Single versus double hamstring tendon graft in anterior cruciate ligament reconstruction in the paediatric patient: a single-blind randomised controlled trial study protocol
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 determin...
| Main Authors: | , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2022-08-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/8/e057465.full |
| _version_ | 1798037529643974656 |
|---|---|
| author | 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 |
| author_facet | 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 |
| author_sort | Robert S Ware |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-11T21:27:47Z |
| format | Article |
| id | doaj.art-95c6be671b1f48e3936fcee2403baa69 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-04-11T21:27:47Z |
| publishDate | 2022-08-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-95c6be671b1f48e3936fcee2403baa692022-12-22T04:02:20ZengBMJ Publishing GroupBMJ Open2044-60552022-08-0112810.1136/bmjopen-2021-057465Single versus double hamstring tendon graft in anterior cruciate ligament reconstruction in the paediatric patient: a single-blind randomised controlled trial study protocolRobert S Ware0Christopher P Carty1Joshua Byrnes2David Bade3Liam Johnson4Chris Stockton5Garrett Malayko6Kylie Bradford7Tristan Reddan8Kieran Frawley9Teresa Phillips10David Saxby11Alliance for Vascular Access Teaching and Research Group, Griffith University, Nathan, Queensland, Australia1 School of Allied Health Sciences, Griffith University, Gold Coast, Queensland, AustraliaAlliance for Vascular Access Teaching and Research Group, Griffith University, Nathan, Queensland, Australia8 Department of Orthopaedics, Queensland Children`s Hospital, South Brisbane, Queensland, Australia1 Stroke Division, The Florey Institute of Neuroscience and Mental Health, University of Melbourne, Heidelberg, Victoria, AustraliaMedical Imaging and Nuclear Medicine, Queensland Children`s Hospital, South Brisbane, Queensland, AustraliaDepartment of Orthopaedics, Children`s Health Queensland Hospital and Health Service, South Brisbane, Queensland, AustraliaDepartment of Orthopaedics, Children`s Health Queensland Hospital and Health Service, South Brisbane, Queensland, AustraliaDepartment of Medical Imaging and Nuclear Medicine, Children`s Health Queensland Hospital and Health Service, South Brisbane, Queensland, AustraliaDepartment of Medical Imaging and Nuclear Medicine, Children`s Health Queensland Hospital and Health Service, South Brisbane, Queensland, AustraliaDepartment of Orthopaedics, Children`s Health Queensland Hospital and Health Service, South Brisbane, Queensland, AustraliaGriffith Centre of Biomedical and Rehabilitation Engineering, Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, AustraliaIntroduction 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.https://bmjopen.bmj.com/content/12/8/e057465.full |
| spellingShingle | 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 Single versus double hamstring tendon graft in anterior cruciate ligament reconstruction in the paediatric patient: a single-blind randomised controlled trial study protocol BMJ Open |
| title | Single versus double hamstring tendon graft in anterior cruciate ligament reconstruction in the paediatric patient: a single-blind randomised controlled trial study protocol |
| title_full | Single versus double hamstring tendon graft in anterior cruciate ligament reconstruction in the paediatric patient: a single-blind randomised controlled trial study protocol |
| title_fullStr | Single versus double hamstring tendon graft in anterior cruciate ligament reconstruction in the paediatric patient: a single-blind randomised controlled trial study protocol |
| title_full_unstemmed | Single versus double hamstring tendon graft in anterior cruciate ligament reconstruction in the paediatric patient: a single-blind randomised controlled trial study protocol |
| title_short | Single versus double hamstring tendon graft in anterior cruciate ligament reconstruction in the paediatric patient: a single-blind randomised controlled trial study protocol |
| title_sort | single versus double hamstring tendon graft in anterior cruciate ligament reconstruction in the paediatric patient a single blind randomised controlled trial study protocol |
| url | https://bmjopen.bmj.com/content/12/8/e057465.full |
| work_keys_str_mv | AT robertsware singleversusdoublehamstringtendongraftinanteriorcruciateligamentreconstructioninthepaediatricpatientasingleblindrandomisedcontrolledtrialstudyprotocol AT christopherpcarty singleversusdoublehamstringtendongraftinanteriorcruciateligamentreconstructioninthepaediatricpatientasingleblindrandomisedcontrolledtrialstudyprotocol AT joshuabyrnes singleversusdoublehamstringtendongraftinanteriorcruciateligamentreconstructioninthepaediatricpatientasingleblindrandomisedcontrolledtrialstudyprotocol AT davidbade singleversusdoublehamstringtendongraftinanteriorcruciateligamentreconstructioninthepaediatricpatientasingleblindrandomisedcontrolledtrialstudyprotocol AT liamjohnson singleversusdoublehamstringtendongraftinanteriorcruciateligamentreconstructioninthepaediatricpatientasingleblindrandomisedcontrolledtrialstudyprotocol AT chrisstockton singleversusdoublehamstringtendongraftinanteriorcruciateligamentreconstructioninthepaediatricpatientasingleblindrandomisedcontrolledtrialstudyprotocol AT garrettmalayko singleversusdoublehamstringtendongraftinanteriorcruciateligamentreconstructioninthepaediatricpatientasingleblindrandomisedcontrolledtrialstudyprotocol AT kyliebradford singleversusdoublehamstringtendongraftinanteriorcruciateligamentreconstructioninthepaediatricpatientasingleblindrandomisedcontrolledtrialstudyprotocol AT tristanreddan singleversusdoublehamstringtendongraftinanteriorcruciateligamentreconstructioninthepaediatricpatientasingleblindrandomisedcontrolledtrialstudyprotocol AT kieranfrawley singleversusdoublehamstringtendongraftinanteriorcruciateligamentreconstructioninthepaediatricpatientasingleblindrandomisedcontrolledtrialstudyprotocol AT teresaphillips singleversusdoublehamstringtendongraftinanteriorcruciateligamentreconstructioninthepaediatricpatientasingleblindrandomisedcontrolledtrialstudyprotocol AT davidsaxby singleversusdoublehamstringtendongraftinanteriorcruciateligamentreconstructioninthepaediatricpatientasingleblindrandomisedcontrolledtrialstudyprotocol |