Arthroscopic Versus Open Stabilization of Shoulder Instability with Subcortical Bone Loss
Abstract
The objective of this project is to determine the optimal surgical procedure (arthroscopic Bankart with remplissage of Hills-Sachs lesion, open Bankart, Latarjet) and post-operative rehabilitation strategy, with identification of risk-factors for treatment of 400 military personnel and civilians between the ages of 17-50 with acute or recurrent anterior shoulder instability with subcritical bone loss. To date, we have received IRB and HRPO approval for 5sites. There are 6 military and 4 civilian sites working through local IRB approval. Once they have IRB approval, they will be submitted to Pitt IRB Reliance for onboarding. One civilian site is onboarded to the University of Pittsburgh sIRB and is collecting documents to submit to the HRPO for approval. Research activities over the past year have included initiating recruitment at participating sites that are open to recruitment, randomizing participants, beginning follow up procedures, and monitoring. Significant attention has been placed on obtaining all regulatory approvals to activate participating sites for all military sites and recently added civilian locations. Creating and launching a central study website, continued performance of quarterly investigator meetings, monthly steering committee meetings, and monthly coordinator meetings. At this time, we are open for recruitment at 4 sites, with 1 pending within 3-4 weeks. Focus will continue to be on getting sites open to enrollment to achieve our recruitment goals.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2022
- Accession Number
- AD1190851
Entities
People
- Adam J. Popchak
Organizations
- University of Pittsburgh