A pilot multicenter randomized controlled trial comparing Bankart repair and remplissage with the Latarjet procedure in patients with subcritical bone loss (STABLE): study protocol
Authors: Khan Moin , Bedi Asheesh , Degen Ryan , Warner Jon , Bhandari Mohit ,   on behalf of the STABLE Investigators, Khan Moin , Degen Ryan , Bhandari Mohit , Bedi Asheesh , Warner Jon , Madden Kim , Barkhordari Nazanin , Garrido Clua Miriam , Wozny Kelsey , Moro Jaydeep , Denkers Matthew , Ayeni Olufemi R. , Litchfield Robert , Bryant Diane , Wanlin Stacey , Firth Andrew , Horst Stephanie , Inch Katelyn , Lapner Peter , McIlquham Katie , Garcia Portabella Montserrat , Nuñez Jorge H. , Batalla Lledo , Massons Josep , Henry Patrick , Milner Katrine , Ou Yinmin , Kunz Monica , Alvares Alicia , Moganathas Saranjan , Chandrasegaram Aarani , Oliogu Etinosa , Balasuberamaniam Phumeena , Gundi Barbara , Sivakumar Nithila , Rashid Khadija , Lewaniak Stephanie , Fariha Atqiya , Sri Lavaneyaa , Alolabi Bashar , Bolton Carlee , Li Xinning “Tiger” , Curry Emily , Michlin Dana , Bardana Davide , Bicknell Ryan , Grant Heather , Howells Fiona , MacDonald Peter , Old Jason , Woodmass Jarret , Mcrae Sheila , Bruinooge Brittany , McLennan Derek , Magnusson Rahne , Leroux Timothy , Wagner Tamara , Kopka Michaela , Heard Mark , Buchko Greg , Kerslake Sarah , Frank Rachel M. , McMarty Eric , Barandiaran Andres , Leach Kelly , Suess Kyle , Miller Bruce , Grant John , Ruffino Bethany , Murthi Anand , Jackson Shawanna , de Marinis Acle Rodrigo , Liendo Verdugo Rodrigo , Vidal Olate Catalina , van den Bekerom Michel , van Deurzen Derek , Vorrink Sigrid , Kleinlugtenbelt Ydo V. , Kodde I.F. , Landman Ellie , Elskamp-Meijerman Hannie , Voskamp Monique , Barco Raul , Vaquero Alfonso , Hachem Abdul-ilah , Ventura-Parellada C , Mora Guix JM , Gamez-Baños F 
Published: January 2022

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.