Prevalence of Diabetes in Patients Who Are Candidates for Spine Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Spine Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The purpose of the study is to assess, through systematic screening, the prevalence of diabetes or prediabetes in patients who are candidates for lumbar spine surgery.
Detailed description
This is a prospective, longitudinal, single-center, open-label observational study on a population of patients undergoing lumbar spine surgery.
This study does not alter patient management or the physician-patient relationship. Assessments take place during routinely scheduled consultations. Fasting blood glucose and glycated hemoglobin measurements are part of the standard preoperative assessment. Patient self-administered questionnaires are routinely completed for practice evaluation purposes and constitute a database for routine care.
Primary outcome measures
- Diabetes or prediabetes présence [Time frame: Day 1]
Secondary outcome measures (6)
- Low back pain [Time frame: Day 0]
- Low back pain [Time frame: Month 3]
- Radicular pain [Time frame: Day 0]
- Radicular pain [Time frame: Month 3]
- Functional Impact of the Disease [Time frame: Day 0]
- Functional Impact of the Disease [Time frame: Month 3]
Eligibility criteria
Inclusion criteria
- Adult patients,
- Patients who have been informed of the research and have not indicated their opposition to the use of their medical data,
- Patients who are candidates for their first lumbar spine surgery, whether instrumented or not
Exclusion criteria
- Non-instrumented percutaneous surgery (cementoplasty)
- Presence of spinal osteosynthesis equipment
- Surgery performed for an infectious or tumoral spinal condition
- Surgery via an anterior or lateral approach
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Hôpital Privé Jacques Cartier — Massy
Identifiers
NCT: NCT07017985 · 2023-06-007