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:
2025-12-25 @ 12:30 AM
Ignite Modification Date:
2025-12-25 @ 12:30 AM
NCT ID:
NCT05395767
Eligibility Criteria:
Inclusion Criteria:
* Patients aged 8 to 17 years inclusive and have a clinically and radiologically confirmed ACL rupture that requires reconstruction.
* Patients who have had previous surgery for meniscal pathology .
* Patients with current meniscal pathology
* The child and their responsible adult are in agreement with the choice to undergo anterior cruciate ligament reconstruction using living donor allograft.
* Donors has not previously undergone tendon harvest on the chosen donor limb
* Patients are willing to attend follow up appointments and agree to fill in knee questionnaires and allow instrumented knee ligament testing.
Exclusion Criteria:
* Patients who have previously undergone ACL surgery on the same limb (and therefore require revision surgery)
* Patients who are immunosuppressed, or receiving immunosuppressive therapy
* Patients who are unable to attend follow-up appointments for continued research purposes.
* Donors who have previously undergone hamstring tendon surgery on the donor limb
* Patients and donors who have a positive screening blood test for any of the transmissible infections tested
* Donors whose answers to the 'Donor Documentation Questionnaire' indicate that there could be a risk of transmissible infection, may not included
* Donors who are not considered healthy enough to undergo a tenotomy under General anaesthetic
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
17 Years
Study:
NCT05395767
Study Brief:
Protocol Section:
NCT05395767