Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05566119
Study type Observational
Source Groupe Hospitalier Paris Saint Joseph
Contact
Status Active, not recruiting
Phase
Start date August 12, 2022
Completion date December 31, 2023

See also
  Status Clinical Trial Phase
Completed NCT01220505 - Post Market Surveillance to Evaluate the Effectiveness the Polaris Deformity Spinal System
Terminated NCT00974623 - Bone Graft Materials Observational Registry N/A
Withdrawn NCT02058238 - ADDRESS - Adult Deformity Robotic vs. Freehand Surgery to Correct Spinal Deformity
Recruiting NCT05323448 - Efficacy of ARISTA-AH for Restoring Hemostasis Following Posterior Long-segment Spinal Fusion. N/A
Recruiting NCT05108948 - Research of Factors Determining the Improvement of Quality of Life at One Year of Adult Patients Treated for Spinal Deformity (COFTASD)
Completed NCT02950532 - Posterior Ligament Complex Assessment Without Magnetic Resonance Image in Thoracolumbar Fractures
Completed NCT01982045 - RCT of AttraX® Putty vs. Autograft in Instrumented Posterolateral Spinal Fusion N/A
Active, not recruiting NCT00738439 - Prospective, Multi-Center Adult Spinal Deformity Outcomes Database Registry
Completed NCT05579834 - Hemothorax Caused by Posterior Correction Surgery for Spinal Deformity
Completed NCT01608854 - Comparison of Antibiotic Protocols in Spine Patients With Postoperative Drains N/A
Recruiting NCT04899297 - Quality of Life in Parents of Adolescents With Spinal Deformities: Development of a New Questionnaire.
Completed NCT05239962 - A Reliability And Validity Study Of The Urdu Version Of Spine Functional Index.
Active, not recruiting NCT05001893 - Clinical Safety and Efficacy of S53P4 Bioactive Glass Putty in Spinal Fusion Surgery
Completed NCT01601054 - Supplemental Anterior Lumbar Interbody Fusion (ALIF) in Spinal Deformity N/A
Active, not recruiting NCT04670536 - The Degen Study: Post-market Clinical Follow-up on the PASS LP, PASS Degen and PASS Tulip Systems (PASS DEGEN)
Completed NCT03880292 - Spinal Deformity Intraoperative Monitoring. N/A
Recruiting NCT05856370 - The Ailliance Post-Market Clinical Study N/A
Recruiting NCT05146193 - AI-Powered Scoliosis Auto-Analysis System Multicenter Development and Validations
Active, not recruiting NCT04642456 - Balance Assessment Scale and Strength Measurement Protocol to Measure Functionality in Adults With Spinal Deformity N/A
Recruiting NCT04071665 - A Modified Lateral Lumbar Interbody Fusion VS. Transforaminal Lumbar Interbody Fusion for Adult Degenerative Scoliosis N/A