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Research ArticleArticles

Preliminary Results of Bioactive Amniotic Suspension with Allograft for Achieving One and Two-Level Lumbar Interbody Fusion

Pierce D. Nunley, Eubulus J. Kerr, Philip A. Utter, David A. Cavanaugh, Kelly A. Frank, Devan Moody, Brian McManus and Marcus B. Stone
International Journal of Spine Surgery January 2016, 10 12; DOI: https://doi.org/10.14444/3012
Pierce D. Nunley
Spine Institute of Louisiana, Shreveport, Louisiana, USA
MD
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Eubulus J. Kerr III
Spine Institute of Louisiana, Shreveport, Louisiana, USA
MD
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Philip A. Utter
Spine Institute of Louisiana, Shreveport, Louisiana, USA
MD
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David A. Cavanaugh
Spine Institute of Louisiana, Shreveport, Louisiana, USA
MD
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Kelly A. Frank
Spine Institute of Louisiana, Shreveport, Louisiana, USA
MS
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Devan Moody
Spine Institute of Louisiana, Shreveport, Louisiana, USA
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Brian McManus
Spine Institute of Louisiana, Shreveport, Louisiana, USA
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Marcus B. Stone
Spine Institute of Louisiana, Shreveport, Louisiana, USA
PhD
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Article Figures & Data

Figures

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  • Fig. 1
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    Fig. 1

    CT Classification of Spinal Fusion. 0 – No bony ingrowth; 1 – Cranial downgrowth or caudal upgrowth; 2 – Cranial downgrowth and caudal upgrowth but NOT bridging; 3 – Complete bridging trabecular bone fusion; A – No evidence of supplemental fixation failure/no halo seen; B – Evidence of supplemental fixation failure/halo seen.

  • Fig. 2
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    Fig. 2

    Representative example of 2A fusion status

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    Fig. 3

    Representative example of 3A fusion status.

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    Fig. 4

    One-level fusion status.

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    Fig. 5

    Two-level fusion status by patient.

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    Fig. 6

    Two-level fusion status by level.

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    Fig. 7

    One-Level Clinical Outcomes preoperative and postoperative. Error Bars show standard deviation from the mean.

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    Fig. 8

    Two-Level Clinical Outcomes preoperative and postoperative. Error Bars show standard deviation from the mean.

Tables

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    Table 1

    Patient Demographics.

    DemographicOne-LevelTwo-Level
    N (No.)3834
    Age (Mean ± SD)58.4 ±12.749.3±10.9
    BMI (Mean ± SD)30.6±6.0830.1±5.82
    Male (%)11 (28.9)14 (41.2)
    Female (%)27 (71.1)20 (58.8)
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    Table 2

    Levels treated in one-level patients.

    One-Level
    Levels TreatedNo. Patients
    L1-L21
    L2-L31
    L3-L46
    L4-L520
    L5-S110
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    Table 3

    Levels treated in two-level patients.

    Two-Level
    Levels TreatedNo. Patients
    L2-L41
    L3-L59
    L4-S124
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    Table 4

    Fusion Status by Surgical Approach.

    CT Fusion Status
    Approach12A3ATotal Levels
    ALIF0115364
    LLIF072330
    TLIF12912
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    Table 5

    One and two-level patient comorbidities.

    No. of ComorbiditiesComorbiditiesOne-LevelTwo-Level
    NoneN/A4 (10.5%)4 (11.8%)
    Total of Patients with No Comorbidities 4 (10.5%) 4 (11.8%)
    OneOverweight3 (7.9%)6 (17.6%)
    Obese4 (10.5%)11 (32.4%)
    PLS2 (5.3%)0 (0.0%)
    Smoking0 (0.0%)3 (8.8%)
    Total of Patients with One-Comorbidity 9 (23.7%) 20 (58.8%)
    TwoSmoking / PLS1 (2.6%)0 (0.0%)
    Overweight / PLS5 (13.2%)1 (2.9%)
    Overweight / Smoking1 (2.6%)2 (5.9%)
    Overweight / Diabetes1 (2.6%)1 (2.9%)
    Obese / Smoking5 (13.2%)2 (5.9%)
    Obese / Diabetes3 (7.9%)2 (5.9%)
    Total of Patients with Two-Comorbidities 16 (42.1%) 8 (23.5%)
    ThreeOverweight / Smoking / PLS1 (2.6%)0 (0.0%)
    Overweight / Diabetes / PLS1 (2.6%)0 (0.0%)
    Obese / Smoking / Diabetes1 (2.6%)0 (0.0%)
    Obese / Diabetes / PLS4 (10.5%)1 (2.9%)
    Obese / Smoking / PLS2 (5.3%)1 (2.9%)
    Total of Patients with Three Comorbidities 9 (23.7%) 2 (5.9%)
    • View popup
    Table 6

    Published Fusion Rates for Bone Grafts.

    AuthorEvaluation of FusionGraft MaterialComorbiditiesTimeFusion Rate
    Dimar et al. (2006)32 CT: Solid Unilateral or bilateral fusionrhBMP-2/CRMWorkers comp – 13.2%
    Spinal litigation- 3.8%
    Smoking- 32.1%
    12 months90.6%
    ICBGWorkers comp -17.8%
    Spinal litigation -15.6%
    Smoking - 22.2%
    12 months73.3%
    Jenis and Banco (2010)37 CT: Graft consolidation on a least 2 contiguous cuts and in at least 2 of 3 planesSilicate-substituted calcium phosphate (Actifuse, Baxter)Smoking-9.5%
    Diabetics- 9.5%
    12 months76.2%
    Nagineni etal. (2012)36 CT: Graft consolidation on a least 2 contiguous cuts and in at least 2 of 3 planesSilicate-substituted calcium phosphate (Actifuse, Baxter)Smoking – 11%∼12 months80% (Lumbaronly)
    Nandyala etal. (2014)38 CT: Presence of bridging trabecular bone on at least 2 consecutive coronal and sagittal images, blurring of the bone-graft endplate junction, and absence of radiologic cleft within fusion massA Silicate-substituted calcium phosphate (Actifuse, Baxter)Workers comp –38.5%
    Smoking – 30.8%
    12 months65.4%
    rhBMP-2 (INFUSE, Medtronic, Inc.)Workers comp –26.9%
    Smoking – 26.9%
    12 months92.3%
    Roh et al. (2013)39 Radiograph: Presence of bridging bone across endplates or from endplates to interspace disc plugsrhBMP-2 (INFUSE, Medtronic, Inc.)Not available12 months83.5%
    Allogenic Morphogenic protein (OsteoAMP, Advanced Biologics)Not available12 months93.3%
    Park et al (2013)33CT: Presence of bridging trabecular bone on at least 2 images and cortication of the peripheral edges of the fusion massrhBMP-2 (INFUSE, Medtronic) with LBGNot available12 months85.7%
    rhBMP-2 (INFUSE, Medtronic) with ICBGNot available12 months83.4%
    Malham, etal. (2014)26 CT: Presence of bridging trabecular bonerhBMP-2 (INFUSE, Medtronic, Inc.)Smoking-9.2%
    Diabetes-2.3%
    Hypertension-7.6%
    Depression-3.8%
    Prior lumbar surgery-14.5%
    12 months96.5% ALIF
    97.8 Hybrid
    Ammerman,et al. (2013)17 If patient asymptomatic: Radiographic evidence of bridging bone with no motion – 100% of patients evaluated with radiograph
    or
    If patient symptomatic: CT evidence of bridging bone
    Allograft cellular bone matrix containing mesenchymal stem cells (MSCs) and osteoprogenitor cells combined with DBM and cancellous bone (Osteocel Plus, Nuvasive)Osteoporosis - 4.3%
    Diabetes - 13.0%
    Smoking - 4.3%
    Chronic steroid use -4.3%
    12 months92.3%
    Tohmeh et al. (2012)40 Fluoroscopy-guided radiography (FGX)- 98% of patients evaluated with FGX
    or
    CT: Complete ossification with some component of endplate involvement. – One patient (3%) was evaluated with CT
    Allograft cellular bone matrix containing mesenchymal stem cells (MSCs) and osteoprogenitor cells combined with DBM and cancellous bone (Osteocel Plus, Nuvasive)Tobacco use - 12.5%
    Coronary ArteryDisease - 47.5%
    Diabetes - 20%
    COPD - 5%
    Steroid use - 8% Any prior spinesurgery - 65% Any prior spinesurgery - 65%
    12 months90.20%
    Sardar, etal. (2015)19 Based on Medical Metrics Inc. (Houston, Texas) criteria using CT and radiographs:
    Evidence of bridging bone
    Less than 50% radiolucency
    Less than 5 degrees of motion and less than 3 mm translation
    B2A peptide (Prefix 150, BioSET, Inc)Not available12 months50%
    B2A peptide (Prefix 750, BioSET, Inc)Not available12 months100%
    ICBGNot available12 months77.80%
    Lauweryns,et al. (2015)34 CT: Presence of bridging trabecular boneABM/P-15 (i-FACTOR, Cerpedics, Inc.)*BMI 25-30 - 40%
    BMI >30 - 20%
    Tobacco use - 27.5%
    Diabetes - 12.5%
    12 months97.78%
    ABG12 months82.22%
    Thaler et al. (2013)41 Radiograph: Bony bridging, bony continuity between endplate, trabecular structure in anterior bone and lack of radiolucent lines
    CT: 30% of endplate to endplate bridging anteriorly. Continuous intersegmental bridging in posterior column.
    β – TCP (Chronos, Synthes)Smoking – 32.4% Previous lumbar surgery adjacent to index level – 23.5%12 monthsRadiographic– 47.7%
    CT – 61.4%
    Berjano,etal. (2015)35 CT: Evidence of bridging trabecular bone from lower endplate to upper endplateSynthetic bone graft comprised of calcium phosphate granules and hydroxyapatite (Attrax,Nuvasive)Not available12 months83%
    Nanocrystals -nanohydroxyapatite-based bone graft substitute (Nanostim, Medtronic)Not available12 months100%
    ABGNot available12 months75%
    Calcium triphosphateNot available12 months89%
    Kurd et al. (2014)18CT: Brantigan, Steffee, Fraser method42
    Radiographs: < 5 degrees motion
    Osteconductive - allografts, tri-calcium phosphate (Vitoss, Orthovita, Inc), silicate-substitutedcalcium phosphate (Actifuse, ApaTech), ceramics (Mastergraft, Medtronic), andhydroxyapatite products (nannOss, Pioneer)BMI (mean, SD) -32.5, 7.1
    Smoking - 39.2%
    12 months93.75%
    Osteoinductive - rhBMP-2 (Infuse Kit, Medtronic), demineralized bone matrices (GraftonDBM Matrix, Medtronic, Progenix DBM Putty, Medtronic), and stem cell-based products (Osteocel Plus, Nuvasive Inc)BMI (mean, SD): 30.6,6.4
    Smoking (%): 36.1%
    12 months87.18%
    • ↵* Not available for sale in the USA.

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1 Jan 2016
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Preliminary Results of Bioactive Amniotic Suspension with Allograft for Achieving One and Two-Level Lumbar Interbody Fusion
Pierce D. Nunley, Eubulus J. Kerr, Philip A. Utter, David A. Cavanaugh, Kelly A. Frank, Devan Moody, Brian McManus, Marcus B. Stone
International Journal of Spine Surgery Jan 2016, 10 12; DOI: 10.14444/3012

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Preliminary Results of Bioactive Amniotic Suspension with Allograft for Achieving One and Two-Level Lumbar Interbody Fusion
Pierce D. Nunley, Eubulus J. Kerr, Philip A. Utter, David A. Cavanaugh, Kelly A. Frank, Devan Moody, Brian McManus, Marcus B. Stone
International Journal of Spine Surgery Jan 2016, 10 12; DOI: 10.14444/3012
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Keywords

  • lumbar fusion
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  • allograft
  • bone graft alternative
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