Spine Disease
Conditions
Keywords
Spine surgery, Diabetes
Brief summary
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.
Interventions
None listed
Sponsors
GCS Ramsay Santé pour l'Enseignement et la Recherche
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes or prediabetes présence | Day 1 | Diabetes is defined as a blood glucose level of at least 1.26 g/L and a glycated hemoglobin level greater than or equal to 6.5%. Prediabetes is defined as a blood glucose level greater than 1.10 g/L and less than 1.26 g/L and a glycated hemoglobin level between 5.7% and 6.4%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Low back pain | Day 0 | Pain will be assessed by the patient on a visual analog scale from 0 to 10 (0 = no pain, 10 = maximum pain). |
| Radicular pain | Day 0 | Pain will be assessed by the patient on a visual analog scale from 0 to 10 (0 = no pain, 10 = maximum pain). |
| Functional Impact of the Disease | Day 0 | Functional Impact of the Disease is assessed with the Oswestry Disability Index (ODI) questionnaire. The ODI questionnaire consists of 10 questions regarding: pain, self-care, lifting, walking, sitting, standing, sleeping, sexual activity, social activity, and traveling. Each question offers six answers, with a score from 0 to 6, for the patient to select; a score of 0 corresponds to normal function, and a score of 6 to very impaired function. The resulting score is multiplied by 2 to obtain a percentage of disability, with 0% indicating no disability and 100% indicating the most significant disability. A score between 0 and 20% indicates minimal disability, a score between 21 and 40% indicates moderate disability, a score between 41 and 60% indicates severe disability, and a score above 61% indicates major disability. |
Countries
France
Contacts
Primary ContactRaphaël PIETTON, MD
Outcome results
None listed