Open Versus Arthroscopic Stabilization of Shoulder Instability with Subcritical Bone Loss: the OASIS Trial

Launched by UNIVERSITY OF PITTSBURGH · Mar 17, 2021

Keywords

ClinConnect Summary

The OASIS Trial is studying different surgical methods to treat shoulder instability, particularly for people who have experienced a traumatic shoulder dislocation and have some bone loss in their shoulder joint. The goal is to find out which surgery helps patients recover the fastest so they can return to their jobs, sports, or military duties, while also improving their shoulder function. This trial is open to military personnel and civilians aged 17 to 50 who have had a recent shoulder dislocation and have a specific amount of bone loss that can be measured through a CT scan.

Participants in the trial will undergo one of three surgical procedures and will follow a post-operative rehabilitation program. To be eligible, individuals must have experienced a recent shoulder dislocation with 10-20% bone loss in the shoulder joint but should not have any other chronic shoulder issues, significant prior injuries, or conditions that might affect their recovery. Those who join the trial can expect close monitoring and support as they work towards regaining full function in their shoulder.

Gender

ALL

Eligibility criteria

• 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
• Exclusion Criteria:
• • Chronic, non-traumatic multi-directional instability based on clinical exam.
• • Concurrent shoulder injury (e.g. rotator cuff tears, motor nerve pathologies, osteoarthritis of a Samilson-Prieto grade \>2).
• • Prior instability or rotator cuff procedure on involved shoulder (including intra-articular soft tissue surgery).
• • Humeral sided bone lesion (Hill-Sachs lesion) that is sufficiently large enough to render the lesion "off-track" even after a bony augmentation procedure would be performed.
• • Neuromuscular and other movement control pathologies including seizures.
• • Vascular injury associated with the shoulder trauma.
• • Traumatic brain injury or any condition that would preclude the ability to comply with post-operative guidelines.
• • Does not plan to return to pre-injury levels of work, sports or military duty.