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 @ 2:06 PM
Ignite Modification Date:
2025-12-24 @ 2:06 PM
NCT ID:
NCT03354195
Eligibility Criteria:
Inclusion Criteria:
Subjects must meet these criteria to participate in this study:
1. Patients with isolated, symptomatic femorotibial knee arthritis and candidates for UKA;
2. Patients ≥ 21 years old;
3. Patients with intact and non-functional ACLs as determined through pre-operative imaging, knee laxity tests, rotational stability tests, and intraoperative ACL classification;
4. Patients willing and able to sign an informed consent;
5. Patients willing and able to comply with 2-year follow-up commitments.
Exclusion Criteria:
Any subject who meets any of the exclusion criteria will be excluded from participation in this study:
1. Patients with RA;
2. Patients with BMI \>40;
3. Patients with ROM arc \> 75°;
4. Patients with greater than 10º of hyperextension;
5. Patients with greater than 15º of varus or valgus deformity;
6. Patients with active infection;
7. Patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis;
8. Patients without sufficient soft tissue integrity to provide adequate stability;
9. Patients with either mental or neuromuscular disorders that do not allow control of the knee joint;
10. Patients whose weight, age or activity level might cause extreme loads and early failure of the system.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
100 Years
Study:
NCT03354195
Study Brief:
Protocol Section:
NCT03354195