NCT04809064 Open Versus Arthroscopic Stabilization of Shoulder Instability With Subcritical Bone Loss: The OASIS Trial
| NCT ID | NCT04809064 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pittsburgh |
| Condition | Shoulder Dislocation |
| Study Type | OBSERVATIONAL |
| Enrollment | 450 participants |
| Start Date | 2022-01-24 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 450 participants in total. It began in 2022-01-24 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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, 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
Contact & Investigator
Adam Popchak, PhD, PT
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT04809064 clinical trial?
This trial is open to participants of all sexes, aged 17 Years or older, up to 50 Years, studying Shoulder Dislocation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04809064 currently recruiting?
Yes, NCT04809064 is actively recruiting participants. Contact the research team at ajp64@pitt.edu for enrollment information.
Where is the NCT04809064 trial being conducted?
This trial is being conducted at Tempe, United States, San Diego, United States, Vail, United States, Farmington, United States and 11 additional locations.
Who is sponsoring the NCT04809064 clinical trial?
NCT04809064 is sponsored by University of Pittsburgh. The principal investigator is Adam Popchak, PhD, PT at University of Pittsburgh. The trial plans to enroll 450 participants.