Anterior Cruciate Ligament Tear
Conditions
Interventions
Experimental Group:Robotic arm positioning under robotic navigation.
Control Group:Manual positioning after traditional arthroscopic navigation.
Sponsors
Beijing Tsinghua Changgung Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Preoperatively, the participant or their guardian is willing and able to sign the informed consent form. 2. Patients aged 18 to 80 years (inclusive), regardless of gender. 3. Patients who meet the diagnostic criteria for anterior cruciate ligament (ACL) rupture and have no contraindications for implantation. 4. Patients with mature bones. 5. Patients who are compliant and willing and able to follow the required follow-up observations.
Exclusion criteria
Exclusion criteria: 1. Participants who have previously participated in other drug, biologic, or medical device clinical studies and have not reached the primary endpoint duration. 2. Patients with a known history of allergy to one or more of the implant materials. 3. Patients who are physically frail or have other systemic diseases that make them unable to tolerate surgery. 4. Patients with active infection foci in the knee joint or other parts of the body. 5. Patients with obesity (BMI > 35). 6. Patients with severe diabetes (acute complications, preoperative random blood glucose >= 16.7 mmol/L with or without altered mental status, such as diabetic ketoacidosis, suspected diabetic ketoacidosis, hyperosmolar hyperglycemic state, or lactic acidosis; chronic complications causing severe target organ damage requiring urgent treatment, such as acute cardiovascular or cerebrovascular diseases, renal insufficiency, retinopathy leading to severe vision loss, peripheral vascular disease causing intermittent claudication and ischemic symptoms, diabetic foot). 7. Nursing or pregnant women. 8. Drug users and substance abusers. 9. Patients who are mentally incapable or unable to understand the requirements of the study and are difficult to cooperate with. 10. Patients with poor expected compliance, unwilling or unable to follow the postoperative therapy and/or rehabilitation instructions. 11. Patients with other concurrent diseases that limit their participation in the study, prevent them from adhering to follow-up, or affect the scientific integrity of the study. 12. Other conditions deemed by the investigator as unsuitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of Footprint Site Localization;Knee Flexion and Extension Angle;International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form;Tegner Activity Scale for Knee Function;Visual Analogue Scale (VAS Score); | — |
Secondary
| Measure | Time frame |
|---|---|
| Lyshom score;Relative Anterior Tibial Translation Distance; | — |
Countries
China
Contacts
Public ContactYu Jiakuo
Beijing Tsinghua Changgung Hospital
Outcome results
None listed