anterior cruciate ligament rupture
Conditions
Interventions
1:Naton Absorbable Interface Screws/Available Absorbable Interface Screws
2:Use absorbable nails (Inion Oy, INION, Finland)
Sponsors
Natong Biotechnology (Beijing)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. The subject or guardian is willing and able to sign the informed consent before operation; 2. Patients aged from 18 to 80 years (including 18 and 80 years), regardless of gender; 3. Patients who meet the diagnostic criteria for anterior cruciate ligament rupture of the knee joint and have no contraindications for implantation; 4. The patient's skeleton is mature; 5. Good compliance, willing and able to conduct follow-up observation as required.
Exclusion criteria
Exclusion criteria: 1. Subjects who have participated in clinical studies of other drugs, biological agents or medical devices before enrollment and have not reached the main end point of the study; 2. The patient is known to have a history of allergy to one or more implant materials; 3. Those who are physically weak or unable to tolerate surgery due to other diseases; 4. Active infection of knee joint or other parts of the body; 5. The affected knee joint has other ligament injuries and/or meniscus injuries; 6. The ipsilateral knee joint needs meniscus repair and other operations at the same time; 7. Obesity BMI>35; 8. Patients with severe diabetes (For acute complications of diabetes, preoperative random blood glucose = 16.7mmol/L is accompanied by or accompanied by consciousness disorders, such as diabetes ketosis, suspected diabetes ketoacidosis, hyperglycemia hyperosmotic state or lactic acid acidosis; chronic diabetes complications lead to acute cardiovascular and cerebrovascular diseases, renal dysfunction, severe vision loss caused by retinopathy, intermittent claudication and ischemic symptoms caused by peripheral vascular diseases, diabetes foot, etc., which need emergency Serious target organ damage treated); 9. Breastfeeding and pregnant women; 10. Drug users and drug users *; 11. The patient is mentally incapacitated or unable to understand the requirements for participating in the study and is difficult to cooperate; 12. Poor expected compliance, unwilling or unable to follow the instructions of postoperative treatment and/or rehabilitation plan; 13. Other diseases combined with the subjects restrict their participation in the study, fail to follow up or affect the scientific integrity of the study; 14. Other situations judged by the researcher as inappropriate for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lysholm score; | — |
Secondary
| Measure | Time frame |
|---|---|
| The upper, middle and lower diameters of the tibial bone tunnel;Relative tibial anterior displacement;Knee ROM;IKDC score;Tegner score; | — |
Countries
China
Contacts
Public ContactYu Jiakkuo
Institute of Sports Medicine/Department of Sports Medicine, Peking University Third Hospital
Outcome results
None listed