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 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT05953051
Eligibility Criteria:
Inclusion Criteria:
* Age 18-50 years
* Primary ACL rupture
* Time from injury to surgery: 4 weeks to 6 months
* Single ACL rupture (isolated rupture)
* ACL surgery with one of the participating senior surgeons
* Informed Consent as documented by signature
Exclusion Criteria:
* Concomitant ligamentous instability/rupture
* Requirement for Meniscus suture (partial resection accepted, hoop and roots remain intact)
* Requirement for cartilage invasive treatment (debridement accepted)
* Osteoarthritis at index knee joint
* Leg axis deviation over 3° valgus or 4° varus
* Claustrophobia (contra-indication for the MRI)
* Women who are pregnant or breast feeding or intention to become pregnant during the study
* Known or suspected non-compliance, drug or alcohol abuse
* Inability of the patient to follow the study procedures, e.g. language problems, psychological disorders, dementia, etc.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT05953051
Study Brief:
Protocol Section:
NCT05953051