A pilot multicenter randomized controlled trial comparing Bankart repair and remplissage with the Latarjet procedure in patients with subcritical bone loss (STABLE): study protocol

Moin Khan, Asheesh Bedi, Ryan Degen, Jon Warner, Mohit Bhandari, STABLE Investigators, Moin Khan, Ryan Degen, Mohit Bhandari, Asheesh Bedi, Jon Warner, Kim Madden, Nazanin Barkhordari, Miriam Garrido Clua, Kelsey Wozny, Jaydeep Moro, Matthew Denkers, Olufemi R Ayeni, Robert Litchfield, Diane Bryant, Stacey Wanlin, Andrew Firth, Stephanie Horst, Katelyn Inch, Peter Lapner, Katie McIlquham, Montserrat Garcia Portabella, Jorge H Nuñez, Lledo Batalla, Josep Massons, Patrick Henry, Katrine Milner, Yinmin Ou, Monica Kunz, Alicia Alvares, Saranjan Moganathas, Aarani Chandrasegaram, Etinosa Oliogu, Phumeena Balasuberamaniam, Barbara Gundi, Nithila Sivakumar, Khadija Rashid, Stephanie Lewaniak, Atqiya Fariha, Lavaneyaa Sri, Bashar Alolabi, Carlee Bolton, Xinning Tiger Li, Emily Curry, Dana Michlin, Davide Bardana, Ryan Bicknell, Heather Grant, Fiona Howells, Peter MacDonald, Jason Old, Jarret Woodmass, Sheila Mcrae, Brittany Bruinooge, Derek McLennan, Rahne Magnusson, Timothy Leroux, Tamara Wagner, Michaela Kopka, Mark Heard, Greg Buchko, Sarah Kerslake, Rachel M Frank, Eric McMarty, Andres Barandiaran, Kelly Leach, Kyle Suess, Bruce Miller, John Grant, Bethany Ruffino, Anand Murthi, Shawanna Jackson, Rodrigo de Marinis Acle, Rodrigo Liendo Verdugo, Catalina Vidal Olate, Michel van den Bekerom, Derek van Deurzen, Sigrid Vorrink, Ydo V Kleinlugtenbelt, I F Kodde, Ellie Landman, Hannie Elskamp-Meijerman, Monique Voskamp, Raul Barco, Alfonso Vaquero, Abdul-Ilah Hachem, C Ventura-Parellada, J M Mora Guix, F Gamez-Baños, Moin Khan, Asheesh Bedi, Ryan Degen, Jon Warner, Mohit Bhandari, STABLE Investigators, Moin Khan, Ryan Degen, Mohit Bhandari, Asheesh Bedi, Jon Warner, Kim Madden, Nazanin Barkhordari, Miriam Garrido Clua, Kelsey Wozny, Jaydeep Moro, Matthew Denkers, Olufemi R Ayeni, Robert Litchfield, Diane Bryant, Stacey Wanlin, Andrew Firth, Stephanie Horst, Katelyn Inch, Peter Lapner, Katie McIlquham, Montserrat Garcia Portabella, Jorge H Nuñez, Lledo Batalla, Josep Massons, Patrick Henry, Katrine Milner, Yinmin Ou, Monica Kunz, Alicia Alvares, Saranjan Moganathas, Aarani Chandrasegaram, Etinosa Oliogu, Phumeena Balasuberamaniam, Barbara Gundi, Nithila Sivakumar, Khadija Rashid, Stephanie Lewaniak, Atqiya Fariha, Lavaneyaa Sri, Bashar Alolabi, Carlee Bolton, Xinning Tiger Li, Emily Curry, Dana Michlin, Davide Bardana, Ryan Bicknell, Heather Grant, Fiona Howells, Peter MacDonald, Jason Old, Jarret Woodmass, Sheila Mcrae, Brittany Bruinooge, Derek McLennan, Rahne Magnusson, Timothy Leroux, Tamara Wagner, Michaela Kopka, Mark Heard, Greg Buchko, Sarah Kerslake, Rachel M Frank, Eric McMarty, Andres Barandiaran, Kelly Leach, Kyle Suess, Bruce Miller, John Grant, Bethany Ruffino, Anand Murthi, Shawanna Jackson, Rodrigo de Marinis Acle, Rodrigo Liendo Verdugo, Catalina Vidal Olate, Michel van den Bekerom, Derek van Deurzen, Sigrid Vorrink, Ydo V Kleinlugtenbelt, I F Kodde, Ellie Landman, Hannie Elskamp-Meijerman, Monique Voskamp, Raul Barco, Alfonso Vaquero, Abdul-Ilah Hachem, C Ventura-Parellada, J M Mora Guix, F Gamez-Baños

Abstract

Introduction: Anterior dislocations, the most common type of shoulder dislocation, are often complicated by subsequent instability. With recurrent dislocations there often is attrition of the labrum and progressive loss of the anterior bony contour of the glenoid. Treatment options for this pathology involve either soft tissue repair or bony augmentation procedure. The optimal management remains unknown and current clinical practice is highly varied.

Methods and analysis: The Shoulder instability Trial comparing Arthroscopic stabilization Benefits compared with Latarjet procedure Evaluation (STABLE) is an ongoing multi-centre, pilot randomized controlled trial of 82 patients who have been diagnosed with recurrent anterior shoulder instability and subcritical glenoid bone loss. Patients are randomized to either soft tissue repair (Bankart + Remplissage) or bony augmentation (Latarjet procedure). The primary outcome for this pilot is to assess trial feasibility and secondary outcomes include recurrent instability as well as functional outcomes up to two years post-operatively.

Conclusions: This trial will help to identify the optimal treatment for patients with recurrent shoulder instability with a focus on determining which treatment option results in reduced risk of recurrent dislocation and improved patient outcomes. Findings from this trial will guide clinical practice and improve care for patients with shoulder instability.

Trial registration: This study has been registered on http://www.ClinicalTrials.gov with the following identifier: ClinicalTrials.gov Identifier: NCT03585491, registered 13 July 2018, https://www.clinicaltrials.gov/ct2/show/NCT03585491?term=NCT03585491&draw=2&rank=1 .

Ethics and dissemination: This study has ethics approval from the McMaster University/Hamilton Health Sciences Research Ethics Board (REB) (approval #4942). Successful completion will significantly impact the global management of patients with recurrent instability. This trial will develop a network of collaboration for future high-quality trials in shoulder instability.

Keywords: Instability; Randomized; Shoulder; Surgery; Trial.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Figure 1
Figure 1
Trial design overview

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