The Stability study: a protocol for a multicenter randomized clinical trial comparing anterior cruciate ligament reconstruction with and without Lateral Extra-articular Tenodesis in individuals who are at high risk of graft failure

Alan Getgood, Dianne Bryant, Andrew Firth, Stability Group, Alan Getgood, Robert Litchfield, Kevin Willits, Chris Hewison, Nicole Kaniki, Alliya Remtulla, Stacey Wanlin, Andrew Firth, Ryan Pinto, Ashley Martindale, Lindsey O'Neill, Morgan Jennings, Michal Daniluk, Dianne Bryant, Trevor Birmingham, Dory Boyer, Bob McCormack, Mauri Zomar, Karyn Moon, Raely Moon, Brenda Fan, Bindu Mohan, Mark Heard, Greg Buchko, Laurie Hiemstra, Sarah Kerslake, Meagan Heard, Peter MacDonald, Greg Stranges, Sheila Mcrae, Lee Anne Gullett, Holly Brown, Alexandra Legary, Alison Longo, Mat Christian, Celeste Ferguson, Alex Rezansoff, Nick Mohtadi, Rhamona Barber, Denise Chan, Caitlin Campbell, Alexandra Garven, Karen Pulsifer, Michelle Mayer, Devin Peterson, Nicole Simunovic, Andrew Duong, Zakia Islam, Davide Bardana, Fiona Howells, Murray Tough, Tim Spalding, Pete Thompson, Andrew Metcalfe, Juul Achten, Michael Thomas, Andrew Legg, Lior Laver, Laura Asplin, Alisen Dube, Louise Clarkson, Jaclyn Brown, Alison Bolsover, Carolyn Bradshaw, Larissa Belgrove, Francis Millan, Sylvia Turner, Sarah Verdugo, Janet Lowe, Debra Dunne, Kerri McGowan, Charlie-Marie Suddens, Peter Verdonk, Geert Declerq, Kristien Vuylsteke, Mieke Van Haver, Alan Getgood, Dianne Bryant, Andrew Firth, Stability Group, Alan Getgood, Robert Litchfield, Kevin Willits, Chris Hewison, Nicole Kaniki, Alliya Remtulla, Stacey Wanlin, Andrew Firth, Ryan Pinto, Ashley Martindale, Lindsey O'Neill, Morgan Jennings, Michal Daniluk, Dianne Bryant, Trevor Birmingham, Dory Boyer, Bob McCormack, Mauri Zomar, Karyn Moon, Raely Moon, Brenda Fan, Bindu Mohan, Mark Heard, Greg Buchko, Laurie Hiemstra, Sarah Kerslake, Meagan Heard, Peter MacDonald, Greg Stranges, Sheila Mcrae, Lee Anne Gullett, Holly Brown, Alexandra Legary, Alison Longo, Mat Christian, Celeste Ferguson, Alex Rezansoff, Nick Mohtadi, Rhamona Barber, Denise Chan, Caitlin Campbell, Alexandra Garven, Karen Pulsifer, Michelle Mayer, Devin Peterson, Nicole Simunovic, Andrew Duong, Zakia Islam, Davide Bardana, Fiona Howells, Murray Tough, Tim Spalding, Pete Thompson, Andrew Metcalfe, Juul Achten, Michael Thomas, Andrew Legg, Lior Laver, Laura Asplin, Alisen Dube, Louise Clarkson, Jaclyn Brown, Alison Bolsover, Carolyn Bradshaw, Larissa Belgrove, Francis Millan, Sylvia Turner, Sarah Verdugo, Janet Lowe, Debra Dunne, Kerri McGowan, Charlie-Marie Suddens, Peter Verdonk, Geert Declerq, Kristien Vuylsteke, Mieke Van Haver

Abstract

Background: The purpose of anterior cruciate ligament reconstruction (ACLR) is to restore stability to the knee. Persistent rotational laxity following ACLR has been correlated with poor outcome and graft failure. We hypothesize that anterolateral complex reconstruction by way of a Modified Lemaire Lateral Extra-articular Tenodesis (LET) in combination with single bundle ACLR would reduce the risk of persistent rotatory laxity in young individuals who are deemed as being at high risk of failure. We will conduct a pragmatic, multicenter, randomized clinical trial comparing standard single bundle hamstring ACLR with combined ACLR and LET.

Methods: Six-hundred patients (300 per group) aged 25 years or less with an ACL deficient knee that meet two of the following three criteria will be included: 1) Grade 2 pivot shift or greater; 2) Returning to high risk cutting or pivoting sports; 3) Generalized ligamentous laxity. Participants will be seen at 3-months, 6-months, 12-months and 24-months post-operatively. The primary outcome measure is graft failure requiring revision ACLR or symptomatic instability associated with a positive asymmetric pivot shift indicating persistent rotational laxity. Patients will complete secondary outcome measures at each follow-up visit including patient-reported outcome measures, functional and biomechanical testing, and magnetic resonance imaging.

Discussion: This protocol is the first adequately powered randomized clinical trial investigating the effects of augmenting ACLR with an LET in patients at high-risk of graft failure. The successful completion of this trial has the potential to change surgical practice and provide evidence for the role of the LET in ACLR.

Trial registration: The trial is registered at ClinicalTrials.gov: NCT02018354 , 23-12-2013.

Keywords: Anterior cruciate ligament (ACL) repair; Anterolateral ligament; Orthopaedics; Tenodesis.

Conflict of interest statement

Ethics approval and consent to participate

The Stability study, A Multicenter Randomized Clinical Trial comparing Anterior Cruciate Ligament Reconstruction With and Without Lateral Extra-articular Tenodesis in Individuals Who Are At High Risk of Graft Failure (REF #: 104524), was approved by the University of Western Ontario Health Science Research Ethics Board (HSREB) on February 7, 2014 after undergoing full board review. Ethics approval was obtained by the following ethics boards at each participating site in Canada, the United Kingdom and Belgium:

University of Calgary Conjoint Health Research Ethics Board (REB14–0067), Fraser Health Research Ethics Board (FHREB2014–010), Hamilton Integrated Research Ethics Board (14–446), University of Manitoba Biomedical Research Ethics Board (HS18187 (B2014:016)), Queen’s University Health Sciences & Affiliated Teaching Hospitals Research Ethics Board (#6012928), University of Calgary Conjoint Health Research Ethics (REB15–1706), West-Midlands: Coventry & Warwickshire Research Ethics Committee (15/WM/0398), Ethisch Comité UZ Antwerpen (14/18/210, Belgian registration number: b300201421344).

Written informed consent will be obtained from each participant before enrolling them in the study. Patients under the age of 18 years will be provided with information about the study and will be asked to provide their written consent along with legal guardian written consent. Participation is voluntary and patients are free to refuse participation or withdraw from the study at any time with no effect on their future care. Patients do not waive any legal right by signing the consent form.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Study Flow Diagram

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