Three-Dimensional Hindfoot Alignment Measurements Based On Biplanar Radiographs: Prospective Clinical Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Biplanar radiography and 3D reconstruction of hindfoot
研究概览
简要总结
- The measurement of hindfoot alignment is a technical challenge.
- Today, hindfoot alignment is typically measured on hindfoot alignment view radiographs or long axial view radiographs. Measurements on both types of radiographs are hampered by technical shortcomings such as minimal rotational misplacement of the foot at the time of image acquisition. In previous publications our study groups demonstrated substantial measurement errors due to these shortcomings as well as bad interreader agreement.
- Hindfoot alignment measurement is feasible on MR images but hampered by the non-weight-bearing position of the patient and therefore not suited for pre-treatment evaluation.
- In an ex vivo study using plastic phantoms of a foot our research group could demonstrate superior interreader agreement and complete correction for foot misplacement at the time of image acquisition using a 3D secondary measurement technique based on biplanar low dose radiographs.
- Image acquisition using biplanar low dose radiographs is associated with a substantial reduction (about 1/7) of radiation dose applied to the patient compared to standard radiographs.
- Therefore the question arises if these excellent ex vivo results can be confirmed in a prospective clinical study.
Objectives:
- Evaluation of technical feasibility of 3D hindfoot alignment measurements based on biplanar radiographs.
- Reproduction of superior interreader agreement of measurements based on biplanar radiographs compared to measurements on conventional radiographs.
详细描述
Additional information to the brief summary:
Outcome(s): Hindfoot alignment measurement on standard radiographs and biplanar radiographs. The hindfoot angle is measured between the tibial axis and the calcaneal axis in degrees. Measurement results on plain films and based on 3D reconstructions will be compared.
Inclusion/Exclusion criteria:
- Inclusion: All patients referred for hindfoot alignment radiographs. These are all adults having suffered severe trauma or suffering from osteoarthrosis of the ankle joint. No inclusion of vulnerable participants.
- Exclusion criteria: Prior surgery, prior fracture, children and adolescents younger than the age of 20 years, known pregnancy.
Measurements and Procedures: Measurement of hindfoot alignment based on conventional radiographs and based on biplanar radiographs by two independent radiologists. Comparison of measurement results (paired-t-test, Wilcoxon signed-rank test) and calculation of interreader agreement (Intraclass correlation coefficient).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients referred for hindfoot alignment radiographs. These are all adults having suffered severe trauma or suffering from osteoarthrosis of the ankle joint. No inclusion of vulnerable participants.
排除标准
- •Prior surgery, prior fracture, children and adolescents younger than the age of 20 years, known pregnancy.
结局指标
主要结局
Biplanar radiography and 3D reconstruction of hindfoot
时间窗: The measurement is performed immediately after image acquisition.
Hindfoot alignment is measured between the tibial axis and the calcaneal axis in degrees. Measurement on standard radiographs and biplanar radiographs are then compared.
次要结局
未报告次要终点