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Recruiting NCT07017985

Prevalence of Diabetes in Patients Who Are Candidates for Spine Surgery

Observational Spine Disease

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 →

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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗