Open Versus Arthroscopic Stabilization of Shoulder Instability With Subcritical Bone Loss: The OASIS Trial
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About
This clinical trial will determine the outcome trajectories of common surgeries (arthroscopic Bankart repair with remplissage of a Hill-Sachs lesion, open Bankart, Latarjet) with post-operative rehabilitation and identification of prognostic factors among patients with acute or recurrent anterior shoulder instability with subcritical bone loss. The results of the study assist in optimizing time to return to military duty, work and sports, and patient-reported physical function for military personnel and civilians with traumatic anterior shoulder instability and 10-20% glenoid bone loss. This study will provide a critical clinical advancement of a previously unaddressed and common clinical scenario.
Full description
The objective of this study is to determine the outcome trajectories of common surgeries (arthroscopic Bankart repair with remplissage of a Hill-Sachs lesion, open Bankart, Latarjet) with post-operative rehabilitation and identification of prognostic factors among military personnel and civilians with acute or recurrent anterior shoulder instability with subcritical bone loss.
Aim 1: The investigators will determine the acute and long term patient relevant outcomes (Western Ontario Shoulder Instability score [WOSI], time to RTD/A at pre-injury levels, and recurrent instability/re-injury) at 6 months, 1, and 2 years of arthroscopic Bankart repair with remplissage of a Hill-Sachs lesion, open Bankart, and Latarjet.
Aim 2: The investigators will determine if participation in rehabilitation that optimizes range of motion, strength, and functional performance predicts successful RTD/A, WOSI score, and recurrent instability at 6 months, 1, and 2 years.
Subject Population: Male and female military personnel and civilians between the ages of 17 and 50 with a traumatic anterior shoulder dislocation with associated 10-20% glenoid bone loss, having undergone either an 1) arthroscopic Bankart repair with remplissage of a Hill-Sachs lesion, 2) open Bankart, or a 3) Latarjet, and plans to return to physically demanding work or sports.
Study / Experimental Design: Prospective Observational Cohort Study (Aims 1 & 2).
Methodology: Participants will undergo a standard of care computed tomography (CT) or 3D-MRI scan to quantify glenoid bone loss and shoulders with between 10-20% bone loss will be offered enrollment. We will allow shared decision-making between the patient-participant and the surgeon to occur in order to select the surgical stabilization procedure (arthroscopic Bankart repair with remplissage of a Hill-Sachs lesion, open Bankart, or Latarjet). Only those patients having one of the three surgeries will be eligible for this study. Therefore, male and female military personnel and civilians between the ages of 17 and 50 with a traumatic anterior shoulder dislocation with associated 10-20% glenoid bone loss, plans to return to physically demanding work or sports, and having undergone one of the three surgeries listed above without multi-directional instability, concomitant shoulder pathologies (e.g. rotator cuff tears, motor nerve lesion, fractures, osteoarthritis > Samilson Pietro grade 2), neuromuscular conditions including seizures, a history of shoulder surgery related to any intraarticular soft tissue, and vascular injury will be eligible to participate. We will collect information from the surgeon into what individual factors influenced the decision on surgical selection for each patient-participant.
To address the associated aims, 450 individuals will recruited and enrolled to participate in this study. Participants will be followed for 24 months, with primary outcomes consisting of patient-reported physical function and time to return to pre-injury military duty, work and sports. Secondary outcomes will include shoulder-specific and generic patient-reported measures of physical function and health related quality of life and recurrent instability.
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Inclusion criteria
- Civilians and military personnel ages 17 to 50
- Traumatic anterior shoulder dislocation
- Associated subcritical bone loss between 10-20% less the glenoid width quantified by standard of care CT scan, MRI, or 3D-MRI scan
- Had shoulder instability surgery using either 1) arthroscopic Bankart repair with remplissage of Hill-Sachs lesion; 2) open Bankart; or 3) Latarjet
Exclusion criteria
- Chronic, non-traumatic multi-directional instability based on clinical exam
- Concurrent shoulder injury in the involved shoulder (e.g., rotator cuff tears, motor nerve pathologies, osteoarthritis of a Samilson-Prieto grade >2)
- Have a history of shoulder surgery in the involved shoulder (prior instability surgery that included any of the following and the planned procedure would be a repeat of the index procedure: 1) arthroscopic Bankart repair with a remplissage of Hill-Sachs lesion, 2) open Bankart, or 3) Latarjet [previous isolated arthroscopic Bankart repair only would not be an exclusion criterion], rotator cuff repair, intra-articular soft tissue surgery); rotator cuff repair, intra-articular soft tissue surgery)
- Prior rotator cuff procedure on involved shoulder (including intra-articular soft tissue surgery
- Humeral sided bone lesions (Hill-Sachs lesion) that is sufficiently large enough to render the lesion "off-track" even after a bony augmentation procedure would be performed
- Neuromuscular, neurological and other movement control pathologies including seizures
- Vascular injury associated with the shoulder trauma that compromise adequate/normal healing or interferes with usual course of care
- Traumatic brain injury or any condition that would preclude the ability to comply with post-operative guidelines
- Cartilage lesion finding in the involved shoulder that would interfere with usual course of care
- Known pregnancy at time of imagining and/or surgery based upon standard of care testing procedures
- Any issue with the contralateral shoulder that would preclude participation in research procedures
- Any condition in the opinion of the investigator/clinician that would preclude or limit full participation in study activities
- Absence of a fixed address or no means of contact
- Known inability to be available at all follow-up time points
- Does not plan to return to pre-injury levels of work, sports or military duty
Trial design
450 participants in 3 patient groups
Trial contacts and locations
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Central trial contact
Jonathan Dickens, MD; Adam Popchak, PhD, PT
Data sourced from clinicaltrials.gov
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