Abstract
Study Design
An inter- and intra-observer agreement study
Background
In recent years, vertebroplasty and kyphoplasty have been widely used in treating osteoporotic vertebral compression fractures (OVCF) though the clinical efficacy of them is still controversial. However, there are also inevitable complications, first and foremost is bone cement leakage (BCL). Yeom classification is commonly used to evaluate BCL. The objective of this study is to assess its reliability and reproducibility, and to explore its clinical application value.
Methods
All 58 patients with BCL following vertebroplasty/kyphoplasty were involved. Six spine surgeons were selected to be evaluators as they were unaware of the identity of the patients and the treatment they received. They classified BCL according to Yeom system, we used kappa (K) to assess the inter- and intra-observer agreement. After 12 weeks, we repeated the analysis.
Results
The inter-observer reliability of Yeom classification was substantial with K value of 0.71 (1st assessment) and 0.73 (2nd assessment). The intra-observer reproducibility of Yeom classification was near perfect with K value of 0.88.
Conclusion
Yeom classification system has substantial inter-observer reliability and near perfect intra-observer reproducibility in BCL following vertebroplasty/kyphoplasty, which can be widely used in clinical care as an appropriate instrument for early observation, mechanism and severity cognition, and prognosis predicting of BCL. Besides, the adding of type M (the mixed type) may improve the classification.
Acknowledgements
I want to thank my love, Du Ying, no matter how difficult it is, she never gives up, always cares for me, silently supports me, and gives me courage when I lose confidence. Without her help, understanding, tolerance and support, I believe that the life of a PhD in these three years will be very different.
Informed consent
Written patient consent was obtained for publication of all aspects of the case including personal and clinical details and images, which may compromise anonymity.
Patient consent
Written informed consent was obtained from the patient for publication of this study and any accompanying images.
Ethical approval
The case was reviewed by LongHua and ShuGuang Hospital Ethics Committee and ethical approval was waived as written consent was obtained from the patient.
Author contributions
Meng Shi, Yuwei Cai and Chongqing Xu are the co-first authors of this manuscript. Meng Shi, Yuwei Cai and Chongqing Xu designed the study and collected the data. Chongqing Xu, Mengchen Yin and Yisha Guo did the data analysis. Chongqing Xu wrote the manuscript. Mengchen Yin is the corresponding author who revised the manuscript and decided to submit the manuscript for publication. All authors read and approved the final manuscript.
Disclosure statement
All authors read and approved the final manuscript and declare that they have no competing interests.
Data availability statement
All supporting data can be provided upon request to the authors.