Abstract
PurposeSilicate-substituted calcium phosphate-enhanced porosity (SiCaP EP, Inductigraft™, Altapore) is a synthetic bone graft material with enhanced strut porosity of 31–47%. SiCaP EP remains to be fully clinically evaluated in patients undergoing instrumented posterolateral fusion (PLF) surgery. We conducted a prospective, open-label, non-randomised, multicentre clinical study to evaluate efficacy of SiCaP EP as bone grafting material in PLF surgery with instrumentation for treatment of spinal disorders.MethodsPatients with degenerative disc disease, spondylolisthesis or spinal stenosis underwent PLF surgery with SiCaP EP. The primary endpoint was evaluated in the per protocol population (N = 102) as solid fusion at postoperative month 12 assessed using computed tomography scans, with motion assessed using flexion–extension radiographs. Clinical outcomes included the Oswestry Disability Index, 36-item short-form health survey for quality-of-life, visual analog scale for pain scores and neurological assessments. Adverse events were recorded.ResultsSuccessful fusion was achieved in 59/89 (66.3%) patients at month 6, 88/102 patients (86.3%) at month 12 (primary endpoint) and 87/96 (90.6%) patients at month 24. Disability and pain reduced following surgery. Quality-of-life improved and neurological function was maintained postoperatively. Forty-three (33.3%) of the 129 patients who underwent surgery experienced adverse events; back pain was most frequent (n = 10); nine and 14 patients experienced serious adverse events judged related to device and procedure, respectively.ConclusionsEnhanced strut porosity SiCaP EP provided high (month 12: 86.3%) spinal fusion success rates in PLF surgery. Fusion success was associated with improved clinical outcomes in patients within 12 months, relative to baseline.ClinicalTrials.gov identifierNCT01452022Graphical abstractThese slides can be retrieved under Electronic Supplementary Material.
Highlights
Degenerative disc disease, spinal stenosis and spondylolisthesis are major spine pathologies, causing severe chronic back and leg pain, loss of motor control, neurological deficit and impaired quality-of-life [1]
The growth factor recombinant human bone morphogenetic protein-2 is licensed for spinal fusion surgery, but a meta-analysis concluded that, while it increases the probability of successful fusion, it does not translate to clinically meaningful benefits in pain reduction, function or quality of life [12]
The most frequent reason for non-completion was the requirement for revision surgery following an adverse event that led to withdrawal of the study in nine (6.9%) patients
Summary
Degenerative disc disease, spinal stenosis and spondylolisthesis are major spine pathologies, causing severe chronic back and leg pain, loss of motor control, neurological deficit and impaired quality-of-life [1]. When symptoms prove unresponsive to conservative treatments of bed rest, exercise therapy and analgesics [2, 3], patients may undergo spinal fusion surgery to eliminate motion of the vertebral body, prevent further tissue damage and relieve pain, restoring the patient’s quality of life [4]. Spinal fusion patients have increased from approximately 170,000 to 410,000 in the USA from 1998 to 2008 [5]. Cadaveric bone graft materials can be used but lack quality assurance [10] or disease-free status [11]. The growth factor recombinant human bone morphogenetic protein-2 (rhBMP-2) is licensed for spinal fusion surgery, but a meta-analysis concluded that, while it increases the probability of successful fusion, it does not translate to clinically meaningful benefits in pain reduction, function or quality of life [12]
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