Tear of the anterior cruciate ligament (ACL)
Conditions
Interventions
Intervention Group:3D-printed guide plate-assisted ACL reconstruction
Control group:Conventional ACL reconstruction with standard tunnel positioning
Sponsors
The First Affiliated Hospital of Hainan Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-45 years (inclusive): This range covers active young people who usually require ACL reconstruction, while excluding children and elderly patients who may have osteoarthritis. 2. Acute traumatic ACL rupture confirmed by clinical examination (positive Lachman test and pivot shift test) and MRI. "Acute" is defined as injury within 3 months. 3. Primary single-bundle ACL reconstruction with autologous hamstring tendon is determined by an orthopedic surgeon. 4. The affected knee has no history of ACL reconstruction or major surgery (i.e., this is the first time the knee has undergone ACL reconstruction). 5. Acceptable preoperative knee CT scan planning (no CT contraindications, pregnancy exclusion criteria see below). 6. The patient signed a written informed consent (if subjects aged 16-17 are included, guardian consent is required, but this study is mainly for adults aged >=18 years). 7. Willing and able to cooperate with the research process, rehabilitation program and 1-year follow-up.
Exclusion criteria
Exclusion criteria: 1. Multi-ligament knee injuries requiring additional surgery (e.g., combined Grade III MCL or PCL injuries requiring reconstruction). Minor combined injuries such as meniscal tears are not excluded (meniscal repair or debridement can be performed at the same time), but complex knee dislocations are excluded. 2. Moderate to severe knee osteoarthritis or bone deformity that may affect tunnel positioning (such as malalignment that usually requires osteotomy). 3. Chronic ACL injuries (injury > 6 months) or poor tissue quality require consideration of primary repair tears (rare in this age group). This study focuses on acute/recent injuries. 4. Previous knee surgery that may interfere with guide plate placement or confound the results (such as previous ACL reconstruction, tibial plateau fracture internal fixation). 5. Contraindications for CT scanning (e.g., pregnant women are excluded due to radiation exposure; Note: CT scanning in this study usually does not require contrast agents, so it is not suitable for those who are allergic to contrast agents). 6. Systemic diseases that are contraindications to surgery/anesthesia (such as uncontrolled diabetes, active infection, coagulation disorders) or conditions that affect recovery (such as severe neurological deficits). 7. BMI > 35 (morbidly obese), as excess fat may interfere with the precise fit of the guide or alter the surgical technique (this threshold is somewhat subjective and primarily considers extreme anatomical variations). 8. Refusal or inability to sign informed consent/comply with follow-up schedule.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IKDC Subjective knee Joint score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient-Reported Outcomes;Objective knee stability index;Functional testing;Imaging and surgical technical indicators; | — |
Countries
China
Contacts
Public ContactBingshen Jia
The First Affiliated Hospital of Hainan Medical University
Outcome results
None listed