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New treatment option for Pseudoarthrosis of Bone
Official title SPECT/CT Bone Scan Quantification Surgery
ClinicalTrials.gov ID: NCT05183542
What this study is testing
What is Bone scan?
Bone scan is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for pseudoarthrosis of bone.
Also referred to as Scales of pain.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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).
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Vandœuvre-lès-Nancy, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vandœuvre-lès-Nancy, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.