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临床试验/NCT07140432
NCT07140432招募中不适用

Diagnostic Interest of Bone Tomoscintigraphy in the Search for Cervical Pseudarthrosis

GCS Ramsay Santé pour l'Enseignement et la Recherche2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年12月31日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
Evaluating the sensitivity, specificity and positive predictive value of bone scintigraphy to diagnose cervical pseudarthrosis compared to the reference method

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

盲法说明

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.

入排标准

年龄范围
21 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Scintigraphy

Experimental

干预措施: Bone scintigraphy (Other)

结局指标

主要结局

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

时间窗: 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).

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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