Diagnostic Interest of Bone Tomoscintigraphy in the Search for Cervical Pseudarthrosis

Not Applicable

Recruiting

• Conditions: Cervical Pseudarthrosis

• Registration Number: NCT07140432
• Lead Sponsor: Ramsay Générale de Santé

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-31
• Status Verified: 2025-08
• Study First Submitted: 2025-08-11
• Study First Submitted QC: 2025-08-18
• Last Update Submitted: 2025-08-18
• Study First Posted: 2025-08-24
• Last Update Posted: 2025-08-24
• Primary Completion: 2027-02-28
• Study Completion: 2027-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Evaluating the sensitivity, specificity and positive predictive value of bone scintigraphy to diagnose cervical pseudarthrosis compared to the reference method	12 months	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).

Secondary Outcome Measures

Name	Time	Method
Comparison of the sensitivity, specificity, and positive predictive value (PPV) of CT-scan versus bone scintigraphy in diagnosing cervical pseudarthrosis	12 months	Sensitivity, specificity, and positive predictive value (PPV) of CT-scan 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) and then compared to the results for bone scintigraphy using a McNemar comparison as well as a Chi-2 test.
Assess the ability of scintigraphy to predict the probability of final consolidation in symptomatic patients at one year post arthrodesis	12 months	Final consolidation will be defined by the presence of bone bridges greater than 4 mm in at least two of the three sectors (anterior, middle, posterior) based on CT scan data at 2 years post-surgery.; For the assessment of the probability of final consolidation, hyperfixation of at least one bone bridge greater than 4 mm wide (over its entire height), limited to one of the three sectors (anterior, middle, posterior) without the pseudarthrosis criteria described above, will be defined as a good probability of final consolidation. The presence of bone bridges more than 4 mm wide, over their entire height, with or without hyperfixation in at least two of the three sectors, will be defined as good consolidation

Trial Locations

Locations (1)

Clinique Convert ( INA); 🇫🇷 Bourg-en-Bresse, France