Meniscus Injury Clinical Trial
Official title:
Meniscus Repair With Simultaneous ACL Reconstruction: Clinical Outcomes,Failure Rates And Subsequent Processing
| NCT number | NCT04455516 |
| Other study ID # | M2020024 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 16, 2020 |
| Est. completion date | May 16, 2020 |
| Verified date | July 2020 |
| Source | Peking University Third Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Our study has explored the causes of failure of meniscus repair and investigated the clinical effects of partial meniscectomy when meniscus repair failed.
| Status | Completed |
| Enrollment | 165 |
| Est. completion date | May 16, 2020 |
| Est. primary completion date | April 16, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 13 Years to 60 Years |
| Eligibility |
Inclusion Criteria: 1. patients with intraoperatively confirmed ACL rupture combined with medial, lateral, or medial and lateral meniscal injury; 2. age <60 years 3. no history of previous ipsilateral knee meniscal injury. Exclusion Criteria: 1. ACL rupture associated with fracture, collateral ligament injury, or complex ligament injury; 2. a history of knee surgery; 3. a significant degree of osteoarthritis. |
| Country | Name | City | State |
|---|---|---|---|
| China | Peking University Third Hospital | Beijing | Beijing |
| Lead Sponsor | Collaborator |
|---|---|
| Peking University Third Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The result of partial meniscus resection | Clinical signs were assessed after the surgery, including swelling of the joint, tenderness at the joint line, locked-in syndrome, and positive McMurray's sign. | Two years after the surgery | |
| Primary | International Knee Documentation Committee(IKDC)scores | The minimum is 0, the maximum is 100, and the higher the score, the better the result | Two years after the surgery | |
| Primary | Visual analog scale (VAS) scores | The minimum is 0, the maximum is 10, and the higher the score, the worse the result | Two years after the surgery | |
| Primary | Lysholm scores | The minimum is 0, the maximum is 100, and the higher the score, the better the result | Two years after the surgery |
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