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Clinical Trials in France / NCT05183542
Recruiting Not applicable

SPECT/CT Bone Scan Quantification Surgery

NCT05183542 · tracked via the Priya Life Science France tracker
Sponsor
Central Hospital, Nancy, France
Phase
Not applicable
Started
2022-04-29
Last updated
2026-06-25

Condition(s) studied

Pseudoarthrosis of Bone

Investigational drug(s) / intervention(s)

Bone scan

Bone scan: Persons to be operated on for lumbar arthrodesis by the neurosurgery team of the Nancy CHRU and respecting the eligibility criteria (including a score of neuropathique pain scale \< 4, see non-inclusion criteria), will be proposed to participate in the study neuropathic pain If they give their oral agreement to the neurosurgeon, a request for a bone scan will be sent to the nuclear medicine department of the Nancy-Brabois Hospital. The patients will fill pain scales before and after surgery (ODI and NS)

Study summary

The hypothesis of our study is that SPECT/CT bone scan fixation quantified by SUVMAX on a CZT solid state camera preoperatively would identify good responders to lumbar arthrodesis surgery.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Persons with back pain for at least 3 months (presumed to be due to degenerative disc disease or spondylolisthesis). * Persons who have received full information about the organisation of the research and have signed the informed consent and : * Age ≥ 18 years, having read and understood the information document. * Affiliated to a social security scheme. * Lumbar arthrodesis involving a maximum of 2 floors. * Standardized lumbar arthrodesis surgery performed by one of the three senior neurosurgeons of the neurosurgery department of the Nancy CHRU, using similar surgical techniques. Exclusion Criteria: * Low back pain of neuropathic origin. The Neuropathic Pain Scale 4 questionnaire is used to diagnose neuropathic pain (score is ≥ 4/10) * History of lumbar spine surgery * Presence of other pathologies responsible for lumbar pain (multistage discopathies, ankylosing spondylitis, spondylodiscitis, rheumatoid arthritis, vertebral compression, vertebral metastasis, narrow lumbar canal, scoliosis, spondylolisthesis by isthmic lysis) * Pregnant women or women of childbearing age without suitable contraception or nursing mothers. * Unstable medical condition and/or inability to remain immobile in supine position during recordings. * Known allergy to any component of the radiopharmaceutical (TECHNESCAN HDP). * Person referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code. * Persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care by virtue of Articles L. 3212-1 and L. 3213-1. * Persons of full age who are unable to express their opposition.

Primary outcome measure(s)

  • To determine if there is a correlation of SUV value and response to surgery with ODI — 24 months
    To determine whether SUVmax (Standard Uptake Value) measured at late time on bone scan, predicts a good response to lumbar arthrodesis surgery according to the Oswestry Disability Index (ODI) measured at 12 months after surgery

Trial sites (1)

FacilityCityRegionStatus
Nuclear Medicine Department Vandœuvre-lès-Nancy France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05183542 on ClinicalTrials.gov ↗ ← All trials in France