LIVing Donor Allograft for Anterior Cruciate Ligament Reconstruction Study
A Prospective Cohort Study of Skeletally Immature Patients Requiring Endoscopic Anterior Cruciate Ligament Reconstruction, Using Living Donor Hamstring Allograft From a Parent
Maidstone & Tunbridge Wells NHS Trust
40 participants
Sep 15, 2021
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria7
- 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
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Interventions
The Parent donor will undergo hamstring tendon graft harvest under general anaesthesia in a routine fashion in one theatre. The Graft material will be transported thorough to the adjacent theatre, where the child will be anaesthetised and undergoing arthroscopy of their injured knee in preparation for receiving the graft. ACL reconstruction Surgery will be undertaken in the child recipient as per the Surgeons usual technique, +/- meniscus repair +/- lateral tenodesis as required.
Locations(1)
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NCT05395767