Using a robotic system to improve ACL surgery precision

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates a robotic system designed to enhance the accuracy of bone tunnel placement during anterior cruciate ligament (ACL) reconstruction surgery. The study employs a randomized controlled trial methodology to compare outcomes between surgeries performed with robotic assistance and those done manually. It aims to demonstrate the effectiveness of this innovative technology in improving surgical results and minimizing complications. Conducted across multiple centers in China, the trial is led by a prominent professor from Tsinghua University and has received necessary clinical registration.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beijing Tsinghua Chang Gung Hospital.
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Jiakuo Yu, Tenured professor at Tsinghua
• Email: yujiakuo@126.com
• Phone: +86 13331031448

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.