L5-S1 Disc Fate in Thoracolumbar Arthrodesis Stopping at L5

NCT ID: NCT05566119

Last Updated: 2023-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-12

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spinal Deformity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patient whose age is ≥ 18 years
* 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)
* French speaking patient

Exclusion Criteria

* Neuromuscular scoliosis
* Indication of fixation for fracture of ankylosed spine (impossibility of analyzing the L5-S1 disc)
* Contraindication to the realization of an MRI except if the patient has been operated on for a complementary fixation of L5-S1 in the aftermath
* Patient under guardianship or curatorship (unless consent is provided for this purpose)
* Patient deprived of liberty
* Patients who oppose participation in the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fondation Hôpital Saint-Joseph

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gilles GUERIN, MD

Role: PRINCIPAL_INVESTIGATOR

Fondation Hôpital Saint-Joseph

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Groupe Hospitalier Paris Saint-Joseph

Paris, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

Yao YC, Kim HJ, Bannwarth M, Smith J, Bess S, Klineberg E, Ames CP, Shaffrey CI, Burton D, Gupta M, Mundis GM, Hostin R, Schwab F, Lafage V. Lowest Instrumented Vertebra Selection to S1 or Ilium Versus L4 or L5 in Adult Spinal Deformity: Factors for Consideration in 349 Patients With a Mean 46-Month Follow-Up. Global Spine J. 2023 May;13(4):932-939. doi: 10.1177/21925682211009178. Epub 2021 Apr 28.

Reference Type BACKGROUND
PMID: 33906457 (View on PubMed)

Taneichi H, Inami S, Moridaira H, Takeuchi D, Sorimachi T, Ueda H, Aoki H, Iimura T. Can we stop the long fusion at L5 for selected adult spinal deformity patients with less severe disability and less complex deformity? Clin Neurol Neurosurg. 2020 Jul;194:105917. doi: 10.1016/j.clineuro.2020.105917. Epub 2020 May 19.

Reference Type BACKGROUND
PMID: 32454414 (View on PubMed)

Sardar ZM, Ouellet JA, Fischer DJ, Skelly AC. Outcomes in adult scoliosis patients who undergo spinal fusion stopping at L5 compared with extension to the sacrum. Evid Based Spine Care J. 2013 Oct;4(2):96-104. doi: 10.1055/s-0033-1357360.

Reference Type BACKGROUND
PMID: 24436707 (View on PubMed)

Jia F, Wang G, Liu X, Li T, Sun J. Comparison of long fusion terminating at L5 versus the sacrum in treating adult spinal deformity: a meta-analysis. Eur Spine J. 2020 Jan;29(1):24-35. doi: 10.1007/s00586-019-06187-8. Epub 2019 Oct 17.

Reference Type BACKGROUND
PMID: 31624908 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

L5S1OTLSF

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Degenerative Scoliosis
NCT05105737 UNKNOWN