Clinique Convert ( INA)
Bourg-en-Bresse, 01000, France
Location status: Recruiting
Location contact
Bastien GREGOIRE, Dr
CONTACT
Bastien GREGOIRE, Dr
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07140432
Cervical pseudarthrosis is a classic complication and a challenge for challenge for spine surgeons. The rate of pseudarthrosis can range from 3 to 15%, and depend greatly on the patient, the approach the number of levels operated on.
Although some patients remain asymptomatic, most require revision surgery instability, cervical or radicular pain. Diagnosis of cervical pseudarthrosis remains difficult. The clinical presentation is non-specific, and there is no consensus on the imaging imaging. Radiographic evaluation lacks sensitivity. The dynamic images require prior calibration and anatomical landmarks difficult to visualize. Angle measurement lacks reproducibility and sensitivity. CT scans, currently considered the gold standard as the gold standard, provides valuable morphological data but does not provide information on the functional nature of bone bridges the functional nature of bone bridges and apparent consolidation, particularly incomplete.
At the same time, functional imaging using bone scintigraphy has been historically limited by lack of spatial resolution, absence of anatomical and radiation attenuation for deep structures.The advent of hybrid imaging makes it possible to these limitations. Recently, the 6 to 16 scanners fitted to gamma cameras enable a detailed study correlations between functional and anatomical data.
Interpretation criteria remain unestablished, however, and only one study reports the use of hydric bone imaging in the study of cervical pseudarthrosis. All patients were positive on scintigraphy. However, given the absence of "healthy" patients and the small number of patients the diagnostic value of bone scintigraphy in this indication.
Interested in participating?
Request Info21 year–99 year
All sexes
Interventional
Not applicable
Bourg-en-Bresse, 01000, France
Location status: Recruiting
Bastien GREGOIRE, Dr
CONTACT
Bastien GREGOIRE, Dr
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A bone scintigraphy exam will be performed in addition of the already performed scanner in the current practice
Time frame: 12 months
Sensitivity, specificity, and positive predictive value (PPV) will be evaluated against the reference method (based on intraoperative observation of hypermobility in cases of surgical revision and/or follow-up at 6 months (+/-1 month) and 12 months (+/-1 month) in the absence of surgical revision).
Time frame: 12 months
Sensitivity, specificity, and positive predictive value (PPV) of CT-scan will be evaluated against the reference method (based on intraoperative observation of hypermobility in cases of surgical revision and/or follow-up at 6 months (+/-1 month) and 12 months (+/-1 month) in the absence of surgical revision) and then compared to the results for bone scintigraphy using a McNemar comparison as well as a Chi-2 test.
Time frame: 12 months
Final consolidation will be defined by the presence of bone bridges greater than 4 mm in at least two of the three sectors (anterior, middle, posterior) based on CT scan data at 2 years post-surgery.
For the assessment of the probability of final consolidation, hyperfixation of at least one bone bridge greater than 4 mm wide (over its entire height), limited to one of the three sectors (anterior, middle, posterior) without the pseudarthrosis criteria described above, will be defined as a good probability of final consolidation. The presence of bone bridges more than 4 mm wide, over their entire height, with or without hyperfixation in at least two of the three sectors, will be defined as good consolidation
GCS Ramsay Santé pour l'Enseignement et la Recherche
Other
Acronym: BOSCAR
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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.
Published trials that share one or more normalized conditions with this study.
NCT07601425
Arteriovenous Malformations, Cardiovascular Abnormalities
Boston, Massachusetts, United States
View Trial DetailsNCT07728513
AI-Assisted Diagnosis, Disease
Lahore, Punjab Province, Pakistan
View Trial DetailsNCT07725861
Cervical Pain, Neck Pain
Multan, Punjab Province, Pakistan
View Trial DetailsNCT07725510
Disease, Pathologic Processes
Guangzhou, Guangdong, China
View Trial Details