Positive Clinical Study Data for Novel Reverse Hip Replacement

Hip Innovation Technology (HIT) announced study results with the Reverse Hip Replacement System (Reverse HRS), demonstrating excellent fixation with a predicted low risk of revision at ten years, mean migration below the level of radiostereometric analysis (RSA) detection for both the femoral and acetabular components, and high rates of patient satisfaction. No patients reported symptoms consistent with soft-tissue impingement within the articulation and no symptoms were consistent with adverse reaction to metal debris.

This study enrolled 22 patients and evaluated implant fixation using RSA. RSA markers were viewed via radiologic imaging at six weeks and six, 12 and 24 months.

HIT has extensively tested the Reverse HRS in over 90 standard and unique pre-clinical experiments to assess the product safety and clinical benefits anticipated by the unique system design.

The Reverse HRS is a Metal-on-Polyethylene reverse geometry hip prosthesis designed to improve stability at extended ranges of motion and reduce the risk of dislocation. Like most conventional systems, the Reverse HRS consists of a femoral stem, an acetabular cup and a cobalt-chrome ball that articulates within a polyethylene liner.

Unlike existing total hip replacement systems, the ball is placed on a trunnion within the acetabular cup instead of the femoral stem, and the polyethylene liner is attached to a femoral cup, which then attaches to the femoral stem, as opposed to the polyethylene liner being attached to the acetabular cup. This technological difference does not change the center of rotation of the Reverse HRS, and it remains similar to a normal physiological hip or a well-positioned traditional total hip arthroplasty.

The Reverse HRS implant is designed to provide greater range of motion in all planes, enhanced hip stability and reduce the risk of dislocation. It also provides variability of component placement, including higher abduction angles and anteversion of the acetabular cup.

“We are highly encouraged with the data reported from this Phase 1 clinical study. Importantly, these results also demonstrate very high rates of patient satisfaction based on standard of care patient reported outcome measures,” said George Diamantoni, Hip Innovation Technology’s Co-Founder and Chief Executive Officer. “We remain focused on patient enrollment in our ongoing pivotal study and look forward to providing additional updates regarding our clinical program.”

Source: Hip Innovation Technology, LLC