Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2025-12-24 @ 2:31 PM
NCT ID:
NCT06899659
Eligibility Criteria:
Inclusion Criteria:
* Age between 18 and 60 years
* Scheduled for meniscal repair with a vertical longitudinal full-thickness tear (e.g., bucket-handle) in the red-red and red-white zones
* Able to understand all risks and benefits described in the informed consent form and willing to comply with the rehabilitation and follow-up visits specified in the clinical trial protocol
Exclusion Criteria:
* Meniscal tears in the avascular zone of the meniscus
* Meniscal tears not suitable for repair due to the degree of damage (marked irregularity and complex tearing) to the meniscus body, including degenerative, radial, horizontal cleavage, flap, and root tears
* Multiple ligament injuries of the affected knee joint
* Adhesion of the affected knee joint
* Planned intraoperative or postoperative intra-articular injection
* Articular surface cartilage injury of the targeted knee assessed by the - International Cartilage Repair Society (ICRS) is grade 3-4 Kellgren-Lawrence grades of documented radiographic evidence of osteoarthritis (OA) in the affected knee is ≥III
* Instability or valgus/varus deformity (\>5°) of the affected knee
* Acute or chronic, local or systemic infections
* Metabolic diseases
* Abnormal liver and kidney function (creatinine 3 times higher than the upper limit of normal value or alanine aminotransferase or aspartate aminotransferase 3 times higher than the upper limit of normal value) before operation
* History of operation in the affected knee
* Acute myocardial infarction or stroke occurred within 6 months before operation
* Known allergy to any material (polyethylene, polypropylene, polyester, polyetheretherketone) of the implants
* Pregnant or known to be pregnant
* Other circumstances that the researchers believe may affect the efficacy and safety evaluation of the investigated medical devices
* Currently participating in other clinical trials
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06899659
Study Brief:
Protocol Section:
NCT06899659