(Étude de la cinématique Tridimensionnelle du Genou et Guidage Chirurgical Minimalement Effractifs Par Recalage Rigide échographique)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- 3D knee kinematic assessment
研究概览
简要总结
Problem:
Currently, no system allows precise kinematic assessment of the knee and accurate guiding of orthopedic surgical actions in a minimally invasive fashion. However, such a system would prove useful in the clinical setting to improve the quality of surgical interventions at the knee.
Hypothesis:
A novel knee kinematic assessment and surgical guidance tool using 3D personalized imaging and minimally invasive bony fixation allows precise kinematic assessment and surgical guidance in the routine clinical setting.
Objectives :
- Demonstrating the capacity of the system to precisely measure 3D knee kinematics
- Quantifying the reproducibility of the kinematic measurements
- Measuring the impact of knee surgical procedures on knee kinematics
- Assessing the correlations between measured articular kinematics and clinical results after knee surgery
- Integrating the novel measuring system to the surgical flow of three knee surgical procedures
- Quantifying the precision and reproducibility of the surgical actions guided by the system
- Comparing the clinical results of surgeries guided by the system to those performed with the traditional technique
详细描述
A novel knee kinematic assessment and surgical guidance tool using 3D personalized imaging and minimally invasive bony fixation allows precise kinematic assessment and surgical guidance in the routine clinical setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Patients awaiting a knee surgery (total knee arthroplasty (TKA), high tibial osteotomy (HTO), anterior cruciate ligament reconstruction(ACLR))
排除标准
- •Active infection
- •Atypical morphology and/or alignment of the lower limbs
- •Knee instability (other than secondary to ACL deficiency in patients awaiting ACLR)
- •Knee flexion contracture of 10 degrees or more
- •Knee flexion of less than 120 degrees
结局指标
主要结局
3D knee kinematic assessment
时间窗: 1 day
The system should be able to precisely and reproducibly measure 3D knee kinematics (tibio-femoral flexion, abduction-adduction, transverse rotation, and anterio-posterior and medio-lateral translations)
Precision of guided surgical actions
时间窗: On post-operative imaging (six weeks after surgery)
The system should allow the surgeon to realize surgical actions, like bone cuts and guide-wire placement, within one degree and one millimeter of the desired target.
次要结局
- Clinical results(At each post-operative visit (six weeks, six months, one year, and two years after surgery))