Diagnostic Interest of Bone Tomoscintigraphy in the Search for Cervical Pseudarthrosis

Overview

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.

Interventions

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

Primary outcome measures

• Evaluating the sensitivity, specificity and positive predictive value of bone scintigraphy to diagnose cervical pseudarthrosis compared to the reference method [Time frame: 12 months]

Secondary outcome measures (2)

• Comparison of the sensitivity, specificity, and positive predictive value (PPV) of CT-scan versus bone scintigraphy in diagnosing cervical pseudarthrosis [Time frame: 12 months]
• Assess the ability of scintigraphy to predict the probability of final consolidation in symptomatic patients at one year post arthrodesis [Time frame: 12 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

France · 1 center

• Clinique Convert ( INA) — Bourg-en-Bresse

Identifiers

NCT: NCT07140432 · 2024-A00659-38

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗