scholarly journals An inception cohort study of patients in a military clinic treated for lower back pain with lumbar fusion and SIGNAFUSE® with a systematic review of the literature

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.

2016 ◽  
Vol 25 (4) ◽  
pp. 509-516 ◽  
Author(s):  
Zorica Buser ◽  
Darrel S. Brodke ◽  
Jim A. Youssef ◽  
Hans-Joerg Meisel ◽  
Sue Lynn Myhre ◽  
...  

The purpose of this review was to compare the efficacy and safety of synthetic bone graft substitutes versus autograft or allograft for the treatment of lumbar and cervical spinal degenerative diseases. Multiple major medical reference databases were searched for studies that evaluated spinal fusion using synthetic bone graft substitutes (either alone or with an autograft or allograft) compared with autograft and allograft. Randomized controlled trials (RCT) and cohort studies with more than 10 patients were included. Radiographic fusion, patient-reported outcomes, and functional outcomes were the primary outcomes of interest. The search yielded 214 citations with 27 studies that met the inclusion criteria. For the patients with lumbar spinal degenerative disease, data from 19 comparative studies were included: 3 RCTs, 12 prospective, and 4 retrospective studies. Hydroxyapatite (HA), HA+collagen, β-tricalcium phosphate (β-TCP), calcium sulfate, or polymethylmethacrylate (PMMA) were used. Overall, there were no differences between the treatment groups in terms of fusion, functional outcomes, or complications, except in 1 study that found higher rates of HA graft absorption. For the patients with cervical degenerative conditions, data from 8 comparative studies were included: 4 RCTs and 4 cohort studies (1 prospective and 3 retrospective studies). Synthetic grafts included HA, β-TCP/HA, PMMA, and biocompatible osteoconductive polymer (BOP). The PMMA and BOP grafts led to lower fusion rates, and PMMA, HA, and BOP had greater risks of graft fragmentation, settling, and instrumentation problems compared with iliac crest bone graft. The overall quality of evidence evaluating the potential use and superiority of the synthetic biological materials for lumbar and cervical fusion in this systematic review was low or insufficient, largely due to the high potential for bias and small sample sizes. Thus, definitive conclusions or recommendations regarding the use of these synthetic materials should be made cautiously and within the context of the limitations of the evidence.


2005 ◽  
Vol 16 (5) ◽  
pp. 467-475 ◽  
Author(s):  
K. A. Hing ◽  
B. Annaz ◽  
S. Saeed ◽  
P. A. Revell ◽  
T. Buckland

Cells ◽  
2020 ◽  
Vol 9 (10) ◽  
pp. 2250
Author(s):  
Kyoung-Tae Kim ◽  
Kwang Gi Kim ◽  
Un Yong Choi ◽  
Sang Heon Lim ◽  
Young Jae Kim ◽  
...  

The rates of pseudarthrosis remain high despite recent advances in bone graft substitutes for spinal fusion surgery. The aim of this single center, non-randomized, open-label clinical trial was to determine the feasibility of combined use of stromal vascular fraction (SVF) and β-tricalcium phosphate (β-TCP) for patients who require posterior lumbar interbody fusion (PLIF) and pedicle screw fixation. Two polyetheretherketone (PEEK) cages were inserted into the intervertebral space following complete removal of the intervertebral disc. The PEEK cage (SVF group) on the right side of the patient was filled with β-TCP in combination with SVF, and the cage on the left side (control group) was filled with β-TCP alone. Fusion rate and cage subsidence were assessed by lumbar spine X-ray and CT at 6 and 12 months postoperatively. At the 6-month follow-up, 54.5% of the SVF group (right-sided cages) and 18.2% of the control group (left-sided cages) had radiologic evidence of bone fusion (p = 0.151). The 12-month fusion rate of the right-sided cages was 100%, while that of the left-sided cages was 91.6% (p = 0.755). Cage subsidence was not observed. Perioperative combined use of SVF with β-TCP is feasible and safe in patients who require spinal fusion surgery, and it has the potential to increase the early bone fusion rate following spinal fusion surgery.


2016 ◽  
Vol 95 ◽  
pp. 71-76 ◽  
Author(s):  
Panagiotis Kerezoudis ◽  
Lorenzo Rinaldo ◽  
Doniel Drazin ◽  
David Kallmes ◽  
William Krauss ◽  
...  

1994 ◽  
Vol 27 (5) ◽  
pp. 1037-1074 ◽  
Author(s):  
Peter D. Costantino ◽  
Craig D. Friedman

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