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

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.