A Prospective, Randomized, Controlled Trial Comparing Radiographic and Clinical Outcomes between Stand-Alone Lateral Interbody Lumbar Fusion with either Silicate Calcium Phosphate or rh-BMP2

Pimenta, Luiz; Marchi, Luís; Oliveira, Leonardo; Coutinho, Etevaldo; Amaral, Rodrigo

doi:10.1055/s-0032-1333420

Cited by 87 publications

(48 citation statements)

References 51 publications

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“…The potential advantages of the LLIF technique include less invasive access, the preservation of stabilizing ligaments, restoration of intervertebral disc height with indirect decompression of the intervertebral foramina, and satisfactory fusion rates (5,9,13,14). Because of the additional stabilization afforded by the LLIF procedure, the senior surgeon of this present study was encouraged to explore the impact of less extensive posterior instrumentation with the idea that unilateral pedicle screw placement may result in less operative time, less blood loss, and lower costs without compromising clinical and radiographic outcomes.…”

Section: Discussionmentioning

confidence: 99%

Early clinical and radiological results of unilateral posterior pedicle instrumentation through a Wiltse approach with lateral lumbar interbody fusion

Kiely

Bogner

et al. 2017

J. Spine Surg.

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Background: To assess the clinical outcomes of 44 patients who underwent single-level lateral lumbar interbody fusion (LLIF) with unilateral pedicle screw instrumentation through a paramedian Wiltse approach.Methods: Demographic, comorbidity, clinical assessment, peri-operative, and complication data were assessed. Visual analog scale (VAS), Oswestry disability index (ODI), and short form-12 (SF-12) were used to assess clinical outcomes. Post-operative plain radiographs were assessed for subsidence, cage migration, and fusion.Results: Average age of patients at surgery was 60.8±10.6 years (range, 32-79 years), with 15 males and 29 females. Recombinant human bone morphogenic protein-2 (rhBMP-2) was used in 32 cases (73%) and 13 posterolateral fusions (30%). Average duration of surgery was 195.2±36.9 minutes (range: 111-295 minutes), with an estimated blood loss of 159.3±90.8 cc (range, 50-500 cc). There were no intra-operative complications.Average length of hospital stay was 4.2±2.5 days (range, 2-13 days). Four patients (9%) experienced neurological deficit, 2 of which resolved by 3-month follow-up and 2 of which improved but did not resolve by final follow-up at 11 and 16 months. There was significant improvement in VAS (P<0.001), ODI (P<0.001), and SF-12 physical component (P<0.001), but not for SF-12 mental component (P=0.053). Patients with minimum 6 months radiographic follow-up demonstrated successful fusion in 90% of cases (35/39), with 2 cases of grade 1 (5%) subsidence of the adjacent cranial vertebra, and no cases higher than grade 0 subsidence of the adjacent caudal vertebra.Conclusions: Unilateral pedicle screw instrumentation following LLIF was associated with significant improvement in clinical outcomes and favorable radiographic outcomes.

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Section: Discussionmentioning

confidence: 99%

Early clinical and radiological results of unilateral posterior pedicle instrumentation through a Wiltse approach with lateral lumbar interbody fusion

Kiely

Bogner

et al. 2017

J. Spine Surg.

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“…Ruetten et al [30] reported a mean VAS back of 4 (out of 100) and a VAS leg of 14 (out of 100) on postoperative day 1, stating that no post operative pain medication was required in their 463 patient series. Marchi et al [35] reported mean VAS back of 45 and VAS leg of 31 one week following surgery, while Pimenta et al [40] reported a combined VAS Back/ Leg value of 50 at the same time point. Virtually all of the data gathered involved application of the XLIF (NuVasive, San Diego, California, United States) system; there is at this point limited data on other systems.…”

Section: Dlif/xlifmentioning

confidence: 99%

“…Marchi et al [35] 2012 XLIF PCS Spondylolisthesis 52 -Sharma et al [36] 2011 XLIF RCS Spondylosis ± listhesis, scoliosis 43 -Pimenta et al [25] 2011 XLIF PCS DDD 36 -Ahmadian et al [37] 2013 XLIF RCS L4/L5 spondylolisthesis 31 -Caputo et al [38] 2012 XLIF PCS Scoliosis 30 -Malham et al [39] 2012 XLIF PCS DDD, spondylolisthesis, scoliosis 30 - 4 Pimenta et al [40] 2013 XLIF RCT L4/L5 DDD 30 -Elowitz et al [41] 2011 XLIF PCS LSS 25 -Oliveira et al [42] [27] ----28% 24% --Smith et al [28] 112 ± 31 173 ± 31 90 ± 74 311 ± 370 3% 6% 1.7 ± 1.3 3.6 ± 0.9 Rodgers et al [12] --1.4 g Hb 2.7 g Hb --1.3 5.3 Huang et al [29] 176 ± 8 202 ± 15 572 ± 93 970 ± 209 --11.6 ± 1.3 12.5 ± 1.3 Case series Rodgers et al [13] --1.38 g Hb -1% -1.2 -Ruetten et al [30] …”

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confidence: 99%

“…-0 1 -0% ---Lykissas et al [31] 295 ± 180 ---135% ---Grimm et al [32] 122 -181 -20% -3.0 -Tohmeh et al [33] ----48% ---Berjano et al [34] ----16% ---Lee et al [26] 52 ± 19 -0 [35] 73 ± 31 -< 50 -29% ---Sharma et al [36] ----70% ---Pimenta et al [25] 130 ---28% -1.4 -Ahmadian et al [37] --94 ---3.5 -Caputo et al [38] ----2 ---Malham et al [39] 84 -70 -20% ---Pimenta et al [40] 69 ± 11 -< 50 -13% ---Elowitz et al [41] ----20% 3 ---Oliveira et al [42] cutive, odd/even patient order). In Table 6 [45] polled patients on postoperative day 2, finding a VAS back of 2.2 ± 0.6 in MIS patients and 4.3 ± 0.5, a statistically significant difference (P < 0.05).…”

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confidence: 99%

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Perioperative outcomes in minimally invasive lumbar spine surgery: A systematic review

Skovrlj¹

2015

WJO

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AIM:To compare minimally invasive (MIS) and open techniques for MIS lumbar laminectomy, direct lateral and transforaminal lumbar interbody fusion (TLIF) surgeries with respect to length of surgery, estimated blood loss (EBL), neurologic complications, perioperative transfusion, postoperative pain, postoperative narcotic use, and length of stay (LOS). METHODS:A systematic review of previously published studies accessible through PubMed was performed. Only articles in English journals or published with English language translations were included. Level of evidence of the selected articles was assessed. Statistical data was calculated with analysis of variance with P < 0.05 considered statistically significant. RESULTS:

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“…Silicate substituted calcium phosphate (Si-CaP) in lumbar spine and cervical spine Level I and level II studies evaluating the efficacy of Si-CaP versus autologous bone grafts are currently lacking, though two level I studies 100,101 comparing SiCaP with rhBMP were identified. Level IV retrospective studies by Jenis et al 102 and Nagineni et al 103 reported fusion rates from 76.5% to 90% with the use of Si-Cap in cervical and lumbar fusion procedures.…”

mentioning

confidence: 99%

Bone substitutes and expanders in Spine Surgery: A review of their fusion efficacies

et al. 2016

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Study Design A narrative review of literature. ObjectiveThis manuscript intends to provide a review of clinically relevant bone substitutes and bone expanders for spinal surgery in terms of efficacy and associated clinical outcomes, as reported in contemporary spine literature. Summary of Background DataEver since the introduction of allograft as a substitute for autologous bone in spinal surgery, a sea of literature has surfaced, evaluating both established and newly emerging fusion alternatives. An understanding of the available fusion options and an organized evidence-based approach to their use in spine surgery is essential for achieving optimal results. MethodsA Medline search of English language literature published through March 2016 discussing bone graft substitutes and fusion extenders was performed. All clinical studies reporting radiological and/or patient outcomes following the use of bone substitutes were reviewed under the broad categories of Allografts, Demineralized Bone Matrices (DBM), Ceramics, Bone Morphogenic proteins (BMPs), Autologous growth factors (AGFs), Stem cell products and Synthetic Peptides. These were further grouped depending on their application in lumbar and cervical spine surgeries, deformity correction or other miscellaneous procedures viz. trauma, infection or tumors; wherever data was forthcoming. Studies in animal populations and experimental in vitro studies were excluded. Primary endpoints were radiological fusion rates and successful clinical outcomes. ResultsA total of 181 clinical studies were found suitable to be included in the review. More than a third of the published articles (62 studies, 34.25%) focused on BMP. Ceramics (40 studies) and Allografts (39 studies) were the other two highly published groups of bone substitutes. Highest radiographic fusion rates were observed with BMPs, followed by allograft and DBM. There were no significant differences in the reported clinical outcomes across all classes of bone substitutes. ConclusionsThere is a clear publication bias in the literature, mostly favoring BMP. Based on the available data, BMP is however associated with the highest radiographic fusion rate. Allograft is also very well corroborated in the literature. The use of DBM as a bone expander to augment autograft is supported, especially in the lumbar spine. Ceramics are also utilized as bone graft extenders and results are generally supportive, although limited. The use of autologous growth factors is not substantiated at this time. Cell matrix or stem cell-based products and the synthetic peptides have inadequate data. More comparative studies are needed to evaluate the efficacy of bone graft substitutes overall.keywords: bone substitutes, allografts, demineralized bone matrix (dbm), spine fusion, ceramics, β tricalcium phosphate (β-tcp), hydroxyapatite, rhbmp-2, osteogenic protein-1 (op-1), autologous growth factors, i-factor, synthetic peptides volume 10 article 33

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A Prospective, Randomized, Controlled Trial Comparing Radiographic and Clinical Outcomes between Stand-Alone Lateral Interbody Lumbar Fusion with either Silicate Calcium Phosphate or rh-BMP2

Cited by 87 publications

References 51 publications

Early clinical and radiological results of unilateral posterior pedicle instrumentation through a Wiltse approach with lateral lumbar interbody fusion

Early clinical and radiological results of unilateral posterior pedicle instrumentation through a Wiltse approach with lateral lumbar interbody fusion

Perioperative outcomes in minimally invasive lumbar spine surgery: A systematic review

Bone substitutes and expanders in Spine Surgery: A review of their fusion efficacies

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