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

Overview

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.

Interventions

• Procedure Endoscopic Anterior Cruciate Ligament reconstruction using living donor hamstring allograft from a parent donor
  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.

Primary outcome measures

• International Knee Documentation Committee Subjective Knee Form (IKDC) [Time frame: 6 weeks post op]
• International Knee Documentation Committee Subjective Knee Form (IKDC) [Time frame: 6 months post op]
• International Knee Documentation Committee Subjective Knee Form (IKDC) [Time frame: 1 year post op]
• International Knee Documentation Committee Subjective Knee Form (IKDC) [Time frame: 2 years post op]
• Tegner Lysholm [Time frame: 6 weeks post op]
• Tegner Lysholm [Time frame: 6 months post op]
• Tegner Lysholm [Time frame: 1 year post op]
• Tegner Lysholm [Time frame: 2 years post op]

Secondary outcome measures (9)

• KT 1000 [Time frame: 1 year post op]
• KT 1000 [Time frame: 2 years post op]
• return to sport questionnaire [Time frame: 1 year post op]
• return to sport questionnaire [Time frame: 2 years post op]
• hop test [Time frame: 1 year post op]
• hop test [Time frame: 2 years post op]
• squat test [Time frame: 6 months post op]
• squat test [Time frame: 1 year post op]
• squat test [Time frame: 2 years post op]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United Kingdom · 1 center

• Trauma & Orthopaedic Dept, Tunbridge Wells Hospital — Pembury

Identifiers

NCT: NCT05395767 · MaidstoneNHS

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗