Predictive Performance of SPECT/CT Bone Scan Quantification Before Lumbar Arthrodesis

2021PI050

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.

2022-04-29

2024-04-29

2025-11-29

Recruiting

70

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Persons to be operated on for lumbar arthrodesis by the neurosurgery team of the Nancy CHRU and respecting the eligibility criteria (including neuropathic pain scale score \\< 4, see non-inclusion criteria), will be proposed to participate in the study', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 70, 'type': 'ESTIMATED'}}

2023-03-30