A New Stand-Alone Anterior Lumbar Interbody Fusion Device: Biomechanical Comparison with Established Fixation Techniques

Cain, Christopher M.; Schleicher, Philip; Gerlach, Rene; Pflugmacher, Robert; Scholz, Matti; Kandziora, Frank

doi:10.1097/01.brs.0000187897.25889.54

Cited by 71 publications

(44 citation statements)

References 14 publications

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“…These devices now offer stability comparable to that conferred by posterior fixation, without need of posterior access. 4,25 As a cautionary note, however, we describe in this report a rare instance of L-4 vertebral body fracture following use of a novel standalone interbody fusion device for L3-4 ALIF.…”

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confidence: 99%

Fracture of the L-4 vertebral body after use of a stand-alone interbody fusion device in degenerative spondylolisthesis for anterior L3–4 fixation

Y¹,

Jang

Lee³

et al. 2014

SPI

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Many studies attest to the excellent results achieved using anterior lumbar interbody fusion (ALIF) for degenerative spondylolisthesis. The purpose of this report is to document a rare instance of L-4 vertebral body fracture following use of a stand-alone interbody fusion device for L3–4 ALIF. The patient, a 55-year-old man, had suffered intractable pain of the back, right buttock, and left leg for several weeks. Initial radiographs showed Grade I degenerative spondylolisthesis, with instability in the sagittal plane (upon 15° rotation) and stenosis of central and both lateral recesses at the L3–4 level. Anterior lumbar interbody fusion of the affected vertebrae was subsequently conducted using a stand-alone cage/plate system. Postoperatively, the severity of spondylolisthesis diminished, with resolution of symptoms. However, the patient returned 2 months later with both leg weakness and back pain. Plain radiographs and CT indicated device failure due to anterior fracture of the L-4 vertebral body, and the spondylolisthesis had recurred. At this point, bilateral facetectomies were performed, with reduction/fixation of L3–4 by pedicle screws. Again, degenerative spondylolisthesis improved postsurgically and symptoms eased, with eventual healing of the vertebral body fracture. This report documents a rare instance of L-4 vertebral body fracture following use of a stand-alone device for ALIF at L3–4, likely as a consequence of angular instability in degenerative spondylolisthesis. Under such conditions, additional pedicle screw fixation is advised.

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confidence: 99%

Fracture of the L-4 vertebral body after use of a stand-alone interbody fusion device in degenerative spondylolisthesis for anterior L3–4 fixation

Y¹,

Jang

Lee³

et al. 2014

SPI

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“…This difference was not found when comparing the test device and posterior instrumentation [4]. A comparison of the STALIF to posterior instrumentation techniques could add supporting information to these hypotheses.…”

Section: Discussionmentioning

confidence: 87%

“…In [4], the test device was compared to standard anteroposterior constructs. This study revealed a higher ability of the test device to withstand axial torque compared to standard pedicle screw instrumentation.…”

Section: Discussionmentioning

confidence: 99%

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Biomechanical comparison of two different concepts for stand alone anterior lumbar interbody fusion

Schleicher

Gerlach

B³

et al. 2008

Eur Spine J

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Segmental instability in degenerative disc disease is often treated with anterior lumbar interbody fusion (ALIF). Current techniques require an additional posterior approach to achieve sufficient stability. The test device is an implant which consists of a PEEK-body and an integrated anterior titanium plate hosting four diverging locking screws. The test device avoids posterior fixation by enhancing stability via the locking screws. The test device was compared to an already established stand alone interbody implant in a human cadaveric three-dimensional stiffness test. In the biomechanical test, the L4/5 motion segment of 16 human cadaveric lumbar spines were isolated and divided into two test groups. Tests were performed in flexion, extension, right and left lateral bending, right and left axial rotation. Each specimen was tested in native state first, then a discectomy was performed and either of the test implants was applied. Finite element analysis (FE) was also performed to investigate load and stress distribution within the implant in several loading conditions. The FE models simulated two load cases. These were flexion and extension with a moment of 5 Nm. The biomechanical testing revealed a greater stiffness in lateral bending for the SynFix-LR TM compared to the established implant. Both implants showed a significantly higher stiffness in all loading directions compared to the native segment. In flexion loading, the PEEK component takes on most of the load, whereas the majority of the extension load is put on the screws and the screw-plate junction. Clinical investigation of the test device seems reasonable based on the good results reported here.

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“…Recently, ALIF using stand-alone interbody cage has been introduced and clinically used, which it can make the surgery to be performed only anterior access 2,3,9,15,26,28) . However, though there have been several biomechanical studies to assess stabilization property of stand-alone device, clinical studies to evaluate clinical and radiological results of standalone ALIF surgeries have been rarely reported.…”

Section: Introductionmentioning

confidence: 99%

Anterior Lumbar Interbody Fusion with Stand-Alone Interbody Cage in Treatment of Lumbar Intervertebral Foraminal Stenosis : Comparative Study of Two Different Types of Cages

Cho

Ryu

Park

2010

J Korean Neurosurg Soc

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Objective : This retrospective study was performed to evaluate the clinical and radiological results of anterior lumbar interbody fusion (ALIF) using two different stand-alone cages in the treatment of lumbar intervertebral foraminal stenosis (IFS). Methods : A total of 28 patients who underwent ALIF at L5-S1 using stand-alone cage were studied [Stabilis ® (Stryker, Kalamazoo, MI, USA); 13, SynFix-LR ® (Synthes Bettlach, Switzerland); 15]. Mean follow-up period was 27.3 ± 4.9 months. Visual analogue pain scale (VAS) and Oswestry disability index (ODI) were assessed. Radiologically, the change of disc height, intervertebral foraminal (IVF) height and width at the operated segment were measured, and fusion status was defined. Results : Final mean VAS (back and leg) and ODI scores were significantly decreased from preoperative values (5.6 ± 2.3 � 2.3 ± 2.2, 6.3 ± 3.2 �1.6 ± 1.6, and 53.7 ± 18.6 � 28.3 ± 13.1, respectively), which were not different between the two devices groups. In Stabilis ® group, postoperative immediately increased disc and IVF heights (10.09 ± 4.15 mm � 14.99 ± 1.73 mm, 13.00 ± 2.44 mm � 16.28 ± 2.23 mm, respectively) were gradually decreased, and finally returned to preoperative value (11.29 ± 1.67 mm, 13.59 ± 2.01 mm, respectively). In SynFix-LR ® group, immediately increased disc and IVF heights (9.60 ± 2.82 mm � 15.61 ± 0.62 mm, 14.01 ± 2.53 mm � 21.27 ± 1.93 mm, respectively) were maintained until the last follow up (13.72 ± 1.21 mm, 17.87 ± 2.02 mm, respectively). The changes of IVF width of each group was minimal pre-and postoperatively. Solid arthrodesis was observed in 11 patients in Stabilis group (11/13, 84.6%) and 13 in SynFix-LR ® group (13/15, 86.7%). Conclusion : ALIF using stand-alone cage could assure good clinical results in the treatment of symptomatic lumbar IFS in the mid-term follow up. A degree of subsidence at the operated segment was different depending on the device type, which was higher in Stabilis ® group.

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A New Stand-Alone Anterior Lumbar Interbody Fusion Device: Biomechanical Comparison with Established Fixation Techniques

Abstract: The Test-device alone provided similar and the Test-device and TS higher stability than the pedicle screw constructs evaluated. These results support progression to clinical trials using the Test-device as a stand-alone implant.

Cited by 71 publications

References 14 publications

Fracture of the L-4 vertebral body after use of a stand-alone interbody fusion device in degenerative spondylolisthesis for anterior L3–4 fixation

Fracture of the L-4 vertebral body after use of a stand-alone interbody fusion device in degenerative spondylolisthesis for anterior L3–4 fixation

Biomechanical comparison of two different concepts for stand alone anterior lumbar interbody fusion

Anterior Lumbar Interbody Fusion with Stand-Alone Interbody Cage in Treatment of Lumbar Intervertebral Foraminal Stenosis : Comparative Study of Two Different Types of Cages

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