Arnold PM, Sasso RC, Janssen ME, Fehlings MG, Heary RF, Vaccaro AR, Kopjar B i-Factor Bone Graft vs Autograft in Anterior Cervical Discectomy and Fusion: 2-Year Follow-up of the Randomized Single-Blinded Food and Drug Administration Investigational Device Exemption Study. Neurosurgery. 2018 Sep 1;83(3):377-384. doi: 10.1093/neuros/nyx432.
Arutyunyan GG, Angevine PD, Berven S Cost-Effectiveness in Adult Spinal Deformity Surgery. Neurosurgery. 2018 Oct 1;83(4):597-601. doi: 10.1093/neuros/nyx575. Erratum In: Neurosurgery. 2019 Mar 1;84(3):815.
Axelsen MG, Overgaard S, Jespersen SM, Ding M Comparison of synthetic bone graft ABM/P-15 and allograft on uninstrumented posterior lumbar spine fusion in sheep. J Orthop Surg Res. 2019 Jan 3;14(1):2. doi: 10.1186/s13018-018-1042-4.
Bari TJ, Hansen LV, Gehrchen M Surgical correction of Adult Spinal Deformity in accordance to the Roussouly classification: effect on postoperative mechanical complications. Spine Deform. 2020 Oct;8(5):1027-1037. doi: 10.1007/s43390-020-00112-6. Epub 2020 Apr 11.
Blanco JS, Sears CJ Allograft bone use during instrumentation and fusion in the treatment of adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 1997 Jun 15;22(12):1338-42. doi: 10.1097/00007632-199706150-00011.
Brantigan JW, Steffee AD, Lewis ML, Quinn LM, Persenaire JM Lumbar interbody fusion using the Brantigan I/F cage for posterior lumbar interbody fusion and the variable pedicle screw placement system: two-year results from a Food and Drug Administration investigational device exemption clinical trial. Spine (Phila Pa 1976). 2000 Jun 1;25(11):1437-46. doi: 10.1097/00007632-200006010-00017.
Burkus JK, Gornet MF, Schuler TC, Kleeman TJ, Zdeblick TA Six-year outcomes of anterior lumbar interbody arthrodesis with use of interbody fusion cages and recombinant human bone morphogenetic protein-2. J Bone Joint Surg Am. 2009 May;91(5):1181-9. doi: 10.2106/JBJS.G.01485.
Cheng I, Oshtory R, Wildstein MS The role of osteobiologics in spinal deformity. Neurosurg Clin N Am. 2007 Apr;18(2):393-401. doi: 10.1016/j.nec.2007.01.002.
Daubs MD, Lenke LG, Cheh G, Stobbs G, Bridwell KH Adult spinal deformity surgery: complications and outcomes in patients over age 60. Spine (Phila Pa 1976). 2007 Sep 15;32(20):2238-44. doi: 10.1097/BRS.0b013e31814cf24a.
Ehrler DM, Vaccaro AR The use of allograft bone in lumbar spine surgery. Clin Orthop Relat Res. 2000 Feb;(371):38-45. doi: 10.1097/00003086-200002000-00005.
Fatima G, Shivamurthy R, Thakur S, Baseer MA Evaluation of anorganic bovine-derived hydroxyapatite matrix/cell binding peptide as a bone graft material in the treatment of human periodontal infrabony defects: A clinico-radiographic study. J Indian Soc Periodontol. 2015 Nov-Dec;19(6):651-8. doi: 10.4103/0972-124X.164766.
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 Feb;31(1):93-9. doi: 10.1007/s00264-006-0087-x. Epub 2006 Jun 8.
Kannan A, Dodwad SN, Hsu WK Biologics in spine arthrodesis. J Spinal Disord Tech. 2015 Jun;28(5):163-70. doi: 10.1097/BSD.0000000000000281.
Karstensen S, Bari T, Gehrchen M, Street J, Dahl B Morbidity and mortality of complex spine surgery: a prospective cohort study in 679 patients validating the Spine AdVerse Event Severity (SAVES) system in a European population. Spine J. 2016 Feb;16(2):146-53. doi: 10.1016/j.spinee.2015.09.051. Epub 2015 Oct 8.
Kirzner N, Hilliard L, Martin C, Quan G, Liew S, Humadi A Bone graft in posterior spine fusion for adolescent idiopathic scoliosis: a meta-analysis. ANZ J Surg. 2018 Dec;88(12):1247-1252. doi: 10.1111/ans.14551. Epub 2018 May 15.
Kubler A, Neugebauer J, Oh JH, Scheer M, Zoller JE Growth and proliferation of human osteoblasts on different bone graft substitutes: an in vitro study. Implant Dent. 2004 Jun;13(2):171-9. doi: 10.1097/01.id.0000127522.14067.11.
Lauweryns P, Raskin Y Prospective analysis of a new bone graft in lumbar interbody fusion: results of a 2- year prospective clinical and radiological study. Int J Spine Surg. 2015 Feb 3;9:2. doi: 10.14444/2002. eCollection 2015.
Loenen ACY, Connor J, Johnson S, Davis K, Hannigan N, Barnes T, Arts JJ, van Rietbergen B Peptide Enhanced Bone Graft Substitute Presents Improved Short-Term Increase in Bone Volume and Construct Stiffness Compared to Iliac Crest Autologous Bone in an Ovine Lumbar Interbody Fusion Model. Global Spine J. 2022 Sep;12(7):1330-1337. doi: 10.1177/2192568220979839. Epub 2021 Jan 7.
Mishra PRN, Kolte AP, Kolte RA, Pajnigara NG, Shah KK Comparative evaluation of open flap debridement alone and in combination with anorganic bone matrix/cell-binding peptide in the treatment of human infrabony defects: A randomized clinical trial. J Indian Soc Periodontol. 2019 Jan-Feb;23(1):42-47. doi: 10.4103/jisp.jisp_339_18.
Mobbs RJ, Maharaj M, Rao PJ Clinical outcomes and fusion rates following anterior lumbar interbody fusion with bone graft substitute i-FACTOR, an anorganic bone matrix/P-15 composite. J Neurosurg Spine. 2014 Dec;21(6):867-76. doi: 10.3171/2014.9.SPINE131151. Epub 2014 Oct 17.
MOE JH A critical analysis of methods of fusion for scoliosis; an evaluation in two hundred and sixty-six patients. J Bone Joint Surg Am. 1958 Jun;40-A(3):529-54 passim. No abstract available.
Ni J, Zheng Y, Liu N, Wang X, Fang X, Phukan R, Wood KB Radiological evaluation of anterior lumbar fusion using PEEK cages with adjacent vertebral autograft in spinal deformity long fusion surgeries. Eur Spine J. 2015 Apr;24(4):791-9. doi: 10.1007/s00586-014-3745-5. Epub 2015 Jan 25.
Pape HC, Evans A, Kobbe P Autologous bone graft: properties and techniques. J Orthop Trauma. 2010 Mar;24 Suppl 1:S36-40. doi: 10.1097/BOT.0b013e3181cec4a1.
Qian JJ, Bhatnagar RS Enhanced cell attachment to anorganic bone mineral in the presence of a synthetic peptide related to collagen. J Biomed Mater Res. 1996 Aug;31(4):545-54. doi: 10.1002/(SICI)1097-4636(199608)31:43.0.CO;2-F.
Raman T, Nayar SK, Liu S, Skolasky RL, Kebaish KM Cost-Effectiveness of Primary and Revision Surgery for Adult Spinal Deformity. Spine (Phila Pa 1976). 2018 Jun 1;43(11):791-797. doi: 10.1097/BRS.0000000000002481.
Strube P, Hoff E, Hartwig T, Perka CF, Gross C, Putzier M Stand-alone anterior versus anteroposterior lumbar interbody single-level fusion after a mean follow-up of 41 months. J Spinal Disord Tech. 2012 Oct;25(7):362-9. doi: 10.1097/BSD.0b013e3182263d91.
Yang XB, Bhatnagar RS, Li S, Oreffo RO Biomimetic collagen scaffolds for human bone cell growth and differentiation. Tissue Eng. 2004 Jul-Aug;10(7-8):1148-59. doi: 10.1089/ten.2004.10.1148.
Yeramaneni S, Robinson C, Hostin R Impact of spine surgery complications on costs associated with management of adult spinal deformity. Curr Rev Musculoskelet Med. 2016 Sep;9(3):327-32. doi: 10.1007/s12178-016-9352-9.
Yukna RA, Krauser JT, Callan DP, Evans GH, Cruz R, Martin M Multi-center clinical comparison of combination anorganic bovine-derived hydroxyapatite matrix (ABM)/cell binding peptide (P-15) and ABM in human periodontal osseous defects. 6-month results. J Periodontol. 2000 Nov;71(11):1671-9. doi: 10.1902/jop.2000.71.11.1671. Erratum In: J Periodontol 2001 Apr;72(4):570. J Periodontol. 2001 Apr;72 (4):570.
Yukna RA, Krauser JT, Callan DP, Evans GH, Cruz R, Martin M Thirty-six month follow-up of 25 patients treated with combination anorganic bovine-derived hydroxyapatite matrix (ABM)/cell-binding peptide (P-15) bone replacement grafts in human infrabony defects. I. Clinical findings. J Periodontol. 2002 Jan;73(1):123-8. doi: 10.1902/jop.2002.73.1.123.
ABM/P-15 Bone Graft vs Traditional Bone Graft in Adult Spinal Deformity Surgery - a Randomized Controlled Clinical Trial
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.