LIVing Donor Allograft for Anterior Cruciate Ligament Reconstruction Study (NCT05395767) | Clinical Trial Compass
RecruitingNot Applicable
LIVing Donor Allograft for Anterior Cruciate Ligament Reconstruction Study
United Kingdom40 participantsStarted 2021-09-15
Plain-language summary
The Anterior Cruciate Ligament (ACL) is a major stabiliser of the knee. ACL rupture is being increasingly identified in children and skeletally immature patients. The current advice in younger patients is usually to undergo ACL reconstruction. The choice of an ideal graft in children is difficult
This study will use a technique involves the use of hamstring tendons from a living donor, where the adult (usually a parent) agrees to donate their hamstring tendons, which are dissected out of them and implanted into the child
Who can participate
Age range
8 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
International Knee Documentation Committee Subjective Knee Form (IKDC)
Timeframe: 6 weeks post op
2
International Knee Documentation Committee Subjective Knee Form (IKDC)
Timeframe: 6 months post op
3
International Knee Documentation Committee Subjective Knee Form (IKDC)
Timeframe: 1 year post op
4
International Knee Documentation Committee Subjective Knee Form (IKDC)