Nuclear Medicine Department
Vandœuvre-lès-Nancy, 54511, France
Location status: Recruiting
NCT Number: NCT05183542
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.
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Request Info18 year and older
All sexes
Interventional
Not applicable
Vandœuvre-lès-Nancy, 54511, France
Location status: Recruiting
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 arthrodesis, aimed at fusing several adjacent vertebrae.
The main gold standard tests for assessing the effectiveness of surgery are the Oswestry Disability Index (ODI), which takes into account the impact on quality of life and the numerical pain scale (EN). The ODI consists of 10 questions In order to compensate for the effect of analgesics on the ODI and EN scores, the response to both questionnaires should take into account the patient's symptomatology throughout the previous week.
A decrease in the score of these 2 scales by at least the value of the MCID (Minimal Clinically Important Difference) is necessary to conclude a good response to surgery . The MCID value is 10% (0-100% score) for the Oswestry Disability Index (ODI) and 19 points (0-100 point scale) for the Numerical Pain Scale (EN) respectively. Standard diagnostic investigations performed during the preoperative workup for arthrodesis, mainly include X-rays, CT and lumbar MRI but not bone scans. None of the current standard preoperative examinations can identify a group of people without improvement after surgery. semiconductor cameras, allow bone scans with CT recordings coupled to a CT scan (SPECT/CT) offering better performance compared to a conventional camera . If abnormalities are detected, the binding intensity of the radiopharmaceutical is not only assessed visually but can also be quantified by the Standardized Uptake Value (SUV).
To date, no preoperative examination that can predict the clinical evolution after lumbar arthrodesis has been reported apart from bone scintigraphy with visual assessment of fixation. Finding a threshold value for SUVmax to predict clinical outcome after surgery would potentially have an impact on the selection of "good responders" to lumbar spine arthrodesis, with other patients benefiting from medical treatment combined with rehabilitation.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
Other names: Scales of pain
Time frame: 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
Time frame: 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 numeric scale (NS) measured at 12 months after surgery
Time frame: 24 months
To determine whether SUVmax measured at early time on bone scans predicts a good response to lumbar spine fusion surgery according to the Oswestry Disability Index (ODI) measured at 12 months after surgery.
Time frame: 24 months
To determine whether SUVmax measured at early time on bone scans predicts a good response to lumbar spine fusion surgery according to the Numeric Scale (NS) measured at 12 months after surgery.with Numeric Scale (NS)
Contact information is provided by the study sponsor or research team.
Central Hospital, Nancy, France
Other
Predictive Performance of SPECT/CT Bone Scan Quantification Before Lumbar Arthrodesis
Acronym: PERQUAL
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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