Anterior cruciate ligament rupture
Conditions
Interventions
Experimental group:Autogenous hamstring tendon combined with surgical biological patch single-bundle reconstruction treatment
Control Group:Reconstruction of a single bundle of autogenous hamstring tendon
Sponsors
Shanghai Pine&Power Biotech Co.,Ltd
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Aged from 18 to 50 years, male or female; 2. A diagnosis of unilateral anterior cruciate ligament rupture with trauma history, Lachman test, axial shift test and MRI examination; 3. Able to understand the purpose of the trial, willing to cooperate with surgical treatment and follow-ups, voluntarily to participate in the trial and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Anterior cruciate ligament revision surgery; 2. With other ligament injuries (posterior cruciate ligament, medial and or lateral collateral ligament injuries); 3. With neuromuscular insufficiency disease(for example, paralysis, myolysis, or muscle weakness) that can lead to postoperative knee instability or abnormal gait; 4. A history of knee surgery; 5. Active infection lesions in the knee joint or other parts of the body; 6. Severe osteoporosis, metabolic bone disease, radiation bone disease, and tumor around the knee joint; 7. A clear history of allergies to the experimental materials (PLCL, fibrinogen); 8. Contraindications to surgery or anesthesia; 9. Participating in other interventional clinical trials; 10. Other factors that are not suitable for this trial judged by investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The excellent and good rate of Lysholm score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Surgical success rate;Lysholm score;IKDC score;Graft maturity;Lachman test classification;Axial shift test classification; | — |
Countries
China
Contacts
Public ContactZhao Jinzhong
Shanghai Sixth People's Hospital
Outcome results
None listed