Prospective analysis of a new bone graft in lumbar interbody fusion: results of a 2- year prospective clinical and radiological study

Philippe Lauweryns, Yannic Raskin, Philippe Lauweryns, Yannic Raskin

Abstract

Background: This study examined the efficacy and safety of bone graft material ABM/P-15 (iFACTOR) for use in posterior lumbar interbody fusion. ABM/P-15 has been used safely for more than a decade in dental applications.

Methods: Forty patients underwent PLIF surgery, with each patient as control. Assessments up to 24 months included radiographs, CT scan, VAS, and ODI. Primary success criteria were fusion and safety.

Results: Intra-cage bridging bone occurred earlier with ABM/P-15 than autograft (97.73% vs. 59.09% at 6 months). On average pain decreased 29 points and function improved 43 points. Radio dense material outside the disk space occurred more frequently with ABM/P-15 than autograft, without clinical consequence.

Conclusions: This study suggests that ABM/P-15 has equal or greater efficacy at 6 and 12 months. Pain improvements exceeded success criteria at all time points. Functional improvement exceeded success criteria at all time points.

Clinical relevance: This study explores the safety and efficacy of an osteobiologic peptide enhanced bone graft material as a viable alternative to autograft and its attendant risks.

Keywords: ABM/P-15; P-15; PLIF; bone graft alternative; lumbar fusion; peptide.

Figures

Figure 1
Figure 1
PLIF Cages/Study Model.
Figure 2
Figure 2
Intra-cage zones for assessing fusion.
Figure 3
Figure 3
Patient Outcomes.
Figure 4
Figure 4
Radiology analysis/methodology; 40 patients, 45 levels.
Figure 5
Figure 5
Occurrence by zone.

References

    1. Spoor AB, Oner FC. Minimally invasive spine surgery in chronic low back pain patients. J Neurosurg Sci. 2013;57(3):203–218.
    1. Costa F, Sassi M, Ortolina A, Cardia A, Assietti R, Zerbi A, Lorenzetti M, Galbusera F, Fornari M. Stand-alone cage for posterior lumbar interbody fusion in the treatment of high-degree degenerative disc disease: design of a new device for an “old” technique. A prospective study on a series of 116 patients. Eur Spine J. 2011;20(Suppl 1):S46–56. Available from:
    1. Sawin PD, Traynelis VC, Menezes AH. A comparative analysis of fusion rates and donor-site morbidity for autogeneic rib and iliac crest bone grafts in posterior cervical fusions. J Neurosurg. 1998;88(2):255–65.
    1. Burkus JK, Gornet MF, Dickman CA, Zdeblick TA. Anterior lumbar interbody fusion using rhBMP-2 with tapered interbody cages. J Spinal Disord Tech. 2002;15:337–49.
    1. Dimitriou R, Mataliotakis GI, Angoules AG, Kanakaris NK, Giannoudis PV. Complications following autologous bone graft harvesting from the iliac crest and using the RIA: a systematic review. Injury. 2011;42(Suppl 2):S3–15. doi: 10.1016/j.injury.2011.06.015.
    1. DeLong WG, Jr, Einhorn TA, Koval K, McKee M, Smith W, Sanders R, Watson T. Bone grafts and bone graft substitutes in orthopaedic trauma surgery. A critical analysis. J Bone Joint Surg Am. 2007;89:649–58.
    1. Abdullah KG, Steinmetz MP, Benzel EC, Mroz TE. The state of lumbar fusion extenders. Spine (Phila Pa 1976) 2011;36(20):E1328–34. doi: 10.1097/BRS.0b013e318209952b.
    1. Simmonds MC, Brown JV, Heirs MK, Higgins JP, Mannion RJ, Rodgers MA, Stewart LA. Safety and effectiveness of recombinant human bone morphogenetic protein-2 for spinal fusion: a meta-analysis of individual-participant data. Ann Intern Med. 2013;158(12):877–89.
    1. Rodgers MA, Brown JV, Heirs MK, Higgins JP, Mannion RJ, Simmonds MC, Stewart LA. Reporting of industry funded study outcome data: comparison of confidential and published data on the safety and effectiveness of rhBMP-2 for spinal fusion. BMJ. 2013;346:f3981.
    1. Fu R, Selph S, McDonagh M, Peterson K, Tiwari A, Chou R, Helfand M. Effectiveness and harms of recombinant human bone morphogenetic protein-2 in spine fusion: a systematic review and aeta-analysis. Ann Intern Med. 2013;158(12):890–902.
    1. Resnick D, Bozic KJ. Meta-analysis of trials of recombinant human bone morphogenetic protein-2: What should spine surgeons and their patients do with this information? Ann Intern Med. 2013;158(12):912–13.
    1. Carragee EJ, Hurwitz EL, Weiner BK. A critical review of recombinant human bone morphogenetic protein-2 trials in spinal surgery: emerging safety concerns and lessons learned. Spine J. 2011;11(6):471–91.
    1. Sherman BP, Lindley EM, Turner AS, Seim HB, 3rd, Benedict J, Burger EL, Patel VV. Evaluation of ABM/P-15 versus autogenous bone in an ovine lumbar interbody fusion model. Eur Spine J. 2010;19(12):2156–63.
    1. Gomar F, Orozco R, Villar JL, Arrizabalaga F. P-15 small peptide bone graft substitute in the treatment of non-unions and delayed union. A pilot clinical trial. Int Orthop. 2007;31(1):93–99.
    1. Yang XB, Bhatnager RS, Li S, Oreffo ROC. Biomimetic collagen scaffolds for human bone cell growth and differentiation. Tissue Eng. 2004;10(7-8):1148–59.
    1. Qian JJ, Bhatnagar RS. Enhanced cell attachment to anorganic bone mineral in the presence of a synthetic peptide related to collagen. J Biomed Materials Res. 1996;31(4):545–54.
    1. Bhatnagar RS, Qian JJ, Gough CA. The role in cell binding of a beta-bend within the triple helical region in collagen alpha 1 (I) chain: structural and biological evidence for conformational tautomerism on fiber surface. J Biomol Struct Dyn. 1997;14(5):547–60.
    1. Yukna RA, Callan DP, Krauser JT, Evans GH, Aichelmann-Reidy ME, Moore K, et al. Multi-center clinical evaluation of combination anorganic bovine bone-derived hydroxyapatite matrix (ABM)/cell-binding peptide (P-15) and ABM in human periodontal osseous defects: 6-month results. J Periodontol. 1998;69:655–63.
    1. Yukna RA, Krauser JT, Callan DP, Evans GH, Cruz R, Martin M. Multi-center clinical comparison of combination anorganic bovine bone-derived hydroxyapatite matrix (ABM)/cell-binding peptide (P-15) and ABM in human periodontal osseous defects: 6-month results. J Periodontol. 2000;71(11):1671–79.
    1. Haag O, Fritzell P, Nordwall A. The clinical importance of changes in outcomes scores after treatment for chronic low back pain. Eur Spine J. 2003;12(1):12–20.
    1. Ostelo RW, Costa LO, Maher CG, de Vet HC, van Tulder MW. Rehabilitation after lumbar disk surgery. Cochrane Database Syst Rev. 2008;(4):CD003007. doi: 10.1002/14651858.CD003007.pub2..
    1. Joseph V, Rampersaud YR. Heterotopic bone formation with the use of rhBMP2 in posterior minimal access interbody fusion. A CT analysis. Spine (Phila Pa 1976) 2007;32(25):2885–90.
    1. Kim SU, Yang TK, Lee JC., MD Radiological changes in the bone fusion site after posterior lumbar interbody fusion using carbon cages impacted with laminar bone chips: follow-up study over more than 4 years. Spine (Phila Pa 1976) 2005;30(6):655–60.
    1. Brower RS, Vickroy NM. A case of psoas ossification from the use of BMP-2 for posterolateral fusion at L4–L5. Spine (Phila Pa 1976) 2008;33(18):E653–55.
    1. Glassman SD, Howard JM, Sweet A, Carreon LY. Complications and concerns with osteobiologics for spine fusion in clinical practice. Spine (Phila Pa 1976) 2010;35(17):1621–28.
    1. Haid RW, Branch CL, Jr, Alexander JT, Burkus JK. Posterior lumbar interbody fusion using recombinant human bone morphogenetic protein type 2 with cylindrical interbody cages. Spine J. 2004;4(5):527–38.
    1. Mobbs RJ, Loganathan A, Yeung V, Rao PJ. Indications for anterior lumbar interbody fusion. Orthop Surg. 2013;5(3):153–63.
    1. Brandoff JF, Silber JS, Vaccaro AR. Contemporary alternatives to synthetic bone grafts for spine surgery. Am J Orthop. 2008;37(8):410–14.
    1. Boden SD, Zdeblick TA, Sandhu HS, Heim SE. The use of rhBMP-2 in interbody fusion cages. Definitive evidence of osteoinduction in humans: a preliminary report. Spine (Phila Pa 1976) 2000;25(3):376–81.
    1. Wong DA, Kumar A, Jatana S, Ghiselli G, Wong K. Neurologic impairment from ectopic bone in the lumbar canal: a potential complication of off-label PLIF/TLIF use of bone morphogenetic protein-2 (BMP-2) Spine J. 2008;8(6):1011–18.
    1. Chen NF, Smith ZA, Stiner E, Armin S, Sheikh H, Khoo LT. Symptomatic ectopic bone formation after off-label use of recombinant human bone morphogenetic protein-2 in transforaminal lumbar interbody fusion. J Neurosurg Spine. 2010;12(1):40–46.

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