Evaluation of the Relation Between the Rotation Angle of the Talar Component and the Antero-medial Pain in Patients Underwent Total Ankle Replacement, at Least One Year After Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Phi angle
研究概览
简要总结
The study evaluates the relation between the rotational alignment of the talar component (phi angle) and the antero-medial ankle pain in patients underwent total ankle replacement, at least one year after surgery.
Moreover, the study aims to define a range of the phi angle associated with a lower frequency of antero-medial pain.
详细描述
Background:
In case of total ankle prosthesis surgery, the correct positioning of the talar component is one of the most challenging tasks. When performing total ankle replacement, the primary goal for long-term implant survival is to restore a physiological alignment of the prosthesis in the lateral and frontal planes. In fact, an incorrect alignment can alter joint mechanics and joint reactive forces that can lead to implant failure (Saltzman, 2004).
Regarding the rotation in the dorsoplantar plane, the prosthesis is aligned taking as reference the axis of the second metatarsal bone, with the foot in neutral position (Roukis, 2015). In this regard, there are no specific mechanical-articular considerations as for the lateral and frontal planes. However, it is expected that misalignments of the prosthesis in the dorsoplantar plane may involve the presence of antero-medial pain in the ankle in the long term (at least 1 year after surgery).
At present, no previous studies have verified whether there is a relation between the rotational alignment of the talar component in the dorsoplantar plane and the frequency of antero-medial ankle pain, at least 1 year after surgery. This evaluation can provide useful information for a more advantageous placement of the implant during the intervention.
Aim of the Study:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •previous intervention of first implant of total ankle replacement, with at least 12 months of follow up and maximum 36 months
排除标准
- •more than 36 months from the surgery of first implant of total ankle replacement
- •previous revision surgery of ankle prosthesis
- •previous intervention of ankle disarthrodesis and ankle prosthesis implant
结局指标
主要结局
Phi angle
时间窗: Through study completion, an average of 18 months
Relative angle (measured in degrees) between the alignment of the talar component of the implant, and the axis passing through the second metatarsal bone, in the dorsoplantar plane.
Antero-medial ankle pain
时间窗: Through study completion, an average of 18 months
Sum of the antero and medial pain areas, measured as percentage with respect to the total body area in the considered plane.
次要结局
未报告次要终点