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一种新型种植体周围股骨骨折分类系统的初步协议研究。

A pilot agreement study of a new classification system for Peri-implant femoral fractures.

机构信息

Orthopaedic and Trauma Surgery Department, Hospital Consorci Sanitari Integral, Sant Joan Despí, Barcelona, Catalonia, Spain.

Orthopaedic and Trauma Surgery Department, Hospital Consorci Sanitari Integral, Sant Joan Despí, Barcelona, Catalonia, Spain.

出版信息

Injury. 2021 Jul;52(7):1908-1917. doi: 10.1016/j.injury.2021.04.021. Epub 2021 Apr 9.

Abstract

BACKGROUND

Peri-implant fractures occur in association with an implant, used to treat a previous injury that is still attached to the bone. We recently published a proposal for a classification system for peri-implant femoral fractures [Videla-Cés, Injury,2019].

AIM

To assess the agreement of our classification system for peri-implant femoral fractures among a group of future users of said classification system.

METHODS

A prospective, multicentre, international agreement pilot study was conducted among a group of independent traumatologists/orthopaedic surgeons (evaluators): senior (a minimum of 10 years' experience) and junior (in fourth or fifth training year). A set of 30 radiographs of peri-implant femoral fractures were selected (stratified into 3 levels of difficulty: low, medium and high). Each evaluator interpreted the radiographs on 2 different occasions separated by a period of one month and in a different order each time. The level of difficulty was masked from the evaluators and they had one week to classify the radiographs each time. Logistic regression and Cohen's kappa coefficient (κ) and its 95% confidence interval (95%CI) were used to assess the accuracy and agreement, both intra- and inter-evaluator. Between senior and junior surgeons was performed an exploratory analysis.

RESULTS

35 traumatologists/orthopaedic surgeons (17 senior and 18 junior) from 16 tertiary hospitals from 4 countries acted as evaluators. The accuracy, percentage of correct classifications (2 digits and 3 letters), in the first and second evaluation was: 56% (95%CI: 53-59%) and 55% (95%CI: 51-57%), respectively. (insert space) Negligible differences were found between junior and senior evaluators (first evaluation, OR: 1.46, 95%CI: 0.82-2.61, p-value: 0.199; second evaluation, OR: 1.06, 95%CI: 0.56-2.00, p-value: 0.860). (insert space) Both medium and low radiograph difficulty were associated with a lower probability of an incorrect classification compared with those of high difficulty (first evaluation, OR: 7.60, 95%CI: 5.24-11.05, p-value: <0.001; OR: 14.15, 95%CI: 9.12-21.96, p-value: <0.001, respectively; second evaluation, OR: 7.11, 95%CI: 4.88-10.38, p-value: <0.001, OR: 15.28, 95%CI: 9.77-23.89, p-value: <0.001). (insert space) The kappa for intra-observer agreement between the first and second evaluation was: 0.66, 95%CI: 0.63, 0.69. The kappa for inter-observer agreement considering all 30 radiographs was: 0.40, 95%CI: 0.40, 0.41 in the first evaluation and 0.39, 95%CI: 0.39, 0.40 in the second evaluation.

CONCLUSION

The proposed classification for peri-implant femoral fractures may be useful and user-friendly. Future studies are needed to assess the how clinically useful this classification system may be (the third phase in the validation process).

摘要

背景

种植体周围骨折是与种植体相关的骨折,用于治疗仍附着在骨头上的先前损伤。我们最近提出了一种种植体周围股骨骨折的分类系统[Videla-Cés,Injury,2019]。

目的

评估我们的种植体周围股骨骨折分类系统在该分类系统未来使用者中的一致性。

方法

对一组独立的创伤学家/骨科医生(评估者)进行了前瞻性、多中心、国际协议试点研究:高级(至少 10 年经验)和初级(第四或第五培训年)。选择了 30 例种植体周围股骨骨折的 X 光片(分为低、中、高 3 个难度级别)。每位评估者在两次不同的评估中对 X 光片进行解释,两次评估之间间隔一个月,每次评估的顺序都不同。难度级别对评估者是保密的,他们每次都有一周的时间对 X 光片进行分类。使用逻辑回归和 Cohen's kappa 系数(κ)及其 95%置信区间(95%CI)来评估准确性和一致性,包括评估者内部和评估者之间的一致性。对高级和初级外科医生进行了探索性分析。

结果

来自 4 个国家的 16 家三级医院的 35 名创伤学家/骨科医生(17 名高级和 18 名初级)担任评估者。第一次和第二次评估的准确性(2 位数和 3 个字母的正确分类百分比)分别为:56%(95%CI:53-59%)和 55%(95%CI:51-57%)。(插入空格)初级和高级评估者之间几乎没有差异(第一次评估,OR:1.46,95%CI:0.82-2.61,p 值:0.199;第二次评估,OR:1.06,95%CI:0.56-2.00,p 值:0.860)。(插入空格)中、低难度的 X 光片与高难度 X 光片相比,不正确分类的可能性较低(第一次评估,OR:7.60,95%CI:5.24-11.05,p 值:<0.001;OR:14.15,95%CI:9.12-21.96,p 值:<0.001;第二次评估,OR:7.11,95%CI:4.88-10.38,p 值:<0.001,OR:15.28,95%CI:9.77-23.89,p 值:<0.001)。(插入空格)第一次和第二次评估的观察者内一致性的 kappa 值分别为:0.66,95%CI:0.63,0.69。考虑到所有 30 张 X 光片的观察者间一致性的 kappa 值分别为:第一次评估时为 0.40,95%CI:0.40,0.41,第二次评估时为 0.39,95%CI:0.39,0.40。

结论

提出的种植体周围股骨骨折分类系统可能是有用和用户友好的。需要进一步的研究来评估这个分类系统在临床上的有用程度(验证过程的第三阶段)。

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