Assessing the Efficacy of a Preoperative Navigation System in Anterior Cruciate Ligament Reconstruction

Обзор

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.

Вмешательства

• Процедура 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.
• Процедура 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.

Первичные конечные точки

• Evaluation of Bone Tunnel Footprint Localization Accuracy [Срок оценки: One week post-surgery]

Вторичные конечные точки (6)

• Lysholm score [Срок оценки: At preoperative, 6 weeks postoperative, 3 months postoperative, 12 months, and 24 months.]
• Relative Anterior Translation of the Tibia [Срок оценки: At preoperative, 6 weeks postoperative, 3 months postoperative, 12 months, and 24 months.]
• Knee Flexion and Extension Angle (Range of Motion) [Срок оценки: At preoperative, 6 weeks postoperative, 3 months postoperative, 12 months, and 24 months.]
• International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC) [Срок оценки: At preoperative, 6 weeks postoperative, 3 months postoperative, 12 months, and 24 months.]
• Tegner Knee Activity Scale [Срок оценки: *At preoperative, 6 weeks postoperative, 3 months postoperative, 12 months, and 24 months.]
• Visual Analog Scale (VAS) Score [Срок оценки: At preoperative, 6 weeks postoperative, 3 months postoperative, 12 months, and 24 months.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• (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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing Tsinghua Chang Gung Hospital. — Пекин

Идентификаторы

NCT: NCT06858930 · 24751-0-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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