NCT05183542 SPECT/CT Bone Scan Quantification Surgery
| NCT ID | NCT05183542 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Central Hospital, Nancy, France |
| Condition | Pseudoarthrosis of Bone |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2022-04-29 |
| Primary Completion | 2027-01-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2022-04-29 with a primary completion date of 2027-01-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
El Mehdi SIAGHY, PhD
STUDY DIRECTOR
CHRU Nancy
Frequently Asked Questions
Who can join the NCT05183542 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pseudoarthrosis of Bone. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05183542 currently recruiting?
Yes, NCT05183542 is actively recruiting participants. Contact the research team at a.bahloul@chru-nancy.fr for enrollment information.
Where is the NCT05183542 trial being conducted?
This trial is being conducted at Vandœuvre-lès-Nancy, France.
Who is sponsoring the NCT05183542 clinical trial?
NCT05183542 is sponsored by Central Hospital, Nancy, France. The principal investigator is El Mehdi SIAGHY, PhD at CHRU Nancy. The trial plans to enroll 70 participants.