title: Preliminary Results of Bioactive Amniotic Suspension with Allograft for Achieving One and Two-Level Lumbar Interbody Fusion.
abstract: BACKGROUND
  Bone graft material for lumbar fusion was historically autologous bone graft (ABG). In recent years alternatives such as allograft, demineralized bone matrix (DBM), ceramics, and bone morphogenetic protein (BMP) have gained favor, although the complications of these are not fully understood. Bioactive amniotic suspension (BAS) with allograft is a new class of material derived from human amniotic tissue.
  
  
  METHODS
  Eligible patients receiving a one or two level lumbar interbody fusion with Nucel, a BAS with allograft, were contacted and scheduled for a mininmim 12 month follow-up visit. Patients were evaluated for fusion using CT's and plain radiographs. Clincal outcomes, including ODI, VAS back and leg were collected, as well as comorbidities including BMI, smoking status, diabetes and previous lumbar surgery.
  
  
  RESULTS
  One-level patients (N=38) were 71.1% female with mean age of 58.4 ± 12.7 and mean BMI of 30.6 ± 6.08. Two-level patients (N=34) were 58.8% female with mean age of 49.3 ±10.9 and mean BMI of 30.1 ± 5.82. Kinematic fusion was achieved in 97.4% of one-level patients and 100% of two-level patients. Baseline comorbidities were present in 89.5% of one-level patients and 88.2% of two-level patients. No adverse events related to BAS were reported in this study.
  
  
  CONCLUSIONS
  Fusion status is evaluated with many different biologics and varying methods in the literature. BAS with allograft in this study demonstrated high fusion rates with no complications within a largely comorbid population. Although a small population, BAS with allograft results were encouraging for one and two-level lumbar interbody fusion in this study. Further prospective studies should be conducted to investigate safety and efficacy in a larger population.
authors.affiliation: Spine Institute of Louisiana, Shreveport, Louisiana, USA.
authors.forename: Pierce D
authors.initials: PD
authors.lastname: Nunley
authors.affiliation: Spine Institute of Louisiana, Shreveport, Louisiana, USA.
authors.forename: Eubulus J
authors.initials: EJ
authors.lastname: Kerr
authors.affiliation: Spine Institute of Louisiana, Shreveport, Louisiana, USA.
authors.forename: Philip A
authors.initials: PA
authors.lastname: Utter
authors.affiliation: Spine Institute of Louisiana, Shreveport, Louisiana, USA.
authors.forename: David A
authors.initials: DA
authors.lastname: Cavanaugh
authors.affiliation: Spine Institute of Louisiana, Shreveport, Louisiana, USA.
authors.forename: Kelly A
authors.initials: KA
authors.lastname: Frank
authors.affiliation: Spine Institute of Louisiana, Shreveport, Louisiana, USA.
authors.forename: Devan
authors.initials: D
authors.lastname: Moody
authors.affiliation: Spine Institute of Louisiana, Shreveport, Louisiana, USA.
authors.forename: Brian
authors.initials: B
authors.lastname: McManus
authors.affiliation: Spine Institute of Louisiana, Shreveport, Louisiana, USA.
authors.forename: Marcus B
authors.initials: MB
authors.lastname: Stone
keywords: Bone graft; Nucel; allograft; bioactive amniotic suspension; bone graft alternative; lumbar fusion