Diagnostic Interest of Bone Tomoscintigraphy in the Search for Cervical Pseudarthrosis

NCT07140432 | Recruiting

• 1 other identifier: 2024-A00659-38
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

cervical pseudarthrosis; imagining; hydric bone imagining; bone bridges; CT scans; diagnosis; cervical pain; bone scintigraphy; clinical presentation; diagnostic value

Outcome Measures

Primary Outcomes (1)

• Evaluating the sensitivity, specificity and positive predictive value of bone scintigraphy to diagnose cervical pseudarthrosis compared to the reference method

  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).

  12 months

Secondary Outcomes (2)

• Comparison of the sensitivity, specificity, and positive predictive value (PPV) of CT-scan versus bone scintigraphy in diagnosing cervical pseudarthrosis

  12 months

• Assess the ability of scintigraphy to predict the probability of final consolidation in symptomatic patients at one year post arthrodesis

  12 months

Study Arms (1)

Scintigraphy

EXPERIMENTAL

Other: Bone scintigraphy

Interventions

Bone scintigraphy OTHER

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

Scintigraphy

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ramsay Générale de Santé: lead

Study Sites (1)

Clinique Convert ( INA)

Bourg-en-Bresse, 01000, France

RECRUITING

MeSH Terms

Conditions

Disease; Neck Pain

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The scintigraphy examination will be interpreted, after reconstruction, on a via medical console (Siemens healthcare®) by two nuclear medicine physicians, blind to each other and to clinical data.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 24, 2025
• Study Start: December 31, 2024
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)