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Clinical Trial 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.

Clinical Trial 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 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05183542
Study type Interventional
Source Central Hospital, Nancy, France
Contact Achraf BAHLOUL, MD
Phone 383153911
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date May 2022
Completion date November 2025