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. CONCLUSION: 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.
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. CONCLUSION: 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.
Entities:
Keywords:
Bone graft; Nucel; allograft; bioactive amniotic suspension; bone graft alternative; lumbar fusion
Authors: Rozalia Dimitriou; George I Mataliotakis; Antonios G Angoules; Nikolaos K Kanakaris; Peter V Giannoudis Journal: Injury Date: 2011-06-25 Impact factor: 2.586
Authors: Lisa B E Shields; George H Raque; Steven D Glassman; Mitchell Campbell; Todd Vitaz; John Harpring; Christopher B Shields Journal: Spine (Phila Pa 1976) Date: 2006-03-01 Impact factor: 3.468
Authors: Gregory M Malham; Rhiannon M Parker; Ngaire J Ellis; Carl M Blecher; Fiona Y Chow; Matthew H Claydon Journal: J Neurosurg Spine Date: 2014-10-03
Authors: John P McQuilling; Miranda Burnette; Kelly A Kimmerling; MaryRose Kammer; Katie C Mowry Journal: Wound Repair Regen Date: 2019-08-29 Impact factor: 3.617
Authors: Laura de Girolamo; Luiz Felipe Morlin Ambra; Carlotta Perucca Orfei; John P McQuilling; Kelly A Kimmerling; Katie C Mowry; Kimberly A Johnson; Amy T Phan; Jessica L Whited; Andreas H Gomoll Journal: Cells Date: 2019-11-08 Impact factor: 6.600