Shoulder Dislocation Clinical Trial
Official title:
Open Versus Arthroscopic Stabilization of Shoulder Instability With Subcritical Bone Loss: The OASIS Trial
This clinical trial will investigate the effects of three surgical procedures and the associated post-operative rehabilitation to optimize 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.
The objective of this clinical trial is to determine the optimal surgical procedure and post-operative rehabilitation strategy for treatment of military personnel and civilians with shoulder instability and subcritical bone loss. Investigators will conduct a randomized, controlled trial comparing arthroscropic Bankart with remplissage/rehabilitation versus open Bankart/rehabilitation versus Latarjet/rehabilitation. Aim 1: The investigators will determine the effects of arthroscopic Bankart repair with remplissage of a Hill-Sachs lesion versus open Bankart versus Latarjet on patient reported outcomes (Western Ontario Shoulder Instability score [WOSI]), time to Return to Duty/Activity (RTD/A) at pre-injury levels, and recurrent instability/re-injury at 6 months, 1 and 2 years. 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 and plans to return to physically demanding work or sports, 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. Study / Experimental Design: Randomized controlled trial (Aim 1), Prospective cohort (Aim 2). Methodology: 400 individuals will be randomized to arthroscopic Bankart with remplissage of a Hill-Sachs lesion/rehabilitation vs. open Bankart/rehabilitation vs. open Latarjet/rehabilitation. To address Aim 1, individuals with traumatic anterior shoulder instability with subcritical bone loss will be randomized to arthroscopic Bankart repair with remplissageof a Hill-Sachs lesion, or open Bankart, or Latarjet. To address Aim 2, all individuals will enter into rehabilitation with specific instructions for the first 12 weeks dependent on the surgical arm to which they are randomized. After week 12, all rehabilitation programs will be similar and progressed based upon the results of interim testing at 3, 4, and 6 months. 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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