Comparing ACL repair and reconstruction for knee injuries
Arthroscopic Anterior Cruciate Ligament Repair Versus Reconstruction for Acute Anterior Cruciate Ligament Injury: a Multicenter Randomized Controlled Surgical Trial
This study is testing whether a new way to fix knee ligament injuries can work as well as the standard surgery for people who hurt their ACL recently.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 330 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT05584020 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of arthroscopic anterior cruciate ligament (ACL) repair compared to the traditional ACL reconstruction in patients with acute ACL injuries. The study aims to determine if the repair technique, which preserves natural ligaments and reduces complications, is as effective as reconstruction. It involves a multicenter, randomized design with patients undergoing surgery within three weeks of their injury. The trial will provide high-quality evidence to guide treatment decisions for ACL injuries.
Who should consider this trial
Good fit: Ideal candidates are individuals with Sherman grade I or II ACL tears who are scheduled for surgery within three weeks of their injury.
Not a fit: Patients with additional knee injuries or systemic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a less invasive and more effective treatment option for patients with ACL injuries.
How similar studies have performed: While ACL reconstruction is the current standard, the repair technique is gaining attention, and this study aims to provide the first high-quality evidence for its effectiveness.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with anterior cruciate ligament tear clearly identified by imaging or intraoperative microscope, Sherman grade I, II; planned surgery within 3 weeks after injury 2. Basic reading and writing skills, and barrier-free communication 3. A smartphone, can use WeChat or be able to learn 4. Patients give informed consent, and sign the informed consent form, and the process must meet the requirements of GCP Exclusion Criteria: 1. Combined with other knee joint injuries (posterior cruciate ligament injury, patellar dislocation, osteoarthritis, etc.) 2. Suffering from systemic immune diseases; 3. Existing other knee joint diseases or inflammatory diseases, including osteoarthritis, cervical spine disease, rheumatoid arthritis, fibromyalgia, polymyalgia rheumatica, etc. 4. Patients who have received local hormone injection within 3 months; 5. Those who have participated in clinical trials or are undergoing other clinical trials within 3 months before screening 6. Those who have serious primary cardiovascular disease, lung disease, endocrine and metabolic disease or serious diseases that affect their survival, such as tumor or AIDS, the researchers believe that they are not suitable for selection 7. Patients with severe liver disease, kidney disease, and hematological disease, such as renal function exceeding the upper limit of the normal value, and liver function exceeding 2 times the upper limit of the normal value; 8. Suffering from viral hepatitis, infectious diseases, severe abnormal blood coagulation mechanism and other Diseases that the researchers consider inappropriate for surgery 9. Women who are pregnant or breastfeeding, or who plan to become pregnant during the follow-up period, those who have a positive urine human chorionic gonadotropin test result before sampling; menstruating women should wait until the end of menstruation before surgery; 10. Severe neurological and mental disorders Disease patients; 11. Suspected or actual history of alcohol and drug abuse.
Where this trial is running
Hangzhou, Zhejiang
- Second Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Xuesong Dai, Doctor
- Email: daixshz@163.com
- Phone: +8613777882818
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.