Adult ScoliosisMOSCA-BNCT06815861
Perioperative Morbidity in Adult Scoliotic Surgery: Analysis of a Series From Brest (MOSCA-B)
An observational study of Adult Scoliosis and Spine Deformity, run by University Hospital, Brest at 1 site in France.
Trial summary
Scoliosis surgery is an invasive procedure essential for alleviating significant pain and improving the physical, psychological, aesthetic, professional, and social well-being of patients. However, it carries a considerable risk of perioperative complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Scoliosis, Spine Deformity, Neurosurgery
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2024to 31 Jan 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
- No healthy volunteers
- Adult, Older adult
Study population: Patient Who underwent scoliosis surgery between 2017 and 2024 at the Brest University Hospital
Who may be able to join
- Adult patient
- Patient affiliated with a social security system
- Who underwent scoliosis surgery between 2017 and 2024 at the Brest University Hospital
Who cannot join
- Patients under legal protection (guardianship, curatorship, etc.) Refusal to participate (expressed opposition) History of scoliosis surgery performed by another surgeon, regardless of the center or year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative Morbidity in Adult Scoliotic Surgery: Analysis of a Series From Brest
Scoliosis surgery is an invasive procedure essential for alleviating significant pain and improving the physical, psychological, aesthetic, professional, and social well-being of patients. However, it carries a considerable risk of perioperative complications. This retrospective study, conducted at Brest University Hospital since 2017, aims to analyze these complications to provide a detailed assessment, particularly since the introduction of the OARM (intraoperative CT navigation), with the goal of optimizing the safety and effectiveness of surgical interventions. The complications studied include neurological, infectious, mechanical, and cardiopulmonary complications, along with an additional "other" category for rare complications. The period analyzed extends from the immediate postoperative phase to the most recent follow-up consultation with the referring surgeon, which varies depending on the duration of follow-up for each patient.
- Conditions
- Adult Scoliosis, Spine Deformity, Neurosurgery
- Keywords
- adult scoliosis, spine deformity, neurosurgery, spine surgery
- Medical subject headings
- Scoliosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of postoperative complications
Number of complications (raw description), followed by univariate analysis to exclude confounding factors
Measured: at the time of inclusion
Secondary outcomes (1)
ODI SORE
ODI SCORE after the surgery
Measured: at the time of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start1 Dec 2024
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult ScoliosisStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06815861
- Sponsor's protocol ID
- 29BRC24.0313 - MOSCA-B
- Acronym
- MOSCA-B
- Status last verified
- Oct 2024
- First submitted
- 4 Feb 2025
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Morbidity in Adult Scoliotic Surgery: Analysis of a Series From Brest
- ClinicalTrials.gov ID
- NCT06815861
- Acronym / sponsor ID
- MOSCA-B / 29BRC24.0313 - MOSCA-B
- Conditions
- Adult Scoliosis, Spine Deformity, Neurosurgery
- Keywords
- adult scoliosis, spine deformity, neurosurgery, spine surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 10 Feb 2025 (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.
Scoliosis surgery is an invasive procedure essential for alleviating significant pain and improving the physical, psychological, aesthetic, professional, and social well-being of patients. However, it carries a considerable risk of perioperative complications. This retrospective study, conducted at Brest University Hospital since 2017, aims to analyze these complications to provide a detailed assessment, particularly since the introduction of the OARM (intraoperative CT navigation), with the goal of optimizing the safety and effectiveness of surgical interventions. The complications studied include neurological, infectious, mechanical, and cardiopulmonary complications, along with an additional "other" category for rare complications. The period analyzed extends from the immediate postoperative phase to the most recent follow-up consultation with the referring surgeon, which varies depending on the duration of follow-up for each patient.
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 Who underwent scoliosis surgery between 2017 and 2024 at the Brest University Hospital
Key inclusion criteria (3 listed)
- Adult patient
- Patient affiliated with a social security system
- Who underwent scoliosis surgery between 2017 and 2024 at the Brest University Hospital
Key exclusion criteria (1 listed)
- Patients under legal protection (guardianship, curatorship, etc.) Refusal to participate (expressed opposition) History of scoliosis surgery performed by another surgeon, regardless of the center or year
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
Number of postoperative complications
Time frame: at the time of inclusion
Number of complications (raw description), followed by univariate analysis to exclude confounding factors
1 secondary outcome
ODI SORE
Time frame: at the time of inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Adult Scoliosis and Spine Deformity, run by University Hospital, Brest 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 3 inclusion and 1 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 10 Feb 2025. 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?
Number of postoperative complications (time frame: at the time of inclusion). 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 10 Feb 2025.