ACLLivD_ACLRNCT05395767
LIVing Donor Allograft for Anterior Cruciate Ligament Reconstruction Study
A study testing Endoscopic Anterior Cruciate Ligament reconstruction using living donor hamstring allograft from a parent donor in people with ACL, run by Maidstone & Tunbridge Wells NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- ACL
- What is being tested?
- Endoscopic Anterior Cruciate Ligament reconstruction using living donor hamstring allograft from a parent donor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Sep 2021to Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Trauma & Orthopaedic Dept, Tunbridge Wells Hospital
Pembury, Kent, TN2 4QJ
Helen Sankey, MSc, 01892 635488, h.sankey@nhs.net
Nicholas Bowman, FRCS(ortho)
About this 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
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
Read the 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.
- Conditions
- ACL
- Being tested
- Endoscopic Anterior Cruciate Ligament reconstruction using living donor hamstring allograft from a parent donor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Anterior Cruciate Ligament reconstruction using living donor hamstring allograft from a parent donorProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| endoscopic ACL reconstruction with parent allograft tendon | Experimental | Not described Receives: Procedure: Endoscopic Anterior Cruciate Ligament reconstruction using living donor hamstring allograft from a parent donor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 6 months post op
International Knee Documentation Committee Subjective Knee Form (IKDC)
Evaluates symptoms, daily activity and sports function
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 years post op
Secondary outcomes (9)
KT 1000
instrumented laxity test
Measured: 1 year post op
KT 1000
instrumented laxity test
Measured: 2 years post op
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.
Measured: 1 year post op
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.
Measured: 2 years post op
hop test
functional test, In this test, the aim is to jump as far as possible on a single leg, without losing balance and landing firmly. The distance is measured from the start line to the heel of the landing leg. The goal is to have a less than 10% difference in hop distance between the injured limb and uninjured limb.
Measured: 1 year post op
hop test
functional test, In this test, the aim is to jump as far as possible on a single leg, without losing balance and landing firmly. The distance is measured from the start line to the heel of the landing leg. The goal is to have a less than 10% difference in hop distance between the injured limb and uninjured limb.
Measured: 2 years post op
squat test
functional test, scoring of the movement strategy occurring in individual body regions, where 0 for appropriate strategy and one for inappropriate movements, for each region with best overall score being 0 and worst 10 points
Measured: 6 months post op
squat test
functional test, scoring of the movement strategy occurring in individual body regions, where 0 for appropriate strategy and one for inappropriate movements, for each region with best overall score being 0 and worst 10 points
Measured: 1 year post op
squat test
functional test, scoring of the movement strategy occurring in individual body regions, where 0 for appropriate strategy and one for inappropriate movements, for each region with best overall score being 0 and worst 10 points
Measured: 2 years post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start15 Sep 2021
- Primary completionSep 2026 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cohort Study
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maidstone & Tunbridge Wells NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicholas Bowman, Principal investigator, Maidstone & Tunbridge Wells NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05395767
- Sponsor's protocol ID
- MaidstoneNHS
- Acronym
- LivD_ACLR
- Status last verified
- Jul 2026
- First submitted
- 2 Dec 2021
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study of Skeletally Immature Patients Requiring Endoscopic Anterior Cruciate Ligament Reconstruction, Using Living Donor Hamstring Allograft From a Parent
- ClinicalTrials.gov ID
- NCT05395767
- Acronym / sponsor ID
- LivD_ACLR / MaidstoneNHS
- Conditions
- ACL
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Maidstone & Tunbridge Wells NHS TrustUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 27 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cohort Study
| Arm | Type | Receives |
|---|---|---|
| endoscopic ACL reconstruction with parent allograft tendon | Experimental | Procedure: Endoscopic Anterior Cruciate Ligament reconstruction using living donor hamstring allograft from a parent donor |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic Anterior Cruciate Ligament reconstruction using living donor hamstring allograft from a parent donorThe 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. | Procedure or surgery | endoscopic ACL reconstruction with parent allograft tendon |
Primary outcome
International Knee Documentation Committee Subjective Knee Form (IKDC)
Time frame: 6 weeks post op
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).
International Knee Documentation Committee Subjective Knee Form (IKDC)
Time frame: 6 months post op
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).
International Knee Documentation Committee Subjective Knee Form (IKDC)
Time frame: 1 year post op
Evaluates symptoms, daily activity and sports function
International Knee Documentation Committee Subjective Knee Form (IKDC)
Time frame: 2 years post op
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).
Tegner Lysholm
Time frame: 6 weeks post op
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.
Tegner Lysholm
Time frame: 6 months post op
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.
Tegner Lysholm
Time frame: 1 year post op
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.
Tegner Lysholm
Time frame: 2 years post op
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.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for ACL
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Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicholas Bowman principal investigator
Maidstone & Tunbridge Wells NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Anterior Cruciate Ligament reconstruction using living donor hamstring allograft from a parent donor in people with ACL, run by Maidstone & Tunbridge Wells NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Helen Sankey, MSc (01892 635488, h.sankey@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Knee Documentation Committee Subjective Knee Form (IKDC) (time frame: 6 weeks post op). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.