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Value of CT to detect radiographically occult injuries of the proximal femur in elderly patients after low-energy trauma: determination of non-inferiority margins of CT in comparison with MRI

Abstract : To determine the margins of non-inferiority of the sensitivity of CT and the sample size needed to test the non-inferiority of CT in comparison with MRI. Materials and methods: During a 2-year period, elderly patients with suspected radiographically occult post-traumatic bone injuries were investigated by CT and MRI in two institutions. Four radiologists analyzed separately the CT and MRI examinations to detect post-traumatic femoral injuries. Their sensitivities at CT (SeCT) and MRI (SeMRI) were calculated with the reference being a best valuable comparator (consensus reading of the MRI and clinical follow-up). ROC analysis followed by an exact test (Newcombe's approach) was performed to assess the 95% confidence interval (CI) for the difference SeCT-SeMRI for each reader. A sample size calculation was performed based on our observed results by using a one-sided McNemar's test. Results: Twenty-nine out of 102 study participants had a post-traumatic femoral injury. SeCT ranged between 83 and 93% and SeMRI ranged between 97 and 100%. The 95% CIs for (SeCT-SeMRI) were [- 5.3%, + 0.8%], (pR1 = 0.1250), [- 4.5%; + 1.2%] (pR2 = 0.2188), [- 3.4%; + 1.1%] (pR3 = 0.2500) to [- 3.8%; + 1.6%] (pR4 = 0.3750) according to readers, with a lowest limit for 95% CIs superior to a non-inferiority margin of (- 6%) for all readers. A population of 440 patients should be analyzed to test the non-inferiority of CT in comparison with MRI. Conclusion: CT and MRI are sensitive for the detection of radiographically occult femoral fractures in elderly patients after low-energy trauma. The choice between both these modalities is a compromise between the most available and the most sensitive technique.
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https://hal.umontpellier.fr/hal-03352777
Contributeur : Nathalie Salvy-Córdoba Connectez-vous pour contacter le contributeur
Soumis le : jeudi 23 septembre 2021 - 14:53:58
Dernière modification le : mercredi 3 novembre 2021 - 05:13:56

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Solenne Lanotte, Ahmed Larbi, Nicolas Michoux, Marie-Pierre Baron, Aymeric Hamard, et al.. Value of CT to detect radiographically occult injuries of the proximal femur in elderly patients after low-energy trauma: determination of non-inferiority margins of CT in comparison with MRI. European Radiology, Springer Verlag, 2020, 30 (2), pp.1113-1126. ⟨10.1007/s00330-019-06387-2⟩. ⟨hal-03352777⟩

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