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

Launched by BEIJING TSINGHUA CHANG GUNG HOSPITAL · Feb 28, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new surgical robot designed to improve the accuracy of anterior cruciate ligament (ACL) reconstruction surgery. The robot features a preoperative navigation system, which helps doctors place bone tunnels more precisely during the procedure. This study aims to see if using this advanced technology leads to better surgical outcomes and fewer complications for patients undergoing ACL surgery. The research is being conducted at multiple centers in China and is led by Professor Yu Jiakuo from Tsinghua University.

To participate in this trial, individuals must be between 18 and 80 years old and have a diagnosed ACL tear. They should also be in good health and willing to follow the study's guidelines and follow-up requirements. However, certain conditions may exclude someone from participating, such as severe obesity, active infections, or other serious health issues. Participants can expect to receive care and support throughout the study, and their experiences will help determine the effectiveness of this innovative surgical technology in enhancing ACL surgery outcomes.

Gender

ALL

Eligibility criteria

• 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.