Single versus double hamstring tendon graft in anterior cruciate ligament reconstruction in the paediatric patient: a single-blind randomised controlled trial study protocol

IntroductionThere is currently no clear indication in the literature regarding a single or double hamstring tendon (single bundle) autograft for anterior cruciate ligament (ACL) reconstruction in the paediatric patient. The primary aim of this single blind randomised controlled trial is to determine...

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Bibliographic Details
Published in:BMJ open 2022-08, Vol.12 (8), p.e057465-e057465
Main Authors: Bade, David, Malayko, Garrett, Johnson, Liam, Bradford, Kylie, Reddan, Tristan, Stockton, Chris, Frawley, Kieran, Phillips, Teresa, Saxby, David, Ware, Robert S, Byrnes, Joshua, Carty, Christopher P
Format: Article
Language:English
Subjects:
Adults
Arthritis
Joint and ligament injuries
Knee
Morphology
Orthopaedic sports trauma
Orthopedics
Osteoarthritis
Paediatric orthopaedic & trauma surgery
Paediatric orthopaedics
Patient satisfaction
Pediatrics
Sports and Exercise Medicine
Sports injuries
SPORTS MEDICINE
Surgeons
Surgery
Surgical techniques
Tendons
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Summary:IntroductionThere is currently no clear indication in the literature regarding a single or double hamstring tendon (single bundle) autograft for anterior cruciate ligament (ACL) reconstruction in the paediatric patient. The primary aim of this single blind randomised controlled trial is to determine whether a single or double hamstring tendon graft ACLR leads to superior clinical outcomes postsurgery in paediatric patients with ACL injury.Methods and analysisSingle site, prospective, single blind, randomised controlled trial with two parallel treatment arms. 100 patients aged 10–18 years who present with an isolated ACL tear±meniscal injury, verified on MRI, will be randomly allocated to one of the two surgical groups. The primary outcomes will be side-to-side difference in anterior tibial translation and graft failure incidence 12 months postsurgery. Primary and secondary outcomes will also be assessed at 2-year and 5-year postsurgery.Ethics and disseminationResults will be presented in peer-reviewed journals and at international conferences and disseminated to participants and healthcare professionals via newsletters and hospital presentations. This study is approved by the Children’s Health Queensland Hospital and Health Service Human Research Ethics committee.Trial registration numberACTRN12620001170910p; Australian New Zealand Clinical Trials Registry.
ISSN:2044-6055
2044-6055
DOI:10.1136/bmjopen-2021-057465