scholarly journals Evaluation of an increased strut porosity silicate-substituted calcium phosphate, SiCaP EP, as a synthetic bone graft substitute in spinal fusion surgery: a prospective, open-label study

2019 ◽  
Vol 28 (7) ◽  
pp. 1733-1742 ◽  
Author(s):  
Ciaran Bolger ◽  
Drew Jones ◽  
Steven Czop
Author(s):  
Grant Steen

Background: Use of synthetic bone graft substitutes for spinal fusion has increased sharply over the past 20 years. SIGNAFUSE® is one such synthetic graft material that provides an osteostimulatory effect for spinal fusion. Because clinical trials are not required for commercialization of synthetic bone graft substitutes in the United States, fusion rates attained using SIGNAFUSE for lumbar fusion are not well documented. The goal of the current study is to determine the rate of spinal fusion in a military clinic following lumbar fusion surgery augmented with SIGNAFUSE. Methods: We report a retrospective chart review of 8 patients who received lumbar spinal fusion surgery augmented with SIGNAFUSE. All patients were assessed by computed tomographic (CT) imaging at least 1-year post-surgery to determine whether bony fusion had occurred. We also systematically reviewed literature sources that report fusion rate following spinal fusion surgery, for broader context. Results: An average of 1.6 spinal levels were treated with SIGNAFUSE-loaded interbody cages. All patients had stabilization hardware via pedicle screws or integrated cage fixation. Seven of 8 patients successfully fused, for an overall fusion rate of 87.5% (95% confidence interval: 47.4% to 99.7%). Systematic review of 26 recent publications that included 1,126 patients treated with synthetic bone graft showed that the overall fusion rate in the literature is 84.4%. Conclusions: Fusion was achieved in 87.5% of patients treated with SIGNAFUSE. This is comparable to the fusion rate in a systematic review of 1,126 patients treated with synthetic bone graft materials.


2021 ◽  
Vol 108 (Supplement_2) ◽  
Author(s):  
A Aljawadi ◽  
I Madhi ◽  
T Naylor ◽  
M Elmajee ◽  
A Islam ◽  
...  

Abstract Background Management of traumatic bone void associated with Gustilo IIIB open fractures is challenging. Gentamicin eluting synthetic bone graft substitute (Cerament-G) had been recently utilised for the management of patients with these injuries. This study aims to assess radiological signs of Cerament-G remodelling. Method Retrospective data analysis of all patients admitted to our unit with IIIB open fractures who had Cerament-G applied as avoid filler. Postoperative radiographic images of the fracture site at 6-weeks, 3-months, 6-months and at the last follow-up were reviewed. The radiological signs of Cerament-G integration, percent of void healing, and bone cortical thickness at the final follow-up were assessed. Results 34 patients met our inclusion criteria, mean age: 42 years. Mean follow-up time was 20 months. 59% of patients had excellent (>90%) void filling, 26.4% of patients had 50-90% void filling, and 14.6% had < 50% void filling. Normal bone cortical thickness was restored on AP and Lateral views in 55.8% of patients. No residual Cerement-G was seen on X-rays at the final follow-up in any of the patients. Conclusions Our results showed successful integration of Cerament-G with excellent void filling and normal cortical thickness achieved in more than half of the patients.


2020 ◽  
Vol Publish Ahead of Print ◽  
Author(s):  
Carl Nunziato ◽  
John Williams ◽  
Ronald Williams

Apmis ◽  
2019 ◽  
Vol 127 (2) ◽  
pp. 53-63 ◽  
Author(s):  
Werner Hettwer ◽  
Peter F. Horstmann ◽  
Sabine Bischoff ◽  
Daniel Güllmar ◽  
Jürgen R. Reichenbach ◽  
...  

2016 ◽  
Vol 67 (1) ◽  
pp. 21-27 ◽  
Author(s):  
Victoria Tan ◽  
Nathan Evaniew ◽  
Karen Finlay ◽  
Erik Jurriaans ◽  
Michelle Ghert ◽  
...  

Purpose The objective of the study was to characterize the radiographic appearance of graft resorption and new bone incorporation into a postresection defect of the calcium-sulfate calcium-phosphate synthetic bone graft composite following resection of benign bone tumours. Methods Twenty-five patients who underwent treatment with the CaSO4/CaPO4 synthetic graft following bone tumour resection were retrospectively identified from our oncology database. Postoperative radiographs were assessed for: 1) combined partial graft resorption and ingrowth at the graft site; 2) complete graft resorption with complete incorporation of new bone into the defect. After chronologically grouping radiographs, the volume of graft material used to fill bony defects, radiographic evidence of complications, and patterns of resorption were recorded. Results Partial resorption of graft material/partial ingrowth of new bone was seen in 21 patients at 2.5 months postoperatively. Complete resorption of graft with complete new bone incorporation at the graft site was seen in 94% of cases (15 of 16) by 10 months after surgery. Mean time to complete incorporation of new bone was 6.7 months. Time to resorption of the graft with new bone ingrowth was found to be related to the volume of graft used with smaller volumes showing earlier resorption. For all cases demonstrating resorption (21 of 21), the pattern observed was peripheral to central. Five patients developed complications, including tumour recurrence, cyst formation, and graft site infection. Conclusion Our study suggests a characteristic time and volume related radiographic pattern of resorption and new bone ingrowth with the CaSO4/CaPO4 synthetic graft. Findings that deviate from this pattern may represent complication and warrant additional follow-up.


2000 ◽  
Vol 04 (02) ◽  
pp. 129-134 ◽  
Author(s):  
M. W. Lawless ◽  
R. T. Laughlin ◽  
J. M. Kerpsack ◽  
D. Pisut

Purpose: To determine the rate of antibiotic elution from tobramycin-impregnated ProOsteon (Interpore) and Collagraft (Zimmer). Methods: Five samples of Collagraft and ProOsteon were impregnated with a solution containing 1.2 g of tobramycin and 10 ml of sterile water. The samples were then allowed to dry overnight. These samples were stored at 37°C in separate test tubes containing phosphate buffered saline (PBS). The solution in each test tube was removed with a pipette at hours 3, 6, 9 and 12 and days 1, 2, 3, 5, 7, 9, 11 and 13. The PBS was then replaced. The pipetted solution was sent for laboratory quantification and also used in a bioassay to determine antibiotic level. To serve as a control, two additional samples of each bone graft that were not impregnated with antibiotic were placed in separate test tubes and subjected to the same protocol. Results: The antibiotic elution rate for both ProOsteon and Collagraft was high at 3 hours [5362 and 4875 μg/ml on day 3 (3.1 μg/ml) for the Collagraft and day 7 (3.7 μg/ml) for the ProOsteon]. Effective intravenous tobramycin level is considered to be 4–6 μg/ml. Conclusion: Bone graft substitute can be used as a delivery vehicle for tobramycin. In addition, antibiotic-impregnated synthetic bone graft may potentially fill a dead space or cavitary defect without the need for large autologous grafts and does not require later removal.


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