Degradable magnesium interfacial screws are used for fixation of bone-patellar tendine-bone or soft tissue grafts during anterior/posterior cruciate ligament (ACL/PCL) reconstruction
Conditions
Interventions
Experimental group:Study participants performed anterior/posterior cruciate ligament (ACL/PCL) reconstruction surgery using degradable magnesium interface screws manufactured by Dongguan Yi'an Technol
Control group:Study participants underwent anterior/posterior cruciate ligament (ACL/PCL) reconstruction surgery using polyetheretherketone interface screws manufactured by Xerox Hui Inc. in the Unite
Sponsors
Peking Union Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Age>=18 years and <=60 years, BMI.=18kg/m^2 and <=35kg/m^2, gender is not limited; 2. Unilateral knee joint confirmed anterior/posterior cruciate ligament (ACL/PCL) rupture/tear by MRI examination, and anterior cruciate ligament (ACL) or posterior cruciate ligament (PCL) reconstruction surgery is planned; 3. The subject and/or his/her guardian can understand the purpose of the trial, show adequate compliance with the trial protocol, and sign the informed consent form;
Exclusion criteria
Exclusion criteria: 1. Ruptured or injured medial and lateral collateral ligaments of the affected knee require surgical treatment; 2. Confirmed fracture of the affected lower limb with concomitant fracture, internal fixation of fracture that has not been removed, history of surgery of the affected knee or osteoarthritis of the knee joint Grade II or above; 3. Severe osteoporosis that may affect surgery or implant fixation as judged by the investigator; 4. Combined with confirmed epilepsy, severe heart, liver, lung, renal failure, severe thyroid dysfunction, severe neurological disease, severe cardiovascular disease, severe soft tissue injury at the proposed operation, malignant tumor, systemic infection or uncontrolled local infection; 5. History of allergy to implanted materials; 6. Contraindications to MRI examination (such as history of vascular stent implantation that does not tolerate MRI examination, cardiac pacemaker implantation that does not tolerate MRI examination and has not been removed, etc.); 7. Proposed use of systemic glucocorticoids or magnesium-containing preparations (such as magnesium aluminum carbonate) for a long time (daily use and continuous use >=1 month) due to underlying diseases; 8. Blood creatinine> 2.0 mg/dL or blood magnesium > 1.50 mmol/L; 9. Fasting blood glucose value>=10.0mmol/L; 10. Severe coagulopathy (PT or APTT>=2 times the upper limit of normal); 11. Pregnant or lactating females; 12. Participation in other interventional clinical trials within 1 month prior to enrollment; 13. Other situations in which the investigator believes that they should not participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lysholm score 24 weeks after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Lysholm score improvement level;Lysholm scores 12 and 52 weeks after surgery;Good Lysholm score rate at 12, 24 and 52 weeks after surgery;IKDC scores at 12, 24 and 52 weeks after surgery;Positive rate of Lachman test;Drawer test positive rate;Positive rate of axial shift test;Evaluation of instrument performance; | — |
Countries
China
Contacts
Public ContactYang Bo
Peking Union Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed