Specific Orientation in Anterior Cruciate Ligament Reconstruction: a Clinical Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Accuracy
研究概览
简要总结
Rationale: In anterior cruciate ligament (ACL) reconstruction, anatomical femoral tunnel positioning has proven to be difficult with current techniques. Limited visibility during surgery and high interpersonal variability are mainly responsible for non-anatomical femoral tunnel positioning. Non anatomical tunnel positioning can lead to long term failure of the reconstruction. In order to obtain an accurate and constant anatomical femoral tunnel position during ACL reconstruction, a patient specific surgical guide has been developed.
Objective: to assess the accuracy of the newly developed patient specific femoral aimer used during ACL reconstruction.
Study design: pilot study
Study population: 10 subjects (>16 years of age ) with ACL injury, requiring ACL reconstruction.
Intervention: all subjects will undergo ACL reconstruction in which a patient specific surgical guide is used for femoral tunnel positioning.
Main study parameters/endpoints: the main study parameter is the difference between the planned femoral tunnel position and the achieved tunnel position. This difference is quantified in both mm (translation) and degrees (rotation).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: No additional perioperative risks are associated with participation. Based on previous cadaver experiments, the accuracy of the patient specific, 3D printed femoral aimer is high. Subjects will undergo 1 postoperative MRI which will take place during a routine scheduled follow up visit.
详细描述
In order to perform a patient specific ACL reconstruction we have developed a surgical instrument (SONAR femoral Aimer PSI) that can be used during an outside-in ACL reconstruction.
The SONAR femoral Aimer PSI is an adaption to the RetroConstruction™ Guide, type AR-1510 used in the GraftLink® technique. This technique is now used in approximately 70% of ACL reconstructions in the Netherlands (information supplied by Arthrex).
In the SONAR femoral Aimer PSI the tip of the guide is designed for each individual patient based on the pre-operative MRI. In the 3D laboratory from the UMCG, the images from the MRI are loaded in a software program used for digital image processing called Mimics.
Using Mimics, the bone and cartilage of the distal femur are segmented, which is a digital method to create a 3D model of the distal femur and overlying cartilage.
Based on this 3D model, a negative mold is created which fits the intercondylar notch of the knee. This patient specific design is transferred to the Research Instrument Manufactory (RIM) of the UMCG. At the RIM a computerized cutter with 6 degrees of freedom is used to create the SONAR femoral aimer PSI from stainless steel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>16 years
- •Primary ACL injury requiring ACL reconstruction
排除标准
- •No preoperative MRI available.
- •Inability to understand the Dutch language (assessed by the treating physician)
结局指标
主要结局
Accuracy
时间窗: 2 weeks post surgery
Deviation in mm of realised femoral tunnel position compared to planned femoral tunnel position. Measured on pre and postoperative MRI
次要结局
- Complications(2 weeks post surgery)