NCT05395767 LIVing Donor Allograft for Anterior Cruciate Ligament Reconstruction Study
| NCT ID | NCT05395767 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Maidstone & Tunbridge Wells NHS Trust |
| Condition | ACL |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2021-09-15 |
| Primary Completion | 2026-09 |
Trial Parameters
Eligibility Fast-Check
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Brief 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
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 surger