Actively Recruiting
A Prospective Study of ACL Reconstruction in Children Using Living Donor Hamstring Allograft from a Parent
Led by Maidstone & Tunbridge Wells NHS Trust · Updated on 2025-05-23
40
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a new approach to reconstruct the Anterior Cruciate Ligament (ACL) in children and young patients aged 8 to 17 years who have experienced an ACL rupture. This condition is increasingly identified in this age group, and surgery is usually recommended. The study evaluates a technique using hamstring tendons donated by a living adult donor, often a parent, instead of the child's own tendons or tendons from deceased donors, aiming to address challenges with graft size and durability in younger patients. The procedure involves the adult donor undergoing hamstring tendon removal under general anesthesia, while the child is prepared for ACL reconstruction surgery. The harvested graft is then implanted into the child using standard surgical methods. Patients will be followed for two years or until they reach skeletal maturity. Rehabilitation follows established pediatric guidelines, and patients will have regular clinical reviews and assessments throughout the study period. Participants will attend scheduled visits for subjective and objective knee assessments, including questionnaires and instrumented testing. Researchers will monitor outcomes such as knee function and stability at multiple intervals up to two years after surgery. Any adverse events will be reported according to regulatory requirements. The total participation time includes the surgery and follow-up visits over the two years or until skeletal maturity, whichever is later.
CONDITIONS
Brief Title
LIVing Donor Allograft for Anterior Cruciate Ligament Reconstruction Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 8 to 17 years inclusive with a clinically and radiologically confirmed ACL rupture needing reconstruction
- Patients with previous or current meniscal pathology
- Child and responsible adult agree to undergo ACL reconstruction using living donor allograft
- Donor has not had previous tendon harvest on the donor limb
- Patients willing to attend follow-up appointments and complete knee questionnaires and instrumented knee ligament testing
You will not qualify if you...
- Patients who had previous ACL surgery on the same knee requiring revision surgery
- Patients who are immunosuppressed or receiving immunosuppressive therapy
- Patients unable to attend follow-up appointments for research purposes
- Donors with prior hamstring tendon surgery on the donor limb
- Patients and donors with positive screening for transmissible infections
- Donors with risk factors for transmissible infection based on questionnaire
- Donors not healthy enough for tenotomy under general anesthesia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo ACL reconstruction surgery using a living donor hamstring allograft from a parent donor, including donor hamstring tendon harvest and child recipient ACL reconstruction.
1 surgery visit (in-person)
Duration - Up to 2 years or until skeletal maturity, whichever is later
Participants follow standard paediatric rehabilitation guidelines and attend scheduled clinical reviews for subjective and objective knee assessments.
Multiple follow-up visits at 6 weeks, 6 months, 1 year, and 2 years post-operation
Trial Site Locations
Total: 1 location
1
Trauma & Orthopaedic Dept, Tunbridge Wells Hospital
Pembury, Kent, United Kingdom, TN2 4QJ
Actively Recruiting
Research Team
H
Helen Sankey, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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