An observational study in Spinal Deformity, sponsored by Fondation Hôpital Saint-Joseph. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-07.
Sponsored by Fondation Hôpital Saint-Joseph · Observational
Spinal deformity in adults is one of the most frequently treated pathologies in spinal surgery. Their surgical treatment remains a challenge. In particular, the choice of the borderline vertebrae for thoracolumbar fusion correction remains controversial, including the choice between an instrumented last vertebra at L5 and an arthrodesis extending to the pelvis. Studies and meta-analyses show that an ilio-sacral socket provides better correction of pelvic parameters and avoids the development of distal junctional syndrome. On the other hand, there is more proximal junctional syndrome in patients fixed to the sacrum, and the sacral socket exposes patients to the risk of pseudarthrosis of the L5-S1 level and failure of the fixation hardware. Moreover, although this factor is not described in the studies, it would seem that an ilio-sacral socket is more stiffening. Overall, no study has shown a statistically significant difference in clinical scores between patients whose last instrumented vertebra is L5 and those with pelvic fixation.
One of the theoretical risks of an extended fixation with a proximal thoracic grasp is to observe a premature disc degeneration of the L5-S1 disc since it would be subjected to more stress. This degeneration could be the cause of distal junctional syndrome and lumbo-radiculalgia due to inflammatory disc disease and disco-radicular impingement. However, to Investigator's knowledge, no clinical study has yet investigated the medium- and long-term fate of the L5-S1 disc in patients with extended fusion correction of a thoracic vertebra to L5.
Investigator's team has sometimes favored a final instrumented vertebra at L5 when possible, i.e., when the L5-S1 disc was considered to be minimally or not degenerative and when its horizontality could be obtained after correction of the underlying curvature. Investigators therefore have a cohort of patients who have undergone this technique. The usual follow-up of these patients includes a consultation appointment every 2 to 5 years and a control MRI at a distance of more than 5 years: investigators thus have a control MRI and the clinical score of the patients.
Investigator's objective is to determine whether there is degeneration of the L5-S1 disc, using MRI imaging data, which has never been published to investigator's knowledge.
980 studies on the registry are indexed under Congenital Abnormalities; 177 are open to participants now.
This study's enrollment of 17 is below the median of 153 across 446 observational studies indexed under Congenital Abnormalities.
Browse Congenital Abnormalities studies →Fondation Hôpital Saint-Joseph is the lead sponsor of 335 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient whose age is ≥ 18 years, with spinal fixation extended from the thorax to L5, performed between 2007 (15 years of recoil and beginning of systematic preoperative MRI) and 2017 (5 years of recoil minimum).
Exclusion Criteria:
Degeneration of the L5-S1 disc assessed by the Pffirman score
This outcome corresponds to the appearance of L5-S1 disc degradation according to the Pffirmann score between the first MRI performed as part of the preoperative workup in the 6 months prior to surgery and the 5-year follow-up MRI. The Pfirmann classification allows grading of disc degeneration at the lumbar level on T2-weighted sagittal or STIR sequences on MRI. Grade 1 corresponds to a healthy disc and is rarely observed in adults. Grade 5 corresponds to disc collapse.
Time frame: Year 5
Pelvic parameters
This outcome corresponds to the variation of pelvic parameters.
Time frame: Year 5
Onset of spondylolisthesis
This outcome corresponds to the appearance of a spondylolisthesis L5-S1.
Time frame: Year 5
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Fondation Hôpital Saint-Joseph