Anterior Cruciate Ligament injury of the knee
Conditions
Interventions
Tension-Relieving Augmentation Reconstruction Group:To perform arthroscopic anatomical ACL reconstruction by weaving a Novel Internal Tension-Relieving Augmentation System into the tendon graft
Sponsors
First Affiliated Hospital of Kunming Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1.Male or female, aged 18 to 50 years inclusive. 2.Meet the diagnostic criteria for ACL injury as outlined in the 2021 International Consensus on Anterior Cruciate Ligament Injuries (ICON). 3.Anterior cruciate ligament (ACL) injury of the knee associated with meniscal injury. 4.Patients who are scheduled for arthroscopic anatomical anterior cruciate ligament reconstruction. 5.The patient is generally healthy, has no significant chronic medical history, and is considered able to tolerate the surgical procedure. 6.There are no extra-articular comorbidities or joint deformities. 7.Adult subjects have consented to participate in this trial and have signed the Informed Consent Form. 8.Is willing to comply with all prohibitions and restrictions specified in this study protocol. 9.The patient participated voluntarily, provided signed informed consent, and demonstrated good compliance
Exclusion criteria
Exclusion criteria: 1.including knee joint infection, gouty arthritis, or rheumatoid arthritis. 2.Presence of knee stiffness or ankylosis. 3.With severe coagulopathy and/or bleeding disorders; 4.With severe osteoporosis; 5.concomitant neurological injury or severe muscle atrophy around the knee **were excluded; 6.With concomitant fracture and/or severe chondral lesion. 7.Multiple ligament injury of the knee. 8.Significant comorbidities (e.g., CAD, hypertension, diabetes, gout) that would preclude safe surgery. 9.Subjects with incomplete follow-up or those lost to follow-up; 10.Patients who have undergone open knee surgery within the past 6 months. 11.Pregnant or lactating women, women planning pregnancy, or those with a positive baseline pregnancy test. 12.Patients with underlying infectious, inflammatory, or metabolic arthritis of the knee; 13.Concurrent participation in another trial within the last 3 months or premature discontinuation from a prior trial; 14.Other conditions that make the subject ineligible for participation at the investigator’s discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| International Knee Documentation Committee Evaluation Form;Knee joint magnetic resonance imaging data; | — |
Secondary
| Measure | Time frame |
|---|---|
| Lysholm Knee Function Score;Pain Visual Analogue Scale;Post-Ligament Reconstruction of Anterior Cruciate Ligament Return to Sports Survey;Tegner Knee Joint Movement Score; | — |
Countries
China
Contacts
Public ContactYanlin Li
The First Affiliated Hospital of Kunming Medical University
Outcome results
None listed