Assessing the Efficacy of a Preoperative Navigation System in Anterior Cruciate Ligament Reconstruction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Evaluation of Bone Tunnel Footprint Localization Accuracy
研究概览
简要总结
The ACL surgery robot features a preoperative navigation system that enhances the precision of bone tunnel placement. As the first dual-bundle reconstruction surgical robot developed in China, it integrates advanced technology to ensure accurate anatomical alignment. This multi-center study aims to evaluate the robot's effectiveness in improving surgical outcomes and reducing complications, demonstrating the potential of domestic innovations in orthopedic surgery. With its high accuracy in locating bone tunnel footprints, this robot represents a significant advancement in ACL reconstruction techniques.
The trial is designed as a randomized controlled trial (RCT) led by a prospective randomized cohort. The study is initiated by Tsinghua University's long-term professor, Yu Jiakuo, and the product has received China's Class III clinical registration certificate.
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)
盲法说明
Throughout the clinical study, efforts should be made to keep participants blinded; however, since participants can learn which surgical instruments they used by obtaining a copy of their hospital records upon discharge, the blinding in this clinical study should be maintained as much as possible until the participants automatically unblind themselves.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preoperatively, the participant or guardian is willing and able to sign the informed consent form;
- •Patients aged 18 to 80 years (inclusive of 18 and 80 years), regardless of gender;
- •Patients who meet the diagnostic criteria for anterior cruciate ligament (ACL) tear and have no contraindications for implantation;
- •Patients with mature skeletons;
- •Good compliance and willingness and ability to participate in follow-up observations as required.
排除标准
- •(1) Participants who have previously participated in other clinical studies of drugs, biological agents, or medical devices but did not meet the primary study endpoint within the specified timeframe; (2) Patients with a known allergy to one or more implanted materials; (3) Patients who are physically frail or unable to tolerate surgery due to other systemic diseases; (4) Presence of active infectious lesions in the knee joint or other parts of the body; (5) Obesity with a BMI > 35; (6) Patients with severe diabetes (acute complications of diabetes, preoperative random blood glucose ≥ 16.7 mmol/L with or without altered consciousness, such as diabetic ketoacidosis, suspected diabetic ketoacidosis, hyperglycemic hyperosmolar state, or lactic acidosis; chronic complications of diabetes leading to severe target organ damage requiring urgent treatment, such as acute cardiovascular and cerebrovascular diseases, renal insufficiency, severe vision loss due to retinal disease, intermittent claudication and ischemic symptoms due to peripheral vascular disease, diabetic foot); (7) Women who are pregnant or breastfeeding; (8) Drug users and substance abusers; (9) Patients who are mentally incapacitated or unable to understand the requirements for participating in the study, making cooperation difficult; (10) Those expected to have poor compliance, unwilling or unable to follow postoperative therapy and/or rehabilitation program instructions; (11) Other comorbid conditions that limit participation in the study, hinder compliance with follow-up, or affect the scientific integrity of the study; (12) Other conditions judged by the investigator to be unsuitable for inclusion.
结局指标
主要结局
Evaluation of Bone Tunnel Footprint Localization Accuracy
时间窗: One week post-surgery
The localization of bone tunnels is evaluated by comparing the deviation of each tunnel's position from its preoperative planned position at one week post-surgery (hereinafter referred to as "bone tunnel deviation value"). At one week post-surgery, each participant undergoes CT three-dimensional imaging of the knee joint on the surgical side, and the bone tunnel positions of the reconstructed ACL on the femur and tibia are measured. The measurement of the femoral tunnel uses the Bernard and Hertel method, measuring the ratio of the center point of the femoral tunnel relative to the Blumensaat line in terms of the horizontal length and height of the lateral femoral condyle. The measurement of the tibial tunnel uses the Stäubli and Rauschning method, measuring the ratio of the center point of the tibial tunnel in relation to the anterior-posterior and medial-lateral dimensions of the tibial plateau. Each research center has designated researchers review the images, and each tunnel cente
次要结局
- Lysholm score(At preoperative, 6 weeks postoperative, 3 months postoperative, 12 months, and 24 months.)
- Relative Anterior Translation of the Tibia(At preoperative, 6 weeks postoperative, 3 months postoperative, 12 months, and 24 months.)
- Knee Flexion and Extension Angle (Range of Motion)(At preoperative, 6 weeks postoperative, 3 months postoperative, 12 months, and 24 months.)
- International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC)(At preoperative, 6 weeks postoperative, 3 months postoperative, 12 months, and 24 months.)
- Tegner Knee Activity Scale(*At preoperative, 6 weeks postoperative, 3 months postoperative, 12 months, and 24 months.)
- Visual Analog Scale (VAS) Score(At preoperative, 6 weeks postoperative, 3 months postoperative, 12 months, and 24 months.)