The European multicenter trial on the safety and efficacy of guided oblique lumbar interbody fusion (GO-LIF)

Christof Birkenmaier, Olaf Suess, Michael Pfeiffer, Ralf Burger, Kirsten Schmieder, Bernd Wegener, Christof Birkenmaier, Olaf Suess, Michael Pfeiffer, Ralf Burger, Kirsten Schmieder, Bernd Wegener

Abstract

Background: Because of the implant-related problems with pedicle screw-based spinal instrumentations, other types of fixation have been tried in spinal arthrodesis. One such technique is the direct trans-pedicular, trans-discal screw fixation, pioneered by Grob for spondylolisthesis. The newly developed GO-LIF procedure expands the scope of the Grob technique in several important ways and adds security by means of robotic-assisted navigation. This is the first clinical trial on the GO-LIF procedure and it will assess safety and efficacy.

Methods/design: Multicentric prospective study with n = 40 patients to undergo single level instrumented spinal arthrodesis of the lumbar or the lumbosacral spine, based on a diagnosis of: painful disc degeneration, painful erosive osteochondrosis, segmental instability, recurrent disc herniation, spinal canal stenosis or foraminal stenosis. The primary target criteria with regards to safety are: The number, severity and cause of intra- and perioperative complications. The number of significant penetrations of the cortical layer of the vertebral body by the implant as recognized on postoperative CT. The primary target parameters with regards to feasibility are: Performance of the procedure according to the preoperative plan. The planned follow-up is 12 months and the following scores will be evaluated as secondary target parameters with regards to clinical improvement: VAS back pain, VAS leg pain, Oswestry Disability Index, short form - 12 health questionnaire and the Swiss spinal stenosis questionnaire for patients with spinal claudication. The secondary parameters with regards to construct stability are visible fusion or lack thereof and signs of implant loosening, implant migration or pseudarthrosis on plain and functional radiographs.

Discussion: This trial will for the first time assess the safety and efficacy of guided oblique lumbar interbody fusion. There is no control group, but the results, the outcome and the rate of any complications will be analyzed on the background of the literature on instrumented spinal fusion. Despite its limitations, we expect that this study will serve as the key step in deciding whether a direct comparative trial with another fusion technique is warranted.

Trial registration: Clinical Trials NCT00810433.

Figures

Figure 1
Figure 1
The SpineAssist miniature robotic device is mounted on a radiolucent frame, which is attached to the patient. One of the modular arms (arm #2 in this case) is attached to the miniature robotic device and carries the drill sleeve at its end. A Steinmann pin is manually passed through the drill sleeve for demonstration purposes.
Figure 2
Figure 2
Shows the percutaneous drilling of a GO-LIF screw trajectory, using the drill sleeve. Lateral fluoroscopy is used to control for depth.
Figure 3
Figure 3
3-D-reconstruction of a percutaneous in-situ fixation of a grade 2 isthmic spondylolisthesis at L5/S1 using the GO-LIF technique.

References

    1. Fritzell P, Hagg O, Nordwall A. Complications in lumbar fusion surgery for chronic low back pain: comparison of three surgical techniques used in a prospective randomized study. A report from the Swedish Lumbar Spine Study Group. Eur Spine J. 2003;12(2):178–189.
    1. Jutte PC, Castelein RM. Complications of pedicle screws in lumbar and lumbosacral fusions in 105 consecutive primary operations. Eur Spine J. 2002;11(6):594–598. doi: 10.1007/s00586-002-0469-8.
    1. Minamide A, Akamaru T, Yoon ST, Tamaki T, Rhee JM, Hutton WC. Transdiscal L5-S1 screws for the fixation of isthmic spondylolisthesis: a biomechanical evaluation. J Spinal Disord Tech. 2003;16(2):144–149.
    1. Abdu WA, Wilber RG, Emery SE. Pedicular transvertebral screw fixation of the lumbosacral spine in spondylolisthesis. A new technique for stabilization. Spine. 1994;19(6):710–715. doi: 10.1097/00007632-199403001-00011.
    1. Chell J, Quinnell RC. Transvertebral pedicle fixation in severe grade spondylolisthesis. Report of three cases. J Neurosurg. 2001;95(1 Suppl):105–107.
    1. Smith JA, Deviren V, Berven S, Kleinstueck F, Bradford DS. Clinical outcome of trans-sacral interbody fusion after partial reduction for high-grade L5-S1 spondylolisthesis. Spine. 2001;26(20):2227–2234. doi: 10.1097/00007632-200110150-00014.
    1. Boachie-Adjei O, Do T, Rawlins BA. Partial lumbosacral kyphosis reduction, decompression, and posterior lumbosacral transfixation in high-grade isthmic spondylolisthesis: clinical and radiographic results in six patients. Spine. 2002;27(6):E161–168. doi: 10.1097/00007632-200203150-00019.
    1. Bartolozzi P, Sandri A, Cassini M, Ricci M. One-stage posterior decompression-stabilization and trans-sacral interbody fusion after partial reduction for severe L5-S1 spondylolisthesis. Spine. 2003;28(11):1135–1141. doi: 10.1097/00007632-200306010-00010.
    1. Bozkus H, Dickman CA. Transvertebral interbody cage and pedicle screw fixation for high-grade spondylolisthesis. Case report. J Neurosurg. 2004;100(1 Suppl Spine):62–65.
    1. Beringer WF, Mobasser JP, Karahalios D, Potts EA. Anterior transvertebral interbody cage with posterior transdiscal pedicle screw instrumentation for high-grade spondylolisthesis. Technical note. Neurosurg Focus. 2006;20(3):E7.
    1. Grob D, Humke T, Dvorak J. Direct pediculo-body fixation in cases of spondylolisthesis with advanced intervertebral disc degeneration. Eur Spine J. 1996;5(4):281–285. doi: 10.1007/BF00301335.
    1. Zagra A, Giudici F, Minoia L, Corriero AS, Zagra L. Long-term results of pediculo-body fixation and posterolateral fusion for lumbar spondylolisthesis. Eur Spine J. 2009;18(Suppl 1):151–155. doi: 10.1007/s00586-009-0997-6.
    1. Lieberman IH, Togawa D, Kayanja MM, Reinhardt MK, Friedlander A, Knoller N, Benzel EC. Bone-mounted miniature robotic guidance for pedicle screw and translaminar facet screw placement: Part I--Technical development and a test case result. Neurosurgery. 2006;59(3):641–650. doi: 10.1227/01.NEU.0000229055.00829.5B. discussion 641-650.
    1. Sukovich W, Brink-Danan S, Hardenbrook M. Miniature robotic guidance for pedicle screw placement in posterior spinal fusion: early clinical experience with the SpineAssist. Int J Med Robot. 2006;2(2):114–122.
    1. Pechlivanis I, Kiriyanthan G, Engelhardt M, Scholz M, Lucke S, Harders A, Schmieder K. Percutaneous placement of pedicle screws in the lumbar spine using a bone mounted miniature robotic system: first experiences and accuracy of screw placement. Spine (Phila Pa 1976) 2009;34(4):392–398.
    1. A Clinical Safety and Feasibility Study of the GO-LIF™ Approach.
    1. Gertzbein SD, Robbins SE. Accuracy of pedicular screw placement in vivo. Spine (Phila Pa 1976) 1990;15(1):11–14.
    1. Kosmopoulos V, Schizas C. Pedicle screw placement accuracy: a meta-analysis. Spine (Phila Pa 1976) 2007;32(3):E111–120.
    1. Hanley JA, Lippman-Hand A. If nothing goes wrong, is everything all right? Interpreting zero numerators. JAMA. 1983;249(13):1743–1745. doi: 10.1001/jama.249.13.1743.

Source: PubMed

Patrocinadores e Colaboradores

Condições médicas

Intervenções de drogas

3
Se inscrever