Lumbar Spinal StenosisNCT06075355
Can Minimally Invasive Decompression Surgery Restore Sagittal Balance in a Patient Population With Sagittal Imbalance and Lumbar Spinal Stenosis
An observational study of Lumbar Spinal Stenosis, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
From adulthood onwards, the aging process manifests itself in the spine through loss of disc height and kyphotic deformity. As the general population ages, the prevalence of lumbar degenerative diseases and sagittal imbalance increases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Spinal Stenosis
- How many people
- 116 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jun 2024to 31 Mar 2025
- 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
- Adult, Older adult
Study population: patient suffering from lumbar stenosis, adressed for minimally invasive lumbar decompression between january, 1st 2014 and january 31st, 2020
Who may be able to join
- Patient age ≥ 18 years
- French-speaking patients
- Patients undergoing minimally invasive lumbar decompression with or without one- or two-level arthrodesis
- Patients with preoperative sagittal imbalance measured on EOS images (sagittal vertebral axis > 50 mm)
Who cannot join
- Patients under guardianship or curatorship
- Patient deprived of liberty
- Patient under court protection
- Patient objecting to the use of his or her data for this study
- Revision surgery
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Paris Saint Joseph
Paris, 75014
Hélène BEAUSSIER, pharmaD, PhD, +33144127038, hbeaussier@ghpsj.fr
Juliette COURTIADE MAHLER, phD, +33144127963, jcourtiade@ghpsj.fr
About this study
Official title: Sagittal : Can Minimally Invasive Decompression Surgery Restore Sagittal Balance in a Patient Population With Sagittal Imbalance and Lumbar Spinal Stenosis
From adulthood onwards, the aging process manifests itself in the spine through loss of disc height and kyphotic deformity. As the general population ages, the prevalence of lumbar degenerative diseases and sagittal imbalance increases. Sagittal balance is a physiological alignment resulting from the effective muscular and ligamentary forces that place patients' heads harmoniously in line with their pelvis. Roussouly first classified this alignment by differentiating four types of balance in an asymptomatic population. He established a link between the varieties of sagittal balance of the spine, the sacral slope and the position of the pelvis in space. He went on to explain sagittal imbalance in the aging population suffering from degenerative diseases.
One of the most common lumbar degenerative diseases is lumbar spinal canal stenosis. Stenosis of the lumbar spinal canal is frequently associated with sagittal imbalance of the spine. Lumbar canal stenosis causes lumbar pain, leg pain, neurogenic intermittent claudication and bladder and rectal disorders. The severity of clinical symptoms increases linearly with progressive sagittal imbalance [8]. We represent the sagittal imbalance of the spine by a positive sagittal vertical axis (SVA) presented by patients to reduce the pressure exerted by the yellow ligament, which is hypertrophied in degenerative disease . Many have shown that this forward-flexing posture can be improved by simple decompression, and that this deformity corresponds to an analgesic position and not to a structural deformity. Little is known about the factors that influence alignment after lumbar canal decompression and short segment fusion.
This study therefore aims to elucidate some of the clinical and radiological factors likely to affect postoperative sagittal balance in patients undergoing simple minimally invasive decompression surgery and short segment fusion (1 or 2 levels).
- Conditions
- Lumbar Spinal Stenosis
- Keywords
- lumbar stenosis, sagittal imbalance, minimally invasive decompression surgery
- Medical subject headings
- Spinal Stenosis, Constriction, Pathologic
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of sagittal balance after minimally invasive decompression surgery
Sagittal Vertebral axis mesurement before and after surgery
Measured: 3 months
Secondary outcomes (6)
barrey Ratio
mesurement of the Barrey Ratio before and after surgery
Measured: 3 months
lumbar lordosis
mesurement of the lumbar lordosis before and after surgery
Measured: 3 months
pelvic incidence
mesurement of the pelvic incidence before and after surgery
Measured: 3 months
pelvic version
mesurement of the pelvic version before and after surgery
Measured: 3 months
sacred gradient
mesurement of the sacred version before and after surgery
Measured: 3 months
thoracic kyphosis
mesurement of the thoracic kyphosis before and after surgery
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start30 Jun 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal StenosisStudies 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
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06075355
- Sponsor's protocol ID
- Sagittal
- Status last verified
- Mar 2024
- First submitted
- 4 Oct 2023
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sagittal : Can Minimally Invasive Decompression Surgery Restore Sagittal Balance in a Patient Population With Sagittal Imbalance and Lumbar Spinal Stenosis
- ClinicalTrials.gov ID
- NCT06075355
- Acronym / sponsor ID
- Sagittal
- Conditions
- Lumbar Spinal Stenosis
- Keywords
- lumbar stenosis, sagittal imbalance, minimally invasive decompression surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 30 Jun 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 10 Oct 2023 (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.
From adulthood onwards, the aging process manifests itself in the spine through loss of disc height and kyphotic deformity. As the general population ages, the prevalence of lumbar degenerative diseases and sagittal imbalance increases. Sagittal balance is a physiological alignment resulting from the effective muscular and ligamentary forces that place patients' heads harmoniously in line with their pelvis. Roussouly first classified this alignment by differentiating four types of balance in an asymptomatic population. He established a link between the varieties of sagittal balance of the spine, the sacral slope and the position of the pelvis in space. He went on to explain sagittal imbalance in the aging population suffering from degenerative diseases.
One of the most common lumbar degenerative diseases is lumbar spinal canal stenosis. Stenosis of the lumbar spinal canal is frequently associated with sagittal imbalance of the spine. Lumbar canal stenosis causes lumbar pain, leg pain, neurogenic intermittent claudication and bladder and rectal disorders. The severity of clinical symptoms increases linearly with progressive sagittal imbalance [8]. We represent the sagittal imbalance of the spine by a positive sagittal vertical axis (SVA) presented by patients to reduce the pressure exerted by the yellow ligament, which is hypertrophied in degenerative disease . Many have shown that this forward-flexing posture can be improved by simple decompression, and that this deformity corresponds to an analgesic position and not to a structural deformity. Little is known about the factors that influence alignment after lumbar canal decompression and short segment fusion.
This study therefore aims to elucidate some of the clinical and radiological factors likely to affect postoperative sagittal balance in patients undergoing simple minimally invasive decompression surgery and short segment fusion (1 or 2 levels).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patient suffering from lumbar stenosis, adressed for minimally invasive lumbar decompression between january, 1st 2014 and january 31st, 2020
Key inclusion criteria (4 listed)
- Patient age ≥ 18 years
- French-speaking patients
- Patients undergoing minimally invasive lumbar decompression with or without one- or two-level arthrodesis
- Patients with preoperative sagittal imbalance measured on EOS images (sagittal vertebral axis > 50 mm)
Key exclusion criteria (5 listed)
- Patients under guardianship or curatorship
- Patient deprived of liberty
- Patient under court protection
- Patient objecting to the use of his or her data for this study
- Revision surgery
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
Evolution of sagittal balance after minimally invasive decompression surgery
Time frame: 3 months
Sagittal Vertebral axis mesurement before and after surgery
6 secondary outcomes
barrey Ratio
Time frame: 3 months
lumbar lordosis
Time frame: 3 months
pelvic incidence
Time frame: 3 months
pelvic version
Time frame: 3 months
sacred gradient
Time frame: 3 months
thoracic kyphosis
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
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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.
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 Lumbar Spinal Stenosis, 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 5 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 12 Mar 2024. 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?
Contact Pierre Emmanuel Moreau, MD (+33144127038, pemoreau@ghpsj.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of sagittal balance after minimally invasive decompression surgery (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2024.