Using living donor hamstring tendons for ACL reconstruction in children
A Prospective Cohort Study of Skeletally Immature Patients Requiring Endoscopic Anterior Cruciate Ligament Reconstruction, Using Living Donor Hamstring Allograft From a Parent
This study is testing a new way to repair torn ACLs in kids by using hamstring tendons from a living parent to see if it helps them heal better than traditional methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 8 Years to 17 Years |
| Sex | All |
| Sponsor | Maidstone & Tunbridge Wells NHS Trust Academic / other |
| Locations | 1 site (Pembury, Kent) |
| Trial ID | NCT05395767 on ClinicalTrials.gov |
What this trial studies
This study focuses on reconstructing the Anterior Cruciate Ligament (ACL) in children aged 8 to 17 years who have suffered a rupture. It employs a novel technique where hamstring tendons are harvested from a living donor, typically a parent, and then implanted into the child. The study aims to address the challenges of using traditional grafts in skeletally immature patients, who often have smaller tendons. By utilizing living donor tendons, the researchers hope to improve outcomes and reduce the rerupture rates associated with allografts from deceased donors.
Who should consider this trial
Good fit: Ideal candidates are children aged 8 to 17 years with a confirmed ACL rupture requiring reconstruction.
Not a fit: Patients who have previously undergone ACL surgery on the same limb or are immunosuppressed may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better surgical outcomes and lower rerupture rates for children undergoing ACL reconstruction.
How similar studies have performed: While the use of living donor tendons is less common, similar approaches have shown promise in other studies, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Pembury, Kent
- Trauma & Orthopaedic Dept, Tunbridge Wells Hospital — Pembury, Kent, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Nicholas Bowman — Maidstone & Tunbridge Wells NHS Trust
- Study coordinator: Helen Sankey, MSc
- Email: h.sankey@nhs.net
- Phone: 01892 635488
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.