An observational study in Spine Disease, sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-12.
Sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche · Observational
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.
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.
174 studies on the registry are indexed under Spinal Diseases; 39 are open to participants now.
This study's planned enrollment of 500 is above the median of 117 across 64 observational studies indexed under Spinal Diseases.
Browse Spinal Diseases studies →GCS Ramsay Santé pour l'Enseignement et la Recherche is the lead sponsor of 207 studies on the registry; 99 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Population of patients who are candidates for lumbar spine surgery
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Diabetes or prediabetes présence
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%.
Time frame: Day 1
Low back pain
Pain will be assessed by the patient on a visual analog scale from 0 to 10 (0 = no pain, 10 = maximum pain).
Time frame: Day 0
Low back pain
Pain will be assessed by the patient on a visual analog scale from 0 to 10 (0 = no pain, 10 = maximum pain).
Time frame: Month 3
Radicular pain
Pain will be assessed by the patient on a visual analog scale from 0 to 10 (0 = no pain, 10 = maximum pain).
Time frame: Day 0
Radicular pain
Pain will be assessed by the patient on a visual analog scale from 0 to 10 (0 = no pain, 10 = maximum pain).
Time frame: Month 3
Functional Impact of the Disease
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.
Time frame: Day 0
Functional Impact of the Disease
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.
Time frame: Month 3
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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