ACL footprint localization after preoperative navigation executed by robotic armACL footprint localization after preoperative navigation executed by rmanual execution
ACL footprint localization after preoperative navigation executed by robotic arm: Anterior cruciate ligament (ACL) reconstruction is performed using the preoperative navigation of Naton Robotics, followed by random assignment to either robotic surgery or traditional manual surgery. The difference between the two lies in whether the localization of the ACL footprint is performed by a human or by the robotic arm. The surgical technique is standardized as double-bundle reconstruction.
ACL footprint localization after preoperative navigation executed by rmanual execution: Anterior cruciate ligament (ACL) reconstruction is performed using the preoperative navigation of Naton Robotics, followed by random assignment to either robotic surgery or traditional manual surgery. The difference between the two lies in whether the localization of the ACL footprint is performed by a human or by the robotic arm. The surgical technique is standardized as double-bundle reconstruction.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
1. Preoperatively, the participant or guardian is willing and able to sign the informed consent form;
2. Patients aged 18 to 80 years (inclusive of 18 and 80 years), regardless of gender;
3. Patients who meet the diagnostic criteria for anterior cruciate ligament (ACL) tear and have no contraindications for implantation;
4. Patients with mature skeletons;
5. Good compliance and willingness and ability to participate in follow-up observations as required.
Exclusion Criteria:
* (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.
Primary outcome measure(s)
Evaluation of Bone Tunnel Footprint Localization Accuracy — 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
Trial sites (1)
Facility
City
Region
Status
Beijing Tsinghua Chang Gung Hospital.
Beijing
Beijing Municipality
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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