Bone scintigraphy to find cervical pseudarthrosis
Diagnostic Interest of Bone Tomoscintigraphy in the Search for Cervical Pseudarthrosis
This trial will test whether bone scintigraphy can help detect cervical pseudarthrosis in adults who had prior cervical fusion and still have neck symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 21 Years to 99 Years |
| Sex | All |
| Sponsor | Ramsay Générale de Santé Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Bourg-en-Bresse) |
| Trial ID | NCT07140432 on ClinicalTrials.gov |
What this trial studies
The trial enrolls adults over 21 who previously underwent cervical arthrodesis and have persistent symptoms with an NDI score greater than 5 about one year after surgery. Participants will undergo bone scintigraphy with sodium oxidronate in addition to standard imaging such as CT to look for functional signs of nonunion. The aim is to determine whether functional bone imaging provides information about the nature of bone bridges and incomplete consolidation that CT morphology alone does not capture. Imaging findings will be compared with clinical signs and existing radiologic data to inform diagnostic accuracy and potential need for revision surgery.
Who should consider this trial
Good fit: Adults over 21 who had cervical fusion, are followed at the participating clinics, have an NDI greater than 5 at one year post‑op, and have social security coverage are the intended participants.
Not a fit: Patients needing urgent treatment, pregnant or breastfeeding individuals, those under legal protection, or anyone with known hypersensitivity to sodium oxidronate will not be eligible and are unlikely to benefit.
Why it matters
Potential benefit: If successful, bone scintigraphy could improve detection of cervical nonunion and help target revision surgery to patients who truly need it.
How similar studies have performed: Functional bone scintigraphy has shown promise in spine fusion contexts but has limited high‑quality validation specifically for cervical pseudarthrosis, while CT remains the morphological gold standard.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bourg-en-Bresse
- Clinique Convert ( INA) — Bourg-en-Bresse, France (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.