BMJ Open (Nov 2024)

Multicentre randomised controlled trial comparing Bankart repair with remplissage and Latarjet procedure in shoulder instability with subcritical bone loss (STABLE): study protocol

  • ,
  • Asheesh Bedi,
  • Patrick Henry,
  • Mohit Bhandari,
  • Jaydeep Moro,
  • John Carroll,
  • Sarah Kerslake,
  • Rachel M Frank,
  • Jon Warner,
  • Katrine Milner,
  • Timothy Leroux,
  • Michaela Kopka,
  • Julie-Anne Fritz,
  • Marie-Eve Lebel,
  • Moin Khan,
  • Stéphane Pelet,
  • Kim Madden,
  • Stacey Wanlin,
  • Robert Litchfield,
  • Peter MacDonald,
  • Fatima Nadeem,
  • Paul Dunn,
  • Han Yang,
  • Heather Grant,
  • Nicole Bryant,
  • Ashley Ambrose,
  • Ryan Degen,
  • Miriam Garrido Clua,
  • Danielle Dagher,
  • Asma Mirza,
  • Matthew Denkers,
  • Peter Lapner,
  • Katie McIlquham,
  • Himani Anand,
  • Stephanie Lewaniak,
  • Atqiya Fariha,
  • Alessandra Rodriguez,
  • Priethika Suthakaran,
  • Nithila Sivakumar,
  • Montserrat García Portabella,
  • Josep Massons Albareda,
  • Lledó Batalla Gurrea,
  • Luken Zubizarreta Barrutia,
  • Denisse Guadalupe Loya De la Cerda,
  • Bashar Alolabi,
  • Caralee Bolton,
  • Davide Bardana,
  • Ryan Bicknell,
  • Fiona Howells,
  • Xinning “Tiger” Li,
  • Jayson Saleet,
  • Daniel J Stokes,
  • Rodrigo Ignacio de Marinis Acle,
  • Catalina Victoria Vidal Olate,
  • Abdul-ilah Hachem,
  • Pablo Marcet,
  • Katelyn Inch,
  • Jill Neufeld,
  • Jason Old,
  • Jarret Woodmass,
  • Sheila McRae,
  • Rahne Magnusson,
  • Brenna Cyr,
  • Christine Johnston Heise,
  • Sara Telles-Langdon,
  • Heather Normand,
  • Dan Ogborn,
  • Jeff Leiter,
  • Cristina Ventura-Parellada,
  • Jose M Mora-Guix,
  • Ferran Gamez-Baños,
  • Mar Muñoz Valverde,
  • Carlos Torrens Canovas,
  • Fernando Santana,
  • Tamara Wagner,
  • Lakshmi Ambika,
  • Rania Khalil,
  • Oma Persaud,
  • Amelia Cardoso,
  • Mary Nasim,
  • Ydo V Kleinlugtenbelt,
  • I F Kodde,
  • Ellie B M Landman,
  • Hannie Elskamp-Meijerman,
  • Monique V M Voskamp,
  • Jordi Salvador Carreño,
  • Pablo Castillón Bernal,
  • Pilar Gomez Haccart,
  • Jorge H Nuñez Camarena,
  • Judit López Catena,
  • Laurie A Hiemstra,
  • S Mark Heard,
  • Gregory M Buchko,
  • Katrina Munro,
  • Emilio Calvo Crespo,
  • Cristina Delgado del Caño,
  • Amir Sohail,
  • Sylvie Turmel,
  • Mahdi Alsaffar,
  • Naser Alnusif,
  • Najla Alsiri

DOI
https://doi.org/10.1136/bmjopen-2024-089831
Journal volume & issue
Vol. 14, no. 11

Abstract

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Introduction Recurrent shoulder dislocations often cause 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 for patients with shoulder instability with subcritical bone loss remains unknown and current clinical practice is highly varied.Methods and analysis The Shoulder instability Trial comparing Arthroscopic stabilisation Benefits compared with Latarjet procedure Evaluation (STABLE) is an ongoing multicentre, randomised controlled trial of 114 patients diagnosed with recurrent anterior shoulder instability and subcritical glenoid bone loss (10%–20%, measured on 3D CT using circle of best fit technique). Patients are randomised either arthroscopic capsuloligamentous repair (Bankart repair+remplissage) or open or arthroscopic coracoid transfer (Latarjet procedure). The primary outcome of this trial will be the between-group difference in the change from baseline to 24 months postintervention in Western Ontario Shoulder Instability Index scores. Secondary outcomes include: (1) rates of recurrent shoulder dislocations and symptoms of instability up to 24 months’ postsurgery; (2) clinical outcomes measured by American Shoulder and Elbow Society score, Shoulder Activity Scale, EQ-5D and Patient Satisfaction Scale; (3) physical examination (range of motion, stability); (4) return to previous level of activity/sport; (5) rate of shoulder-related complications and serious adverse events.Ethics and dissemination This protocol has been reviewed and approved by the Hamilton Integrated Research Ethics Board (HiREB; project number 15998) prior to commencement of the trial. Results from the study will be submitted for publication in a peer-reviewed journal regardless of whether there are statistically significant findings.Trial registration number NCT05705479; this study was prospectively registered on clinicaltrials.gov.