Uma Srikumaran, Johns Hopkins orthopaedic surgeon, is excited to be able to offer patients new shoulder treatments through his participation in several ongoing FDA clinical trials. He is particularly enthusiastic about helping younger patients avoid joint replacements.
One new treatment under trial is a subacromial balloon spacer for patients with massive rotator cuff tears. The balloon is inserted arthroscopically via a minimally invasive approach. The balloon unrolls, inflates with fluid and fills the gap where the rotator cuff should be but has torn and retracted away.
“It has been found to be very safe in European trials. It is simple, easy to do and will be lower cost than a joint replacement,” Srikumaran says.
The subacromial balloon spacer is also an option for a subset of patients who are not strong candidates for reverse total shoulder replacement or who don’t want to have a joint replacement. Srikumaran says the subacromial balloon spacer fills a gap in terms of available treatments, but he is currently able to offer it only through participation in the clinical trial.
As the value of care becomes increasingly important, Srikumaran says the balloon spacer fits the bill. “A lot of the research we are working on focuses on value-centered treatments,” he says. “These options are faster, cheaper, easier and achieve the same or better outcomes for patients.”
Another new technology Srikumaran and his colleagues are studying is the Conventus CAGE PH for the treatment of complex proximal humerus fractures. The implant is a scaffold structure that is inserted into the bone and expands like a balloon cage, allowing the surgeon to place screws from different angles and support the fractured bone. The cage is intended to overcome some of the limitations of locking plates. Srikumaran expects it will be “a significant step forward in fracture care,” especially for younger patients for whom arthroplasty is not a reasonable option.
Pyrocarbon hemiarthroplasty, a new alternative surface to metal for shoulder arthroplasty devices, may be an answer for young patients with arthritis or avascular necrosis of the humeral head. Srikumaran is part of another trial that is currently evaluating this new material, believed to have advantages for the joint socket in terms of better cartilage protection.
Having worked on an array of complex cases, including revision rotator cuff reconstructions and failed arthroplasties, Srikumaran is collaborating with his fellow clinician-scientists to build the clinical research program. He hopes to offer patients more treatment options before complicated endstage procedures are necessary. “We believe in the careful adoption of new technologies, and participating in multicenter clinical trials allows us to do just that.”