Spinal DeformityL5S1OTLSFNCT05566119
L5-S1 Disc Fate in Thoracolumbar Arthrodesis Stopping at L5
An observational study of Spinal Deformity, run by Fondation Hôpital Saint-Joseph at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Deformity
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- 12 Aug 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Spinal Deformity
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Year 5
Secondary outcomes (2)
Pelvic parameters
This outcome corresponds to the variation of pelvic parameters.
Measured: Year 5
Onset of spondylolisthesis
This outcome corresponds to the appearance of a spondylolisthesis L5-S1.
Measured: Year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start12 Aug 2022
- Primary completion12 Sep 2022
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Spinal DeformityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles GUERIN, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05566119
- Sponsor's protocol ID
- L5S1OTLSF
- Acronym
- L5S1OTLSF
- Status last verified
- Mar 2023
- First submitted
- 30 Sep 2022
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33906457Taneichi 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.
PubMed 32454414Sardar 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.
PubMed 24436707Jia 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.
PubMed 31624908
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- L5-S1 Disc Fate in Thoracolumbar Arthrodesis Stopping at L5
- ClinicalTrials.gov ID
- NCT05566119
- Acronym / sponsor ID
- L5S1OTLSF / L5S1OTLSF
- Conditions
- Spinal Deformity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 12 Aug 2022 (actual)
- Primary completion
- 12 Sep 2022 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 4 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Degeneration of the L5-S1 disc assessed by the Pffirman score
Time frame: Year 5
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.
2 secondary outcomes
Pelvic parameters
Time frame: Year 5
Onset of spondylolisthesis
Time frame: Year 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Background: PubMed 33906457Yao 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.
- Background: PubMed 32454414Taneichi 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.
- Background: PubMed 24436707Sardar 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.
- Background: PubMed 31624908Jia 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilles GUERIN, MD principal investigator
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Deformity, run by Fondation Hôpital Saint-Joseph at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degeneration of the L5-S1 disc assessed by the Pffirman score (time frame: Year 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05566119, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.