Hip Innovation Technology, LLC (HIT), a medical device company developing innovative orthopedic device solutions to advance the quality of life and quality of care for patients, announces the presentation of data demonstrating the potential utility of its novel Reverse Hip Replacement System (Reverse HRS) in addressing instability following total hip arthroplasty (THA, also referred to as total hip replacement).
In a poster presentation at the annual meeting of the Canadian Orthopaedic Association (COA), researchers reported Phase 1 data showing radiographic stability, as assessed by radio-stereometric analysis (RSA, a state-of-the-art x-ray technique used to evaluate device micro-motion and wear), in patients who underwent THA with the Reverse HRS. The results suggest a low risk of aseptic loosening of the Reverse HRS, and a high likelihood of long-term implant fixation.
“Instability following total hip arthroplasty is a common mode of failure,” commented lead investigator Thomas Turgeon, MD, who is Director of Arthroplasty Research, Concordia Hip and Knee Institute and Board Member of the Orthopaedic Innovation Centre. “The Reverse Hip Replacement System is designed to increase stability at the extremes of motion, and to offer a potentially more forgiving implant positioning without reducing range of motion. The clinical outcome metrics we have observed thus far are consistent with well-functioning hip replacement, and support the stability of this novel implant device.”
Dr. Turgeon and colleagues reported findings from 22 patients (11 female, 11 male; mean age at surgery: 70.6 ± 3.5 years) implanted with the Reverse HRS. The mean 24-month acetabular migration in these patients was 0.09 ± 0.15mm (p=0.005), which compared favorably to the maximum acceptable migration of 0.2mm. Similarly, the mean 24-month femoral migration was 0.002 ± 0.19mm (p<0.001), compared to the maximal acceptable migration of 0.5mm. At 24 months post-THA, the Reverse HRS was also associated with significant improvements in patient-reported outcome measures including the hip disability and osteoarthritis outcome score (HOOS), Oxford Hip Score (OHS), Harris Hip Score (HHS), and the 36-item short-form survey (SF-36) physical score (p<0.001 for all).
“The results from this ongoing RSA assessment trial bolster the clinical rationale for the Reverse HRS and its unique implant design,” said George Diamantoni, Hip Innovation Technology’s Co-Founder and Chief Executive Officer. “The findings further validate and strengthen the importance for our soon to launch FDA approved IDE pivotal trial, which will evaluate the effectiveness and safety of the Reverse HRS in subjects undergoing primary THA. We believe the potential benefits of the Reverse HRS include hip stability at extended ranges of motion, reduced risk of device dislocation, and greater latitude for placement of hip components.”
About the Reverse HRS: 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.