Perioperative Morbidity in Adult Scoliotic Surgery: Analysis of a Series From Brest (MOSCA-B) (MOSCA-B)

February 6, 2025 updated by: University Hospital, Brest

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France, 29609
        • CHU Brest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient Who underwent scoliosis surgery between 2017 and 2024 at the Brest University Hospital

Description

Inclusion Criteria:

  • Adult patient
  • Patient affiliated with a social security system
  • Who underwent scoliosis surgery between 2017 and 2024 at the Brest University Hospital

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of postoperative complications
Time Frame: at the time of inclusion
Number of complications (raw description), followed by univariate analysis to exclude confounding factors
at the time of inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ODI SORE
Time Frame: at the time of inclusion
ODI SCORE after the surgery
at the time of inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2024

Primary Completion (Estimated)

January 31, 2025

Study Completion (Estimated)

January 31, 2025

Study Registration Dates

First Submitted

February 4, 2025

First Submitted That Met QC Criteria

February 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 6, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29BRC24.0313 - MOSCA-B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected data that underlie results in a publication

IPD Sharing Time Frame

Data will be available beginning three years and ending fifteen years following the final study report completion

IPD Sharing Access Criteria

Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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