Abstract：
OBJECTIVE: To characterize the intra- and inter-operator reliability of a CT-based 3D preoperative planning software.
METHODS: This study analyzed 30 CT scans of de-identified knees with osteoarthritis. For each scan, a case planner segmented the bones and pre-planned the TKA. Three orthopedic surgeons then reviewed each pre-planning three times at least one week apart, in a blinded manner. During the reviews, the surgeons modified the pre-plannings until they felt the plannings matched the objectives defined collegially at the beginning of the study. Reliability was assessed using the Intraclass Correlation Coefficient (ICC) and the Standard Error of Measurement (SEM).
RESULTS: The intra- and inter-operator reliabilities for implant size selection were almost perfect (ICC between 0.97 and 0.99). Implants of same sizes were selected in 67.1-90.0% of cases. For implant placements, almost perfect intra- and inter-operator reliability was observed in all degrees-of-freedom (ICC between 0.81 and 1.00), except in flexion-extension for the femur (intra-operator ICC between: 0.76 and 0.99; inter-operator ICC of 0.61) and the tibia (intra-operator ICC between 0.12 and 1.00; inter-operator ICC of 0.03). All implant placements SEM were below 1.3 mm or 1.7°.
CONCLUSIONS: This study showed high intra- and inter-operator reliability for implant size selection and, in most of the degrees-of-freedom, also for implant placements. Further research is needed to evaluate the benefit of developing more precise means of describing the objectives of the surgical planning as well as to evaluate the possibility and relevance of adding features in the planning software to assist the operators.
METHODS: This study analyzed 30 CT scans of de-identified knees with osteoarthritis. For each scan, a case planner segmented the bones and pre-planned the TKA. Three orthopedic surgeons then reviewed each pre-planning three times at least one week apart, in a blinded manner. During the reviews, the surgeons modified the pre-plannings until they felt the plannings matched the objectives defined collegially at the beginning of the study. Reliability was assessed using the Intraclass Correlation Coefficient (ICC) and the Standard Error of Measurement (SEM).
RESULTS: The intra- and inter-operator reliabilities for implant size selection were almost perfect (ICC between 0.97 and 0.99). Implants of same sizes were selected in 67.1-90.0% of cases. For implant placements, almost perfect intra- and inter-operator reliability was observed in all degrees-of-freedom (ICC between 0.81 and 1.00), except in flexion-extension for the femur (intra-operator ICC between: 0.76 and 0.99; inter-operator ICC of 0.61) and the tibia (intra-operator ICC between 0.12 and 1.00; inter-operator ICC of 0.03). All implant placements SEM were below 1.3 mm or 1.7°.
CONCLUSIONS: This study showed high intra- and inter-operator reliability for implant size selection and, in most of the degrees-of-freedom, also for implant placements. Further research is needed to evaluate the benefit of developing more precise means of describing the objectives of the surgical planning as well as to evaluate the possibility and relevance of adding features in the planning software to assist the operators.
摘要：
目的：表征基于CT的3D术前计划软件的操作员内和操作员间可靠性。
方法：本研究分析了30例膝关节骨性关节炎的CT扫描。对于每次扫描，病例规划师分割骨骼并预先计划TKA。然后，三名整形外科医生至少间隔一周三次审查每个预先计划，以盲目的方式。在审查期间,外科医生修改了预计划,直到他们认为计划与研究开始时大学确定的目标一致.使用组内相关系数(ICC)和测量标准误差(SEM)评估可靠性。
结果：植入物尺寸选择的操作员内部和操作员之间的可靠性几乎是完美的（ICC在0.97和0.99之间）。67.1-90.0%的病例选择了相同大小的植入物。对于植入物放置,在所有自由度（ICC在0.81和1.00之间）中观察到几乎完美的操作员内部和操作员之间的可靠性，股骨(操作者内部ICC在0.76和0.99之间;操作者之间ICC在0.61)和胫骨(操作者之间ICC在0.12和1.00之间;操作者之间ICC在0.03)的屈伸除外。所有植入物放置SEM均低于1.3mm或1.7°。
结论：这项研究显示了植入物尺寸选择的操作人员内部和操作人员之间的高度可靠性，在大多数自由度中，也用于植入物放置。需要进一步的研究来评估开发更精确的方法来描述手术计划的目标以及评估在计划软件中添加功能以帮助操作员的可能性和相关性的益处。
方法：本研究分析了30例膝关节骨性关节炎的CT扫描。对于每次扫描，病例规划师分割骨骼并预先计划TKA。然后，三名整形外科医生至少间隔一周三次审查每个预先计划，以盲目的方式。在审查期间,外科医生修改了预计划,直到他们认为计划与研究开始时大学确定的目标一致.使用组内相关系数(ICC)和测量标准误差(SEM)评估可靠性。
结果：植入物尺寸选择的操作员内部和操作员之间的可靠性几乎是完美的（ICC在0.97和0.99之间）。67.1-90.0%的病例选择了相同大小的植入物。对于植入物放置,在所有自由度（ICC在0.81和1.00之间）中观察到几乎完美的操作员内部和操作员之间的可靠性，股骨(操作者内部ICC在0.76和0.99之间;操作者之间ICC在0.61)和胫骨(操作者之间ICC在0.12和1.00之间;操作者之间ICC在0.03)的屈伸除外。所有植入物放置SEM均低于1.3mm或1.7°。
结论：这项研究显示了植入物尺寸选择的操作人员内部和操作人员之间的高度可靠性，在大多数自由度中，也用于植入物放置。需要进一步的研究来评估开发更精确的方法来描述手术计划的目标以及评估在计划软件中添加功能以帮助操作员的可能性和相关性的益处。
