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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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%. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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Population of patients who are candidates for lumbar spine surgery
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Raphaël PIETTON, MD | Contact | 01 60 13 60 60 | 33 | drraphaelpietton@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Privé Jacques Cartier | Recruiting | Massy | 91300 | France |
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| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| 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). | 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). | 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. | 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. | Month 3 |
| D009750 |
| Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |