Status:
RECRUITING
LIVing Donor Allograft for Anterior Cruciate Ligament Reconstruction Study
Lead Sponsor:
Maidstone & Tunbridge Wells NHS Trust
Conditions:
ACL
Eligibility:
All Genders
8-17 years
Phase:
NA
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 patient...
Detailed Description
The Anterior Cruciate Ligament (ACL) is a major stabiliser of the knee. ACL rupture is being increasingly identified in children and skeletally immature patients. Following rupture of this ligament, t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05395767
Start Date
September 15 2021
End Date
September 1 2028
Last Update
May 23 2025
Active Locations (1)
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1
Trauma & Orthopaedic Dept, Tunbridge Wells Hospital
Pembury, Kent, United Kingdom, TN2 4QJ