LIVing Donor Allograft for Anterior Cruciate Ligament Reconstruction Study

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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