Patients with spinal fusion who have had hip replacements could now have the procedure reversed after the US Food and Drug Administration (FDA) approved the Reverse Hip Replacement System (Reverse HRS) for compassionate use.

The announcement was shared by Hip Innovation Technology, LLC (HIIT), a medical device company focused on developing orthopedic solutions.

“I am extremely encouraged by the opportunity to offer the Reverse Hip Replacement System to an at-risk patient,” said Stephen Zabinski, medical director of joint replacement surgery and assistant chairman of the department of surgery at Shore Medical Center.

“Several patients have been identified as candidates for this compassionate use provision. The patient approved by the FDA is scheduled for the procedure at our institution later this month.”

Data supports compassionate use

Patients with previous spinal fusion face significant challenges with conventional hip replacement systems. Research by Christopher Salib, MD, et al., published in the 2019 Bone & Joint Journal, showed that these patients have an increased risk of dislocation due to changes in spinal pelvic mechanics. Current hip systems do not fully address these altered biomechanics.

Supporting evidence by Arthur Malkani, MD, et al., in the 2018 Journal of Arthroplasty indicated that patients with lumbar fusion have a substantially higher risk of dislocation and failure leading to revision hip surgery compared to those without fusion.

“We are grateful to the FDA for approving compassionate use for our Reverse Hip Replacement System,” said George Diamantoni, CEO of Hip Innovation Technology. “The data from these cases could help expand the existing literature, offering a new option for patients with spinal fusion and spinal pelvic disorders. Our goal is to provide a solution that lowers the risk of dislocation and improves patient outcomes.”

About the Reverse HRS

The Reverse HRS is a Metal-on-Polyethylene reverse geometry hip prosthesis designed to improve stability and reduce the risk of dislocation, especially at extended ranges of motion. The system features a femoral stem, acetabular cup, and a cobalt-chrome ball that articulates within a polyethylene liner. Unlike conventional systems, the ball is placed on a trunnion within the acetabular cup, rather than the femoral stem, with the polyethylene liner attached to the femoral cup.

This design maintains the center of rotation similar to a physiological hip or well-positioned traditional total hip arthroplasty. The Reverse HRS is designed to provide enhanced stability, greater range of motion, and flexibility in component placement. It also reduces the likelihood of dislocation and impingement, compensating for suboptimal component positioning. The advanced implant design aims to eliminate edge loading, thereby reducing high-contact stresses, implant wear, and the generation of wear debris, minimizing concerns related to osteolysis.