Diagnostic Interest of Bone Tomoscintigraphy in the Search for Cervical Pseudarthrosis

NCT ID: NCT07140432

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-31
• Study Completion Date: 2027-02-28

Brief Summary

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.

Conditions

Cervical Pseudarthrosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Scintigraphy

Group Type: EXPERIMENTAL

Bone scintigraphy

Intervention Type: OTHER

A bone scintigraphy exam will be performed in addition of the already performed scanner in the current practice

Interventions

Bone scintigraphy

A bone scintigraphy exam will be performed in addition of the already performed scanner in the current practice

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ramsay Générale de Santé

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinique Convert ( INA)

Bourg-en-Bresse, , France

Site Status: RECRUITING

Countries

France

Facility Contacts

Bastien GREGOIRE, Dr

Role: primary

bastien.gregoire@ramsaysante.fr

+33474234317

Other Identifiers

2024-A00659-38

Identifier Type: -

Identifier Source: org_study_id