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Nunley PD, Kerr EJ, Utter PA, et al. Preliminary Results of Bioactive Amniotic Suspension with Allograft for Achieving One and Two-Level Lumbar Interbody Fusion. Int J Spine Surg. 2016;10:12doi: 10.14444/3012.
Nunley, P. D., Kerr, E. J., Utter, P. A., Cavanaugh, D. A., Frank, K. A., Moody, D., McManus, B., & Stone, M. B. (2016). Preliminary Results of Bioactive Amniotic Suspension with Allograft for Achieving One and Two-Level Lumbar Interbody Fusion. International journal of spine surgery, 1012. https://doi.org/10.14444/3012
Nunley, Pierce D, et al. "Preliminary Results of Bioactive Amniotic Suspension with Allograft for Achieving One and Two-Level Lumbar Interbody Fusion." International journal of spine surgery vol. 10 (2016): 12. doi: https://doi.org/10.14444/3012
Nunley PD, Kerr EJ, Utter PA, Cavanaugh DA, Frank KA, Moody D, McManus B, Stone MB. Preliminary Results of Bioactive Amniotic Suspension with Allograft for Achieving One and Two-Level Lumbar Interbody Fusion. Int J Spine Surg. 2016 Apr 18;10:12. doi: 10.14444/3012. eCollection 2016. PMID: 27162714; PMCID: PMC4852597.
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Int J Spine Surg. 2016 Apr 18;10:12. doi: 10.14444/3012. eCollection 2016.

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

International journal of spine surgery

Pierce D Nunley, Eubulus J Kerr, Philip A Utter, David A Cavanaugh, Kelly A Frank, Devan Moody, Brian McManus, Marcus B Stone

Affiliations

  1. Spine Institute of Louisiana, Shreveport, Louisiana, USA.

PMID: 27162714 PMCID: PMC4852597 DOI: 10.14444/3012

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.

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.

Keywords: Bone graft; Nucel; allograft; bioactive amniotic suspension; bone graft alternative; lumbar fusion

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