LIVing Donor Allograft for Anterior Cruciate Ligament Reconstruction Study
ConditionACL
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-17
SponsorMaidstone & Tunbridge Wells NHS Trust
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Endoscopic Anterior Cruciate Ligament reconstruction using living donor hamstring allograft from a parent donor
Procedure/SurgeryThe 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: endoscopic ACL reconstruction with parent allograft tendonExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
International Knee Documentation Committee Subjective Knee Form (IKDC)
Evaluates symptoms, daily activity and sports function. Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
Time frame
6 weeks post op2
International Knee Documentation Committee Subjective Knee Form (IKDC)
Evaluates symptoms, daily activity and sports function. Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
Time frame
6 months post op3
International Knee Documentation Committee Subjective Knee Form (IKDC)
Evaluates symptoms, daily activity and sports function
Time frame
1 year post op4
International Knee Documentation Committee Subjective Knee Form (IKDC)
Evaluates symptoms, daily activity and sports function. Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
Time frame
2 years post opSecondary outcomes
1
KT 1000
instrumented laxity test
Time frame
1 year post op2
KT 1000
instrumented laxity test
Time frame
2 years post op3
return to sport questionnaire
Psychological readiness for return to sport questionnaire, comprises 12 questions with a score of 1 to 10 for each. Where a lower score means a better outcome.
Time frame
1 year post op4
return to sport questionnaire
Psychological readiness for return to sport questionnaire, comprises 12 questions with a score of 1 to 10 for each. Where a lower score means a better outcome.
Time frame
2 years post opSponsors and contacts
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Source ClinicalTrials.gov