LIVing Donor Allograft for Anterior Cruciate Ligament Reconstruction Study

NCT05395767 | Recruiting DMC

• 1 other identifier: MaidstoneNHS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

ACL

Outcome Measures

Primary Outcomes (8)

• 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).

  6 weeks post op

• 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).

  6 months post op

• International Knee Documentation Committee Subjective Knee Form (IKDC)

  Evaluates symptoms, daily activity and sports function

  1 year post op

• 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).

  2 years post op

• Tegner Lysholm

  Symptom reporting questionnaire made up of two components. The Lysholm score Scores range from 0 (worse disability) to 100 (less disability) and the Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer.

  6 weeks post op

• Tegner Lysholm

  Symptom reporting questionnaire made up of two components. The Lysholm score Scores range from 0 (worse disability) to 100 (less disability) and the Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer.

  6 months post op

• Tegner Lysholm

  Symptom reporting questionnaire made up of two components. The Lysholm score Scores range from 0 (worse disability) to 100 (less disability) and the Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer.

  1 year post op

• Tegner Lysholm

  Symptom reporting questionnaire made up of two components. The Lysholm score Scores range from 0 (worse disability) to 100 (less disability) and the Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer.

  2 years post op

Secondary Outcomes (9)

• KT 1000

  1 year post op

• KT 1000

  2 years post op

• return to sport questionnaire

  1 year post op

• return to sport questionnaire

  2 years post op

• hop test

  1 year post op

Study Arms (1)

endoscopic ACL reconstruction with parent allograft tendon

EXPERIMENTAL

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

Interventions

Endoscopic Anterior Cruciate Ligament reconstruction using living donor hamstring allograft from a parent donor PROCEDURE

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.

endoscopic ACL reconstruction with parent allograft tendon

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Maidstone & Tunbridge Wells NHS Trust: lead

Study Sites (1)

Trauma & Orthopaedic Dept, Tunbridge Wells Hospital

Pembury, Kent, TN2 4QJ, United Kingdom

RECRUITING

Study Officials

• Nicholas Bowman

  Maidstone & Tunbridge Wells NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helen Sankey, MSc

CONTACT

01892 635488; h.sankey@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cohort Study

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: May 27, 2022
• Study Start: September 15, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2028
• Last Updated: May 23, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)