Cervical PseudarthrosisBOSCARNCT07140432
Diagnostic Interest of Bone Tomoscintigraphy in the Search for Cervical Pseudarthrosis
A study testing Bone scintigraphy in people with Cervical Pseudarthrosis, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Cervical Pseudarthrosis
- What is being tested?
- Bone scintigraphy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 31 Dec 2024to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Clinique Convert ( INA)
Bourg-en-Bresse, 01000
Bastien GREGOIRE, Dr, +33474234317, bastien.gregoire@ramsaysante.fr
Bastien GREGOIRE, Dr
About this study
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.
Read more
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
- Being tested
- Bone scintigraphy
- Keywords
- cervical pseudarthrosis, imagining, hydric bone imagining, bone bridges, CT scans, diagnosis, cervical pain, bone scintigraphy, clinical presentation, diagnostic value
- Medical subject headings
- Disease, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone scintigraphyOther
A bone scintigraphy exam will be performed in addition of the already performed scanner in the current practice
| Study group | Role | What they receive |
|---|---|---|
| Scintigraphy | Experimental | Not described Receives: Other: Bone scintigraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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.
Measured: 12 months
Assess the ability of scintigraphy to predict the probability of final consolidation in symptomatic patients at one year post arthrodesis
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start31 Dec 2024
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical PseudarthrosisStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140432
- Sponsor's protocol ID
- 2024-A00659-38
- Acronym
- BOSCAR
- Status last verified
- Jul 2026
- First submitted
- 11 Aug 2025
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Interest of Bone Tomoscintigraphy in the Search for Cervical Pseudarthrosis
- ClinicalTrials.gov ID
- NCT07140432
- Acronym / sponsor ID
- BOSCAR / 2024-A00659-38
- Conditions
- Cervical Pseudarthrosis
- Keywords
- cervical pseudarthrosis, imagining, hydric bone imagining, bone bridges, CT scans, diagnosis, cervical pain, bone scintigraphy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 31 Dec 2024 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 24 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Scintigraphy | Experimental | Other: Bone scintigraphy |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone scintigraphyA bone scintigraphy exam will be performed in addition of the already performed scanner in the current practice | Other | Scintigraphy |
Primary outcome
Evaluating the sensitivity, specificity and positive predictive value of bone scintigraphy to diagnose cervical pseudarthrosis compared to the reference method
Time frame: 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).
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone scintigraphy in people with Cervical Pseudarthrosis, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluating the sensitivity, specificity and positive predictive value of bone scintigraphy to diagnose cervical pseudarthrosis compared to the reference method (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.