Diagnostic Interest of Bone Tomoscintigraphy in the Search for Cervical Pseudarthrosis (BOSCAR)

Ramsay Générale de Santé

Status: Enrolling

Conditions: Cervical Pseudarthrosis

Treatments: Other: Bone scintigraphy

Study type: Interventional

Funder types: Other

Identifiers

NCT07140432

2024-A00659-38

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 21 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients over 21 years of age
• Patients who have undergone cervical arthrodesis and are being treated at Clinique de la Sauvegarde or Clinique Convert
• Patients with a NDI clinical score at 1 year greater than 5
• Patient affiliated to/ or beneficiary of a Social Security scheme as definied by the law

Exclusion criteria

• Patients whose clinical condition requires rapid treatment that can't wait for examinations to be carried out
• Pregnancy and breastfeeding
• Protected person (curatorship, guardianship, safeguard of justice)
• History of hypersensitivity to the active substance ( sodium oxidronate) or to any of its constituents

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Scintigraphy

Experimental group

Treatment:

Other: Bone scintigraphy