Evaluation of the Effectiveness of a Technique Based on Inertial Sensors vs the Conventional Technique for the Execution of the Bone Resections in Primary Total Knee Arthroplasty: a Controlled Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Reduction in the number of cases in which the alignment error on the coronal plane is greater than 3°of error (outlier).
研究概览
简要总结
Comparison of surgical technique for the execution of bone resections in total knee arthroplasty.
Used technique are: a non-invasive extramedullary technique (EM technique) based on the use of inertial sensors for cutting guides positioning and conventional technique (IM technique), based on the use on intramedullary stem.
Our hypothesis is that the EM technique based on the use of inertial sensors leads to a reduction in the number of outliers equal to or greater than 20% compared to the outliers obtained with the conventional technique.
详细描述
Comparison of surgical technique for the execution of bone resections in total knee arthroplasty.
Used technique are: a non-invasive extramedullary technique (EM technique) based on the use of inertial sensors for cutting guides positioning and conventional technique (IM technique), based on the use on intramedullary stem. A study was carried out at the Rizzoli Orthopedic Institute in 2016 to compare non-invasive extramedullary technique (EM technique) and conventional technique (IM technique). Starting from the results obtained in the previous study, the objective of this study is to deepen the investigations to evaluate the effectiveness of the EM technique compared to the conventional IM technique.
The patients involved in the study will be divided into two groups based on the alignment technique used (EM technique and IM technique).
The results obtained will be measured on postoperative panoramic radiographs at discharge, assessing the overall alignment of the limb and the individual femoral and tibial components in terms of accuracy and repeatability according to a defined measurement protocol.
Primary endpoint:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
The evaluation of the results obtained will be carried out blindly by an examiner with adequate clinical skills to carry out the evaluation and who does not take part in the operational phases of the study.
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients candidated for total knee arthroplasty
- •hip mobility range of at least 30 °
- •BMI <35kg / m2
- •Aged between 40 and 80 years
排除标准
- •ipsilateral hip arthrodesis or ankylosis
- •non-perforable femoral medullary canal
- •165 °<HKA <195 °
- •BMI> 35kg / m2
结局指标
主要结局
Reduction in the number of cases in which the alignment error on the coronal plane is greater than 3°of error (outlier).
时间窗: 22 months
* HKA alignment on the coronal plane (medial angle between the femoral mechanical axis and the tibial mechanical axis) * coronal femoral angle (medial angle between the femoral mechanical axis and the tangent to the distal condyles of the femoral prosthetic component * tibial coronal angle (medial angle between the tibial mechanical axis and the tangent to the proximal profile of the tibial component) The number of patients with an HKA angle such that 180°-3°\> HKA\> 180°+ 3°or 180°-2°\> HKA\> 180°+ 2°will also be evaluated
次要结局
- Reduction of the period of hospital stay in the EM group compared to the group operated with the standard technique(22 months)
- Inter-operator variability in the EM group(22 months)
- Reduction of the variation in hemoglobin levels during hospitalization.(22 months)
- Reduction of alignment errors of the femoral and tibial resections obtained with the EM technique and with the IM technique on the sagittal plane(22 months)