Ciaran Bolger1, Drew Jones2,3, Steven Czop3. 1. Beaumont Hospital, PO Box 1297, Beaumont Road, Dublin 9, Republic of Ireland. cbolger007@icloud.com. 2. Beaumont Hospital, PO Box 1297, Beaumont Road, Dublin 9, Republic of Ireland. 3. Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL, 60015, USA.
Abstract
PURPOSE: Silicate-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. METHODS: Patients 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. RESULTS: Successful 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. CONCLUSIONS: Enhanced 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 IDENTIFIER: NCT01452022 These slides can be retrieved under Electronic Supplementary Material.
PURPOSE:Silicate-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. METHODS:Patients 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. RESULTS: Successful 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. CONCLUSIONS: Enhanced 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 IDENTIFIER: NCT01452022 These slides can be retrieved under Electronic Supplementary Material.
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