Status:
RECRUITING
Open Versus Arthroscopic Stabilization of Shoulder Instability With Subcritical Bone Loss: The OASIS Trial
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
Duke University
Conditions:
Shoulder Dislocation
Glenohumeral Dislocation
Eligibility:
All Genders
17-50 years
Brief Summary
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 rehabi...
Detailed 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-operati...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 24 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT04809064
Start Date
January 24 2022
End Date
September 30 2027
Last Update
October 10 2025
Active Locations (15)
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1
Mayo Clinic
Tempe, Arizona, United States, 85288
2
Naval Medical Center
San Diego, California, United States, 92134
3
Steadman Clinic
Vail, Colorado, United States, 81657
4
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030