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 @ 1:59 PM
Ignite Modification Date:
2025-12-24 @ 1:59 PM
NCT ID:
NCT03441295
Eligibility Criteria:
Inclusion Criteria:
* • Primary acute proximal ACL rupture (MRI and per-operative confirmation): 3-digit ACL rupture classification, type A (supplement 1)
* Between 18-50 years, male or female
* Randomization and surgery within 4 weeks after the ACL rupture (Study 1)
* Randomization and surgery between 5-12 weeks after the ACL rupture (Study 2)
* The ACL remnant is suitable for repair in the three treatment groups: the distal ACL remnant must be in contact with the proximal remnant/femoral condyle for at least 75% (per-operative confirmation)
* The patient is mentally and verbally capable of participating in the study.
* Written informed consent (according to the International Conference on Harmonisation (ICH)-GCP Guidelines).
Exclusion Criteria:
* • Known posterior cruciate ligament (PCL) and/or posterolateral ligamentous complex (PLC), lateral collateral ligament (LCL) or medial collateral ligament (MCL) grade 3 injury.
* Known osseous fractures that could impair revalidation and/or ACL repair
* Patients with neurological disorders or systemic diseases
* Patients with trauma/fractures in the lower limb in the past 6 months that could influence rehabilitation
* Non-sportive patients with a Tegner score of \<3: these patients could probably counteract instability complaints with intensive physiotherapy.
* Any inflammatory disease, Rheumatoid Arthritis (RA), Spondyloarthropathy (SpA), active malignancy
* Patient not suited for intervention due to lack of mobility, meaning not achieving 90° of flexion before surgery.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT03441295
Study Brief:
Protocol Section:
NCT03441295