Robotic Assistance for Tunnel Positioning in Anterior Cruciate Ligament Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Accuracy of tunnel positioning
研究概览
简要总结
Accurate ideal graft tunnel positioning is essential for the successful application of anatomic anterior cruciate ligament (ACL) reconstruction. The accurate insertion of the tibial tunnel (TT) and femoral tunnel (FT) remain a challenge.
A robotic assisted new strategy for drill TT and FT in ACL reconstruction will be performed and its efficacy and accuracy will be assess.
The investigators will prospectively include 30 patients with ACL rupture requiring surgical treatment. The reconstruction will be performed with hamstring tendon graft or patellar tendon graft. The femoral and tibial tunnels placement will be guided by the Rosa robot (Zimmer®).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients treated at CHU Amiens-Picardie for ACL reconstruction by practitioner who has robot experience.
- •children and adults from 10 to 45 years old
排除标准
- •Patients managed by another ACL reconstruction technique
- •Patients under guardianship, curators deprived of liberty
- •Pregnant and nursing women.
- •Patient who refused to participate in the study and to sign informed consent
研究组 & 干预措施
rosa robot assistance
Patients with ACL rupture requiring surgical treatment will be included. The reconstruction will be performed with hamstring tendon graft or patellar tendon graft. The femoral and tibial tunnels placement will be guided by the Rosa robot (Zimmer®).
干预措施: anatomic anterior cruciate ligament (ACL) reconstruction (Procedure)
结局指标
主要结局
Accuracy of tunnel positioning
时间窗: Day 0; during the operation
Accuracy of tunnel positioning will be evaluated by comparing the theoretical intraoperative position and the actual post-operative position by image fusion
次要结局
- Range of motion of the knee(day 0, during operation)
- Knee stability(up to 2 years; during follow-up)