Status:
RECRUITING
SPECT/CT Bone Scan Quantification Surgery
Lead Sponsor:
Central Hospital, Nancy, France
Conditions:
Pseudoarthrosis of Bone
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
Detailed Description
Chronic low back pain is a public health problem and is the leading cause of work stoppage and the management of low back pain refractory to medical treatment involves surgical procedures such as arth...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 29 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT05183542
Start Date
April 29 2022
End Date
November 29 2025
Last Update
January 8 2025
Active Locations (1)
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1
Nuclear Medicine Department
Vandœuvre-lès-Nancy, France, 54511