NCT05584020 Arthroscopic Anterior Cruciate Ligament Repair Versus Reconstruction for Acute Anterior Cruciate Ligament Injury
| NCT ID | NCT05584020 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine |
| Condition | Anterior Cruciate Ligament Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2022-11-18 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 140 participants in total. It began in 2022-11-18 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Background: Arthroscopic anterior cruciate ligament(ACL) reconstruction is so far the gold standard for the treatment of ACL ruptures, but this technique still suffers from problems of tendon-bone healing, bone tunnel enlargement, bone resorption, a low rate of return to motion,etc. In recent years, due to the innovation of medical materials and surgical techniques, anterior cruciate ligament repair technology has returned to the field of vision of clinical doctors. This technique has the advantages of preserving the natural ligaments and their proprioceptive sensation, avoiding the bone injury of the tunnel and the complications of the donor site. However, there is still a lack of high-quality clinical randomized controlled trails to provide evidence of the effect of arthroscopic ACL repair. Hypothesis: Arthroscopic ACL repair is comparable to ACL reconstruction in patients with ACL tears (Sherman grades I and II). Study Design: This study was a prospective, multicenter, randomized, double-blinded, parallel-controlled, non-inferiority trial design. A total of 330 patients with ACL tears were randomly divided into 2 groups, and were randomly assigned to the experimental group (arthroscopic anterior cruciate ligament repair) and the control group (arthroscopic anterior cruciate ligament reconstruction) according to 1:1. Follow-up knee function and other scores were performed at 3 months, 6 months, 1 year, and 2 years after surgery, and the total study time is expected to be 3 years.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05584020 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Anterior Cruciate Ligament Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05584020 currently recruiting?
Yes, NCT05584020 is actively recruiting participants. Contact the research team at daixshz@163.com for enrollment information.
Where is the NCT05584020 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT05584020 clinical trial?
NCT05584020 is sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. The trial plans to enroll 140 participants.