Single versus double hamstring tendon graft in anterior cruciate ligament reconstruction in the paediatric patient: a single-blind randomised controlled trial study protocol
Robert S Ware,
Christopher P Carty,
Joshua Byrnes,
David Bade,
Liam Johnson,
Chris Stockton,
Garrett Malayko,
Kylie Bradford,
Tristan Reddan,
Kieran Frawley,
Teresa Phillips,
David Saxby
Affiliations
Robert S Ware
Alliance for Vascular Access Teaching and Research Group, Griffith University, Nathan, Queensland, Australia
Christopher P Carty
1 School of Allied Health Sciences, Griffith University, Gold Coast, Queensland, Australia
Joshua Byrnes
Alliance for Vascular Access Teaching and Research Group, Griffith University, Nathan, Queensland, Australia
David Bade
8 Department of Orthopaedics, Queensland Children`s Hospital, South Brisbane, Queensland, Australia
Liam Johnson
1 Stroke Division, The Florey Institute of Neuroscience and Mental Health, University of Melbourne, Heidelberg, Victoria, Australia
Chris Stockton
Medical Imaging and Nuclear Medicine, Queensland Children`s Hospital, South Brisbane, Queensland, Australia
Garrett Malayko
Department of Orthopaedics, Children`s Health Queensland Hospital and Health Service, South Brisbane, Queensland, Australia
Kylie Bradford
Department of Orthopaedics, Children`s Health Queensland Hospital and Health Service, South Brisbane, Queensland, Australia
Tristan Reddan
Department of Medical Imaging and Nuclear Medicine, Children`s Health Queensland Hospital and Health Service, South Brisbane, Queensland, Australia
Kieran Frawley
Department of Medical Imaging and Nuclear Medicine, Children`s Health Queensland Hospital and Health Service, South Brisbane, Queensland, Australia
Teresa Phillips
Department of Orthopaedics, Children`s Health Queensland Hospital and Health Service, South Brisbane, Queensland, Australia
David Saxby
Griffith Centre of Biomedical and Rehabilitation Engineering, Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia
Introduction There 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 analysis Single 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 dissemination Results 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 number ACTRN12620001170910p; Australian New Zealand Clinical Trials Registry.
