This research will help Service Members who sustain a shoulder injury and require surgery to fix a rotator cuff (RC) tear. This musculoskeletal condition is a major source of medical hardship for the military and shoulder injuries cost the United States nearly $7 billion annually. In fact, data from FY2010-FY2020 military records revealed that shoulder surgeries accounted for nearly 200,000 cases. Most concerning is that up to 60% of RC tears require a second operation due to failure at the bone and tendon junction. Military personnel have physically demanding jobs, and being unable to serve on active duty for three to six months (potentially multiple times) negatively impacts our country's readiness and resilience.
Sparta Biopharma, Inc., (Sparta) will address this medical hardship through its novel, first-of-its-kind, product called BioEnthesis™. BioEnthesis™ uses a two-sided scaffold with surfaces conducive for hard and soft tissue attachment; this matches what the human body does naturally. BioEnthesis™ has received Food and Drug Administration (FDA) approval, but to date, has not been tested in a randomized control trial (RCT) comparing the clinical safety and efficacy with the standard of care (SoC) consisting of sutures/anchors. Given the unique structure of BioEnthesis™, we hypothesize that patients in this interventional group will experience enhanced mobility, reduced pain, and less retears after RC procedures versus traditional medicine.
Patients who are at least 18 years of age and scheduled for a RC surgery at Walter Reed National Military Medical Center and Brooke Army Medical Center will be invited to participate in this RCT. After consenting, a total of 80 subjects will be assigned to a group (intervention or SoC) through a random number generation. Data from participants will be collected at baseline, surgery, and then at 3-, 6-, and 12-months periods. Participants will also receive magnetic resonance imaging (MRI) at 12 months to assess their healing by their doctors. Additional information collected will include pain scores, the time required to return to sport/work, shoulder function test, etc.
Because the physicians are fixing the RC repair, they cannot be blinded to the treatment type. However, patients will not be told whether they are assigned to the intervention or SoC cohort, along with those who perform follow-up visits/patient score documentation, the MRI imaging, and statisticians who analyze the data. This will limit any bias during evaluation. Information collected herein will be distributed in peer-reviewed publications/conference proceedings and through the Musculoskeletal Injury Rehabilitation Research for Operational Readiness (MIRROR) organization, which has connections to 26 military and academic sites. This approach will ensure that news of this trial reaches important stakeholders in the private and public sectors. Furthermore, Sparta can scale manufacturing of this product in accordance with FDA requirements if data shows improved patient outcomes and becomes the standard for RC repair in the military.
This application also directly addresses the Peer-Reviewed Orthopaedic Research Program Focus Area of 'Retention Strategies: Return to Duty' for Service Members with shoulder injuries. Data collected herein is translational to the civilian community and will have a major medical impact in terms of cost, care, and utilization for our healthcare system.
|Effective start/end date||1/01/21 → …|
- Congressionally Directed Medical Research Programs: $1,555,407.00