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

ABSTRACT: 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.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.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.Clinical Trials NCT00810433.

SUBMITTER: Birkenmaier C

PROVIDER: S-EPMC2944216 | biostudies-literature | 2010 Sep

REPOSITORIES: biostudies-literature

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

Birkenmaier Christof C Suess Olaf O Pfeiffer Michael M Burger Ralf R Schmieder Kirsten K Wegener Bernd B

BMC musculoskeletal disorders 20100906

<h4>Background</h4>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 ...[more]

PMID: 20819219

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Project description:BackgroundMinimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) and oblique lateral interbody fusion (OLIF) are widely used in the treatment of lumbar degenerative diseases. In the present study, a meta-analysis was conducted to compare the clinical and radiographic efficacy of these two procedures.MethodsA systematic literature review was performed, and the quality of retrieved studies was evaluated with the Newcastle-Ottawa Scale (NOS). Clinical outcomes, including operation time, intraoperative blood loss, improvement in Visual Analogue Scale (VAS), improvement in Oswestry Disability Index (ODI), Japanese Orthopaedic Association Back Pain Evaluation Questionnaire (JOABPEQ) effectiveness rate and complications, in addition to radiographic outcomes, including restoration of disc height, disc angle, overall lumbar lordosis, fusion rate and subsidence, were extracted and input into a fixed or random effect model to compare the efficacy of MIS-TLIF and OLIF.ResultsSeven qualified studies were included. Clinically, OLIF resulted in less intraoperative blood loss and shorter operation time than MIS-TLIF. Improvement of VAS for leg pain was more obvious in the OLIF group (P < 0.0001), whereas improvement of VAS for back pain (P = 0.08) and ODI (P = 0.98) as well as JOABPEQ effectiveness rate (P = 0.18) were similar in the two groups. Radiographically, OLIF was more effective in restoring disc height (P = 0.01) and equivalent in improving the disc angle (P = 0.18) and lumbar lordosis (P = 0.48) compared with MIS-TLIF. The fusion rate (P = 0.11) was similar in both groups, while the subsidence was more severe in the MIS-TLIF group (P < 0.00001).ConclusionsThe above evidence suggests that OLIF is associated with a shorter operation time (with supplementary fixation in the prone position) and less intraoperative blood loss than MIS-TLIF and can lead to better leg pain alleviation, disc height restoration and subsidence resistance. No differences regarding back pain relief, functional recovery, complications, disc angle restoration, lumbar lordosis restoration and fusion rate were found. However, due to the limited number of studies, our results should be confirmed with high-level studies to fully compare the therapeutic efficacy of MIS-TLIF and OLIF.Trial registrationPROSPERO ID: CRD42020201903 .

Project description:BackgroundEndplate morphology is considered to be one of the influencing factors of cage subsidence after lumbar interbody fusion (LIF). Previous radiographic evaluations on the endplate mostly used sagittal X-ray or MRI. However, there are few studies on the CT evaluation of the endplate and intervertebral space (IVS), especially the evaluation of coronal morphology and its influence on subsidence and fusion after LIF. We aimed to measure and classify the shapes of the endplate and IVS using coronal CT imaging and evaluate the radiographic and clinical outcomes of different shapes of the endplate/IVS following oblique lateral lumbar interbody fusion (OLIF).MethodsA total of 137 patients (average age 59.1 years, including 75 males and 62 females) who underwent L4-5 OLIF combined with anterolateral fixation from June 2018 to June 2020 were included. The endplate concavity depth (ECD) was measured on the preoperative coronal CT image. According to ECD, the endplate was classified as flat (< 2 mm), shallow (2-4 mm), or deep (> 4 mm). The L4-5 IVS was further classified according to endplate type. The disc height (DH), DH changes, subsidence rate, fusion rate, and Oswestry Disability Index (ODI) in different endplate/IVS shapes were evaluated during 1-year follow up.ResultsThe ECD of L4 inferior endplate (IEP) was significantly deeper than that of L5 superior endplate (SEP) (4.2 ± 1.1 vs 1.6 ± 0.8, P < 0.01). Four types of L4-5 IVS were identified: shallow-shallow (16, 11.7%), shallow-flat (45, 32.9%), deep-shallow (32, 23.4%), and deep-flat (44, 32.1%). A total of 45 (32.9%) cases of cage subsidence were observed. Only one (6.3%) subsidence event occurred in the shallow-shallow group, which was significantly lower than in the other three groups (19 shallow-flat, 6 deep-shallow, and 19 deep-flat) (P < 0.05). Meanwhile, the shallow-shallow group had the highest fusion rate (15, 93.8%) and the highest rate of reach minimal clinically important difference (MCID) ODI among the four types. For a single endplate, the shape of L4 IEP is the main influencing factor of the final interbody fusion rate, and the shallow shape L4 IEP facilitates fusion ( OR = 2.85, p = 0.03). On the other hand, the flat shape L5 SEP was the main risk factor to cage subsidence (OR = 4.36, p < 0.01).ConclusionThe L4-5 IVS is asymmetrical on coronal CT view and tends to be fornix-above and flat-down. The shallow-shallow IVS has the lowest subsidence rate and best fusion result, which is possibly because it has a relatively good degree in matching either the upper or lower interface of the cage and endplates. These findings provide a basis for the further improvements in the design of OLIF cages.

Dataset Information

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

Publications

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

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