{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,21]],"date-time":"2026-09-21T23:51:07Z","timestamp":1790034667411,"version":"4.0.1"},"reference-count":53,"publisher":"Journal of Neurosurgery Publishing Group (JNSPG)","issue":"6","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["SPI"],"published-print":{"date-parts":[[2014,12]]},"abstract":"<jats:sec>\n<jats:title>Object<\/jats:title>\n<jats:p>Despite limited availability and the morbidity associated with autologous iliac crest bone graft (ICBG), its use in anterior lumbar interbody fusion (ALIF) procedures remains the gold standard to achieve arthrodesis. The search for alternative grafts yielding comparable or superior fusion outcomes with fewer complications continues. In particular, i-FACTOR, a novel bone graft substitute composed of anorganic bone matrix (ABM) with P-15 small peptide, is one example currently used widely in the dental community. Although preclinical studies have documented its usefulness, the role of i-FACTOR in ALIF procedures remains unknown.<\/jats:p>\n<jats:p>The authors' goal was to determine the safety and efficacy of i-FACTOR bone graft composite used in patients who underwent ALIF by evaluating fusion rates and clinical outcomes.<\/jats:p><\/jats:sec>\n<jats:sec>\n<jats:title>Methods<\/jats:title>\n<jats:p>A nonblinded cohort of patients who were all referred to a single surgeon's practice was prospectively studied. One hundred ten patients with degenerative spinal disease underwent single or multilevel ALIF using the ABM\/P-15 bone graft composite with a mean of 24 months (minimum 15 months) of follow-up were enrolled in the study. Patient's clinical outcomes were assessed using the Oswestry Disability Index for low-back pain, the 12-Item Short Form Health Survey, Odom's criteria, and a visual analog scale for pain. Fine-cut CT scans were used to evaluate the progression to fusion.<\/jats:p><\/jats:sec>\n<jats:sec>\n<jats:title>Results<\/jats:title>\n<jats:p>All patients who received i-FACTOR demonstrated radiographic evidence of bony induction and early incorporation of bone graft. At a mean of 24 months of follow-up (range 15\u201343 months), 97.5%, 81%, and 100% of patients, respectively, who had undergone single-, double-, and triple-level surgery exhibited fusion at all treated levels. The clinical outcomes demonstrated a statistically significant (p &lt; 0.05) difference between preoperative and postoperative Oswestry Disability Index, 12-Item Short Form Health Survey, and visual analog scores.<\/jats:p><\/jats:sec>\n<jats:sec>\n<jats:title>Conclusions<\/jats:title>\n<jats:p>The use of i-FACTOR bone graft substitute demonstrates promising results for facilitating successful fusion and improving clinical outcomes in patients who undergo ALIF surgery for degenerative spinal pathologies.<\/jats:p><\/jats:sec>","DOI":"10.3171\/2014.9.spine131151","type":"journal-article","created":{"date-parts":[[2014,10,17]],"date-time":"2014-10-17T14:01:07Z","timestamp":1413554467000},"page":"867-876","source":"Crossref","is-referenced-by-count":49,"title":["Clinical outcomes and fusion rates following anterior lumbar interbody fusion with bone graft substitute i-FACTOR, an anorganic bone matrix\/P-15 composite"],"prefix":"10.3171","volume":"21","author":[{"given":"Ralph J.","family":"Mobbs","sequence":"first","affiliation":[{"name":"NeuroSpineClinic, Prince of Wales Private Hospital; and"},{"name":"Faculty of Medicine, University of New South Wales, Sydney, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Monish","family":"Maharaj","sequence":"additional","affiliation":[{"name":"Faculty of Medicine, University of New South Wales, Sydney, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Prashanth J.","family":"Rao","sequence":"additional","affiliation":[{"name":"NeuroSpineClinic, Prince of Wales Private Hospital; and"},{"name":"Faculty of Medicine, University of New South Wales, Sydney, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1754","reference":[{"key":"b1-spine131151","series-title":"Eur Spine J","doi-asserted-by":"publisher","first-page":"1323","DOI":"10.1007\/s00586-011-1782-x","article-title":"Anterior interbody arthrodesis with percutaneous posterior pedicle fixation for degenerative conditions of the lumbar spine","volume":"20","author":"Anderson","year":"2011"},{"key":"b2-spine131151","series-title":"Spine (Phila Pa 1976)","doi-asserted-by":"publisher","first-page":"1055","DOI":"10.1097\/00007632-199505000-00012","article-title":"Iliac crest bone graft harvest donor site morbidity. A statistical evaluation","volume":"20","author":"Banwart","year":"1995"},{"key":"b3-spine131151","series-title":"Eur Spine J","doi-asserted-by":"publisher","first-page":"95","DOI":"10.1007\/s00586-004-0769-2","article-title":"Failure of reconstitution of opensection, posterior iliac-wing bone graft donor sites after lumbar spinal fusion. Observations with implications for the etiology of donor site pain","volume":"14","author":"Bednar","year":"2005"},{"issue":"5 Suppl 2","key":"b4-spine131151","series-title":"Neurosurgery","first-page":"ONS423","article-title":"A comprehensive review of the safety profile of bone morphogenetic protein in spine surgery","volume":"62","author":"Benglis","year":"2008"},{"key":"b5-spine131151","series-title":"J Biomol Struct Dyn","doi-asserted-by":"publisher","first-page":"547","DOI":"10.1080\/07391102.1997.10508155","article-title":"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","volume":"14","author":"Bhatnagar","year":"1997"},{"key":"b6-spine131151","series-title":"Spine (Phila Pa 1976)","doi-asserted-by":"publisher","first-page":"566","DOI":"10.1097\/00007632-198805000-00023","article-title":"The role of anterior lumbar fusion for internal disc disruption","volume":"13","author":"Blumenthal","year":"1988"},{"key":"b7-spine131151","series-title":"Spine (Phila Pa 1976)","doi-asserted-by":"publisher","first-page":"376","DOI":"10.1097\/00007632-200002010-00020","article-title":"The use of rhBMP-2 in interbody fusion cages. Definitive evidence of osteoinduction in humans: a preliminary report","volume":"25","author":"Boden","year":"2000"},{"key":"b8-spine131151","series-title":"Spine (Phila Pa 1976)","doi-asserted-by":"publisher","first-page":"372","DOI":"10.1097\/01.BRS.0000048469.45035.B9","article-title":"Radiographic assessment of interbody fusion using recombinant human bone morphogenetic protein type 2","volume":"28","author":"Burkus","year":"2003"},{"key":"b9-spine131151","series-title":"J Spinal Disord Tech","doi-asserted-by":"publisher","first-page":"337","DOI":"10.1097\/00024720-200210000-00001","article-title":"Anterior lumbar interbody fusion using rhBMP-2 with tapered interbody cages","volume":"15","author":"Burkus","year":"2002"},{"key":"b10-spine131151","series-title":"J Bone Joint Surg Am","doi-asserted-by":"publisher","first-page":"1181","DOI":"10.2106\/JBJS.G.01485","article-title":"Six-year outcomes of anterior lumbar interbody arthrodesis with use of interbody fusion cages and recombinant human bone morphogenetic protein-2","volume":"91","author":"Burkus","year":"2009"},{"key":"b11-spine131151","series-title":"Spine (Phila Pa 1976)","doi-asserted-by":"publisher","first-page":"2396","DOI":"10.1097\/00007632-200211010-00015","article-title":"Clinical and radiographic outcomes of anterior lumbar interbody fusion using recombinant human bone morphogenetic protein-2","volume":"27","author":"Burkus","year":"2002"},{"key":"b12-spine131151","series-title":"Lancet","doi-asserted-by":"publisher","first-page":"1233","DOI":"10.1016\/S0140-6736(00)85724-4","article-title":"An operation for spondylolisthesis","volume":"221","author":"Burns","year":"1933"},{"key":"b13-spine131151","series-title":"Br J Surg","first-page":"374","article-title":"Spondylolisthesis","volume":"19","author":"Capener","year":"1932"},{"key":"b14-spine131151","series-title":"Neurosurg Rev","doi-asserted-by":"publisher","first-page":"23","DOI":"10.1007\/s10143-013-0483-9","article-title":"Current status of bone graft options for anterior interbody fusion of the cervical and lumbar spine","volume":"37","author":"Chau","year":"2014"},{"key":"b15-spine131151","series-title":"Arch Orthop Trauma Surg","doi-asserted-by":"publisher","first-page":"1725","DOI":"10.1007\/s00402-012-1607-3","article-title":"Recombinant human bone morphogenetic protein-2 versus autogenous iliac crest bone graft for lumbar fusion: a meta-analysis of ten randomized controlled trials","volume":"132","author":"Chen","year":"2012"},{"key":"b16-spine131151","series-title":"Spine (Phila Pa 1976)","doi-asserted-by":"publisher","first-page":"1385","DOI":"10.1097\/01.BRS.0000067093.47584.CA","article-title":"Reduction of disc space distraction after anterior lumbar interbody fusion with autologous iliac crest graft","volume":"28","author":"Cheung","year":"2003"},{"issue":"371","key":"b17-spine131151","series-title":"Clin Orthop Relat Res","first-page":"38","article-title":"The use of allograft bone in lumbar spine surgery","author":"Ehrler","year":"2000"},{"key":"b18-spine131151","series-title":"Spine (Phila Pa 1976)","doi-asserted-by":"publisher","first-page":"2940","DOI":"10.1097\/00007632-200011150-00017","article-title":"The Oswestry Disability Index","volume":"25","author":"Fairbank","year":"2000"},{"key":"b19-spine131151","series-title":"Am J Orthop","first-page":"895","article-title":"Complications associated with harvesting autogenous iliac bone graft","volume":"24","author":"Fowler","year":"1995"},{"key":"b20-spine131151","series-title":"Eur Spine J","doi-asserted-by":"publisher","first-page":"225","DOI":"10.1007\/BF02221598","article-title":"Anterior lumbar fusion: results, assessment techniques and prognostic factors","volume":"3","author":"Greenough","year":"1994"},{"key":"b21-spine131151","series-title":"Int Orthop","doi-asserted-by":"publisher","first-page":"93","DOI":"10.1007\/s00264-006-0087-x","article-title":"P-15 small peptide bone graft substitute in the treatment of non-unions and delayed union. A pilot clinical trial","volume":"31","author":"Gomar","year":"2007"},{"key":"b22-spine131151","series-title":"Neurosurgery","first-page":"510","article-title":"Persistent iliac crest donor site pain: independent outcome assessment","volume":"50","author":"Heary","year":"2002"},{"key":"b23-spine131151","series-title":"J Spinal Disord","doi-asserted-by":"publisher","first-page":"91","DOI":"10.1097\/00002517-200104000-00001","article-title":"Minimum 10-year follow-up study of anterior lumbar interbody fusion for isthmic spondylolisthesis","volume":"14","author":"Ishihara","year":"2001"},{"key":"b24-spine131151","series-title":"J Bone Miner Res","first-page":"1681","article-title":"Stimulatory effect of bone morphogenetic protein-2 on osteoclast-like cell formation and bone-resorbing activity","volume":"10","author":"Kanatani","year":"1995"},{"key":"b25-spine131151","series-title":"Spine J","doi-asserted-by":"publisher","first-page":"404","DOI":"10.1016\/j.spinee.2010.02.022","article-title":"Minimally invasive anterior lumbar interbody fusion followed by percutaneous pedicle screw fixation for isthmic spondylolisthesis: minimum 5-year follow-up","volume":"10","author":"Kim","year":"2010"},{"key":"b26-spine131151","series-title":"World Neurosurg","doi-asserted-by":"publisher","first-page":"565","DOI":"10.1016\/j.wneu.2010.02.057","article-title":"Comparison study of the instrumented circumferential fusion with instrumented anterior lumbar interbody fusion as a surgical procedure for adult low-grade isthmic spondylolisthesis","volume":"73","author":"Kim","year":"2010"},{"key":"b27-spine131151","series-title":"Spine (Phila Pa 1976)","doi-asserted-by":"publisher","first-page":"2751","DOI":"10.1097\/00007632-200112150-00026","article-title":"Laparoscopic anterior lumbar interbody fusion with rhBMP-2: a prospective study of clinical and radiographic outcomes","volume":"26","author":"Kleeman","year":"2001"},{"key":"b28-spine131151","series-title":"Implant Dent","doi-asserted-by":"publisher","first-page":"171","DOI":"10.1097\/01.ID.0000127522.14067.11","article-title":"Growth and proliferation of human osteoblasts on different bone graft substitutes: an in vitro study","volume":"13","author":"K\u00fcbler","year":"2004"},{"key":"b29-spine131151","series-title":"Spine (Phila Pa 1976)","doi-asserted-by":"publisher","first-page":"1324","DOI":"10.1097\/00007632-198912000-00009","article-title":"Harvesting autogenous iliac bone grafts. A review of complications and techniques","volume":"14","author":"Kurz","year":"1989"},{"key":"b30-spine131151","series-title":"Neurol Med Chir (Tokyo)","doi-asserted-by":"publisher","first-page":"645","DOI":"10.2176\/nmc.50.645","article-title":"Two-level anterior lumbar interbody fusion with percutaneous pedicle screw fixation: a minimum 3-year follow-up study","volume":"50","author":"Lee","year":"2010"},{"issue":"5 Suppl","key":"b31-spine131151","series-title":"Orthopedics","first-page":"s585","article-title":"Use of an advanced formulation of beta-tricalcium phosphate as a bone extender in interbody lumbar fusion","volume":"25","author":"Linovitz","year":"2002"},{"key":"b32-spine131151","series-title":"Spine J","doi-asserted-by":"publisher","first-page":"527","DOI":"10.1016\/j.spinee.2010.07.005","article-title":"Promoting fusion in minimally invasive lumbar interbody stabilization with low-dose bone morphogenic protein-2\u2014but what is the cost?","volume":"11","author":"Mannion","year":"2011"},{"key":"b33-spine131151","series-title":"Cerapedics","article-title":"Prospective, randomized, controlled trial demonstrates 98% fusion rate at 6-months and 12-months with i-FACTOR\u2122 biologic bone graft and superiority versus autograft in single- and multi-level PLIF spine surgery","author":"McAdoo"},{"key":"b34-spine131151","series-title":"Edinburgh Med J","first-page":"545","article-title":"Spondylolisthesis: with a description of a new method of operative treatment and notes of ten cases","volume":"43","author":"Mercer","year":"1936"},{"key":"b35-spine131151","series-title":"Orthop Surg","doi-asserted-by":"publisher","first-page":"77","DOI":"10.1111\/os.12030","article-title":"Bone graft substitutes for anterior lumbar interbody fusion","volume":"5","author":"Mobbs","year":"2013"},{"key":"b36-spine131151","series-title":"Orthop Surg","doi-asserted-by":"publisher","first-page":"153","DOI":"10.1111\/os.12048","article-title":"Indications for anterior lumbar interbody fusion","volume":"5","author":"Mobbs","year":"2013"},{"key":"b37-spine131151","series-title":"J Spinal Disord Tech","doi-asserted-by":"publisher","first-page":"18","DOI":"10.1097\/01.bsd.0000133509.99670.95","article-title":"Anterior lumbar interbody fusion: changes in area of the dural tube, disc height, and prevalence of cauda equina adhesion in magnetic resonance images","volume":"18","author":"Motosuneya","year":"2005"},{"key":"b38-spine131151","series-title":"Spine (Phila Pa 1976)","doi-asserted-by":"publisher","first-page":"831","DOI":"10.1097\/00007632-199207000-00017","article-title":"Anterior lumbar interbody fusion for internal disc disruption","volume":"17","author":"Newman","year":"1992"},{"key":"b39-spine131151","series-title":"J Orthop Sci","doi-asserted-by":"publisher","first-page":"352","DOI":"10.1007\/s00776-011-0088-5","article-title":"Single-level instrumented posterolateral fusion versus non-instrumented anterior interbody fusion for lumbar spondylolisthesis: a prospective study with a 2-year follow-up","volume":"16","author":"Ohtori","year":"2011"},{"key":"b40-spine131151","series-title":"Spine (Phila Pa 1976)","doi-asserted-by":"publisher","first-page":"1893","DOI":"10.1097\/01.brs.0000137067.68630.70","article-title":"Good outcome and restoration of lordosis after anterior lumbar interbody fusion with additional posterior fixation","volume":"29","author":"Pavlov","year":"2004"},{"key":"b41-spine131151","series-title":"Eur Spine J","first-page":"425","article-title":"Comparison of conventional versus minimally invasive extraperitoneal approach for anterior lumbar interbody fusion","volume":"13","author":"Saraph","year":"2004"},{"key":"b42-spine131151","series-title":"Eur Spine J","doi-asserted-by":"publisher","first-page":"2156","DOI":"10.1007\/s00586-010-1546-z","article-title":"Evaluation of ABM\/P-15 versus autogenous bone in an ovine lumbar interbody fusion model","volume":"19","author":"Sherman","year":"2010"},{"key":"b43-spine131151","series-title":"Spine (Phila Pa 1976)","doi-asserted-by":"publisher","first-page":"838","DOI":"10.1097\/01.brs.0000157473.17313.6f","article-title":"Fluoroscopically assisted percutaneous translaminar facet screw fixation following anterior lumbar interbody fusion: technical report","volume":"30","author":"Shim","year":"2005"},{"key":"b44-spine131151","series-title":"Spine J","doi-asserted-by":"publisher","first-page":"301","DOI":"10.1016\/j.spinee.2006.10.015","article-title":"Accelerating lumbar fusions by combining rhBMP-2 with allograft bone: a prospective analysis of interbody fusion rates and clinical outcomes","volume":"7","author":"Slosar","year":"2007"},{"key":"b45-spine131151","series-title":"J Bone Joint Surg Br","first-page":"677","article-title":"Donor site pain from the ilium. A complication of lumbar spine fusion","volume":"71","author":"Summers","year":"1989"},{"key":"b46-spine131151","series-title":"Spine (Phila Pa 1976)","doi-asserted-by":"publisher","first-page":"1251","DOI":"10.1097\/BRS.0b013e3181a005d7","article-title":"A prospective, randomized, blinded, single-site study to evaluate the clinical and radiographic differences between frozen and freeze-dried allograft when used as part of a circumferential anterior lumbar interbody fusion procedure","volume":"34","author":"Thalgott","year":"2009"},{"key":"b47-spine131151","series-title":"Spine (Phila Pa 1976)","doi-asserted-by":"publisher","first-page":"E518","DOI":"10.1097\/00007632-200212150-00011","article-title":"Anterior lumbar interbody fusion with processed sea coral (coralline hydroxyapatite) as part of a circumferential fusion","volume":"27","author":"Thalgott","year":"2002"},{"issue":"324","key":"b48-spine131151","series-title":"Clin Orthop Relat Res","first-page":"153","article-title":"Anterior interbody lumbar fusion in severe low back pain","author":"Tiusanen","year":"1996"},{"key":"b49-spine131151","series-title":"Summary of Safety and Effectiveness Data. InFUSE\u2122 Bone Graft\/LT-CAGE\u2122 Lumbar Tapered Fusion Device","author":"US Food and Drug Administration"},{"key":"b50-spine131151","series-title":"Spine J","doi-asserted-by":"publisher","first-page":"206","DOI":"10.1016\/S1529-9430(02)00180-8","article-title":"Bone grafting alternatives in spinal surgery","volume":"2","author":"Vaccaro","year":"2002"},{"key":"b51-spine131151","series-title":"J Bone Joint Surg Br","first-page":"342","article-title":"Interbody fusion with allograft and rhBMP-2 leads to consistent fusion but early subsidence","volume":"89","author":"Vaidya","year":"2007"},{"key":"b52-spine131151","series-title":"Med Care","doi-asserted-by":"publisher","first-page":"220","DOI":"10.1097\/00005650-199603000-00003","article-title":"A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity","volume":"34","author":"Ware","year":"1996"},{"key":"b53-spine131151","series-title":"Spine (Phila Pa 1976)","doi-asserted-by":"publisher","first-page":"1685","DOI":"10.1097\/BRS.0b013e318216d825","article-title":"Does bone morphogenetic protein increase the incidence of perioperative complications in spinal fusion? A comparison of 55,862 cases of spinal fusion with and without bone morphogenetic protein","volume":"36","author":"Williams","year":"2011"}],"container-title":["Journal of Neurosurgery: Spine"],"original-title":[],"link":[{"URL":"https:\/\/thejns.org\/view\/journals\/j-neurosurg-spine\/21\/6\/article-p867.xml","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/thejns.org\/downloadpdf\/journals\/j-neurosurg-spine\/21\/6\/article-p867.xml","content-type":"text\/html","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/thejns.org\/downloadpdf\/journals\/j-neurosurg-spine\/21\/6\/article-p867.xml","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,4,15]],"date-time":"2023-04-15T23:04:59Z","timestamp":1681599899000},"score":1,"resource":{"primary":{"URL":"https:\/\/thejns.org\/view\/journals\/j-neurosurg-spine\/21\/6\/article-p867.xml"}},"subtitle":["Clinical article"],"short-title":[],"issued":{"date-parts":[[2014,12]]},"references-count":53,"journal-issue":{"issue":"6"},"URL":"https:\/\/doi.org\/10.3171\/2014.9.spine131151","relation":{},"ISSN":["1547-5654"],"issn-type":[{"value":"1547-5654","type":"print"}],"subject":[],"published":{"date-parts":[[2014,12]]}}}