/L4–L57 (0.5)
     L3–L4/L5–S126 (1.9)
     L4–L5/L5–S1210 (15.7)
     L5–S1/S1–S24 (0.3)
    3-Level16 (1.2)
     L2–L3/L3–L4/L4–L51 (0.1)
     L2–L3/L4–L5/L5–S11 (0.1)
     L3–L4/L4–L5/L5–S114 (1.0)
    • Abbreviations: ALIF, anterior lumbar interbody fusion; PACS, picture archiving and communication system.

    • Note: Data presented as n (%) unless otherwise noted.

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    Table 2

    Fusion rates for 1335 surgery patients.

    FusionOverall
    (n = 1335)
    Months After Surgery
    6
    (n = 1235)
    12
    (n = 90)
    >12
    (n = 7)
    NA
    (n = 3)
    Fused (CT + XR)1313 (98.4)1225 (91.8)83 (6.2)5 (0.4)-
    Fused (XR)16 (1.2)8 (0.6)6 (0.4)2 (0.1)-
    Pseudoarthrosis3 (0.2)2 (0.1)1 (0.1)--
    Unavailable3 (0.2)---3 (0.2)
    • Abbreviations: CT, computed tomography; NA, not applicable; XR, x-ray imaging.

    • Note: Data are presented as n (%). Percentages for cells under “months after surgery” are calculated from the total sample size.

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    Table 3

    VAS back and leg pain outcomes over 12 months in 1335 surgery patients.

    Months PostsurgeryVAS OutcomeChange From Baseline
    n MedianIQR n Median Differencea 95% CI P b
    Back Pain
     0 (baseline)105872.056.3–83.0
     3127417.05.3–38.0101946.045.0–50.0<0.001
     6122711.03.0–26.097554.052.0–57.0<0.001
     1211209.02.0–23.091556.053.0–58.0<0.001
    Leg Pain
     0 (baseline)104943.09.0–72.0
     312749.00.0–30.0101018.015.0–23.0<0.001
     612252.00.0–15.096526.022.0–30.0<0.001
     1211162.00.0–13.090028.023.0–33.0<0.001
    • Abbreviations: IQR, interquartile range; VAS, visual analog scale (0 = no pain to 100 = worst pain).

    • ↵a A positive median difference indicates an improvement or reduction in pain score.

    • ↵b All differences from baseline were statistically significant.

    • View popup
    Table 4

    ODI and RMDQ disability outcomes over 12 months in 1335 surgery patients.

    Months PostsurgeryDisability OutcomeChange From Baseline
    n MedianIQR n Mean
    Differencea
    95% CI P b
    ODI
     0 (baseline)105842.032.0–53.0
     3126218.08.0–29.8101123.422.2–24.5<0.001
     6122210.02.0–20.097229.828.8–30.9<0.001
     1211158.00.0–20.091030.929.8–32.1<0.001
    RMDQ
     0 (baseline)105916.012.0–19.0
     312665.02.0–9.010129.28.8–9.7<0.001
     612212.00.0–5.097011.611.2–12.0<0.001
     1211151.00.0–4.090812.211.8–12.6<0.001
    • Abbreviations: IQR, interquartile range; ODI, Oswestry Disability Index (0 = no disability to 100 = worst disability); RMDQ, Roland-Morris Disability Questionnaire (0 = no disability to 24 = worst disability).

    • ↵a A positive mean difference indicates an improvement or reduction in disability score.

    • ↵b All differences from baseline were statistically significant.

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    Table 5

    Results of the between-groups post-hoc comparisons of the change in pain outcomes after controlling for baseline scores in a multivariable mixed-effects regression model.

    ComparisonEstimated Differencea 95% CI P
    LowerUpper
    Change in VAS back painb
     3 mo6 mo5.303.926.68<0.001c
     6 mo12 mo1.470.042.900.13
     3 mo12 mo6.775.368.18<0.001c
     <40 y40–65 y2.37−0.305.040.25
     40–65 y>65 y1.45−3.025.92>0.99
     <40 y>65 y0.92−3.975.80>0.99
     BrantiganSTALIF2.51−0.195.200.21
     STALIFAustralis3.010.255.770.10
     BrantiganAustralis5.512.848.19<0.001c
     Higher ALIFLower ALIF7.491.8313.140.010c
    Change in VAS leg paina
     3 mo6 mo7.866.319.41<0.001c
     6 mo12 mo0.64−0.972.25>0.99
     3 mo12 mo8.506.9110.09<0.001c
     <40 y40–65 y4.361.926.800.001c
     40–65 y>65 y6.602.3310.870.007c
     <40 y>65 y10.966.3415.58<0.001c
     BrantiganSTALIF2.26−0.274.790.24
     STALIFAustralis1.89−0.664.440.44
     BrantiganAustralis4.151.636.680.004c
     Higher ALIFLower ALIF0.49−4.725.700.85
    • Abbreviations: ALIF, anterior lumbar interbody fusion; VAS, visual analog scale.

    • ↵a The estimated difference is the more significant improvement experienced by the category in bold text for each pairwise comparison. None of the estimated differences between groups were clinically significant.

    • ↵b The estimated mean improvement at 3 months postsurgery for a <40-year-old patient with mean baseline, Brantigan cage, and higher ALIF were 44.7 for back pain and 26.6 for leg pain.

    • ↵c Statistically significant difference P < 0.05.

    • View popup
    Table 6

    Results of the between-groups post-hoc comparisons of the change in disability outcomes after controlling for baseline scores in a multivariable mixed-effects regression model.

    ComparisonEstimated Differencea 95% CI P
    LowerUpper
    Change in ODIb
     3 mo6 mo6.465.727.21<0.001c
     6 mo12 mo0.900.121.670.07
     3 mo12 mo7.366.608.12<0.001c
     <40 y40–65 y2.881.124.630.004c
     40–65 y>65 y0.37−2.553.29>0.99
     <40 y>65 y3.250.056.440.14
     BrantiganSTALIF0.11−1.671.88>0.99
     STALIFAustralis1.860.043.680.14
     BrantiganAustralis1.970.223.720.08
     Higher ALIFLower ALIF5.742.019.460.003c
    Change in RMDQa
     3 mo6 mo2.372.102.64<0.001c
     6 mo12 mo0.490.210.770.002c
     3 mo12 mo2.862.583.14<0.001c
     <40 y40–65 y0.800.191.420.030c
     40–65 y>65 y0.42−0.601.44>0.99
     <40 y>65 y1.220.112.340.10
     BrantiganSTALIF0.15−0.470.77>0.99
     STALIFAustralis0.930.291.560.013c
     BrantiganAustralis1.080.471.690.002c
     Higher ALIFLower ALIF2.611.323.91<0.001c
    • Abbreviations: ALIF, anterior lumbar interbody fusion; ODI, Oswestry Disability Index; RMDQ, Roland-Morris Disability Questionnaire.

    • ↵a The estimated difference is the more significant improvement experienced by the category in bold text for each pairwise comparison. None of the estimated differences between groups were clinically significant.

    • ↵b The estimated mean improvement at 3 months postsurgery for a <40-year-old patient with mean baseline, Brantigan cage, and higher ALIF were 25.5 for ODI and 9.8 for RMDQ.

    • ↵c Statistically significant difference P < 0.05.

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Efficacy of Stand-Alone Anterior Lumbar Interbody Fusion With PEEK Cages, BMP-2, and Allografts for Treating Discogenic Low Back Pain: Assessing Clinical and Radiographic Outcomes
Matthew Scott-Young, David Nielsen, Evelyne Rathbone, Sukhman Riar, Miller Gantt
International Journal of Spine Surgery Oct 2024, 18 (5) 502-513; DOI: 10.14444/8679

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Efficacy of Stand-Alone Anterior Lumbar Interbody Fusion With PEEK Cages, BMP-2, and Allografts for Treating Discogenic Low Back Pain: Assessing Clinical and Radiographic Outcomes
Matthew Scott-Young, David Nielsen, Evelyne Rathbone, Sukhman Riar, Miller Gantt
International Journal of Spine Surgery Oct 2024, 18 (5) 502-513; DOI: 10.14444/8679
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Keywords

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  • spinal fusion
  • rhBMP-2
  • degenerative disc disease

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