Brief Title
LIVing Donor Allograft for Anterior Cruciate Ligament Reconstruction Study
Official Title
A Prospective Cohort Study of Skeletally Immature Patients Requiring Endoscopic Anterior Cruciate Ligament Reconstruction, Using Living Donor Hamstring Allograft From a Parent
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
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, the current advice in younger patients is usually to undergo ACL
reconstruction. Different tissue or materials can be used to reconstruct the ligament. In the
majority of cases around the world, tendon material taken from somewhere else in the patient
is preferred, particularly the hamstring or patellar tendons.
The choice of an ideal graft in children is difficult. Patients who have not fully grown have
smaller tendons than adults, making them less suitable for use in reconstructive surgery.
Another option for children's reconstructions is allograft - tendons taken from another human
being. This has most commonly been from organ donation (taking tendons from a recently
deceased individual) however the rerupture rate of allograft has been shown to be higher than
in autograft (tendons taken from the patient themselves). The higher rate of rerupture may be
related to the sterilising and storage processes of the harvested tendons.
This study will use a technique used by a leading hospital in Sydney, Australia, that sees
and treats a large volume of these patients and has published good outcomes. The 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. The technique has the advantage of leaving the child's own tendons intact, and
having a larger sized tendon from a parent.
Patients & parents will be approached in clinic after MRI confirmation of an ACL rupture. If
all inclusion and exclusion criteria have been passed and they consent to participate,
screening documents & tests will be completed. The parent will undergo a hamstring tenotomy
whilst the child is prepped for ACL reconstruction, then the hamstring donor graft will be
inserted in the child patient, using the surgeon's routine fixation devices. All patients
will be assessed for skeletal maturity prior to surgery and will be followed up for two years
or until skeletal maturity, whichever happens latest. They will follow standard
rehabilitation guidelines for paediatric patients at Maidstone & Tunbridge Wells National
Health Service Trust (MTW NHS Trust) and be seen at set study intervals for clinical review,
subjective and objective assessment. Any adverse events will be reported to the health
regulation authority and Human Tissue Licence Authority.
Study Type
Interventional
Primary Outcome
International Knee Documentation Committee Subjective Knee Form (IKDC)
Secondary Outcome
KT 1000
Condition
ACL
Intervention
Endoscopic Anterior Cruciate Ligament reconstruction using living donor hamstring allograft from a parent donor
Study Arms / Comparison Groups
endoscopic ACL reconstruction with parent allograft tendon
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
10
Start Date
September 15, 2021
Completion Date
September 2028
Primary Completion Date
September 2024
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 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
Gender
All
Ages
8 Years - 17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Nicholas Bowman, 01892 635488, [email protected]
Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT05395767
Organization ID
MaidstoneNHS
Responsible Party
Sponsor
Study Sponsor
Maidstone & Tunbridge Wells NHS Trust
Study Sponsor
Nicholas Bowman, Principal Investigator, Maidstone & Tunbridge Wells NHS Trust
Verification Date
May 2022