Prevalence of Diabetes in Patients Who Are Candidates for Spine Surgery

Recruiting

• Conditions: Spine Disease

• Registration Number: NCT07017985
• Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

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.

Study Timeline

• Study Start: 2024-03-28
• Status Verified: 2025-06
• Study First Submitted: 2025-06-04
• Study First Submitted QC: 2025-06-11
• Last Update Submitted: 2025-06-11
• Study First Posted: 2025-06-12
• Last Update Posted: 2025-06-12
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Radicular pain	Month 3	Pain will be assessed by the patient on a visual analog scale from 0 to 10 (0 = no pain, 10 = maximum pain).
Low back pain	Month 3	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	Month 3	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.

Trial Locations

Locations (1)

Hôpital Privé Jacques Cartier; 🇫🇷 Massy, France