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NCT Number: NCT07017985

Prevalence of Diabetes in Patients Who Are Candidates for Spine Surgery

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.

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Key information

Conditions

Spine Disease Bone Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Spinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Privé Jacques Cartier

Massy, 91300, France

Location status: Recruiting

Location contact

Raphaël PIETTON, MD

CONTACT

[email protected]

01 60 13 60 60 ext. 33

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Diabetes or prediabetes présence

    Time frame: 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 outcomes

  1. Low back pain

    Time frame: Day 0

    Pain will be assessed by the patient on a visual analog scale from 0 to 10 (0 = no pain, 10 = maximum pain).

  2. Low back pain

    Time frame: Month 3

    Pain will be assessed by the patient on a visual analog scale from 0 to 10 (0 = no pain, 10 = maximum pain).

  3. Radicular pain

    Time frame: Day 0

    Pain will be assessed by the patient on a visual analog scale from 0 to 10 (0 = no pain, 10 = maximum pain).

  4. Radicular pain

    Time frame: Month 3

    Pain will be assessed by the patient on a visual analog scale from 0 to 10 (0 = no pain, 10 = maximum pain).

  5. Functional Impact of the Disease

    Time frame: 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.

  6. Functional Impact of the Disease

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Raphaël PIETTON, MD

CONTACT

[email protected]

01 60 13 60 60 ext. 33

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Acronym: PREDIR

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 12, 2025
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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