BOCA RATON, Fla., July 20, 2022 /PRNewswire/ — 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.
About Hip Innovation Technology, LLC
Hip Innovation Technology, founded in 2011, provides market-leading orthopedic device solutions that advances quality of life and quality of care for patients. In partnership with healthcare professionals worldwide, our goal is to design, manufacture and ultimately market innovative orthopaedic reconstructive and related surgical product solutions in areas of high unmet medical need.
For more information, visit www.hipinnovationtechnology.com.
Cautionary Statement Regarding Forward-Looking Statements
This news release may contain forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning Hip Innovation Technology’s expectations, plans, prospects, and product and service offerings, including new product launches and potential clinical successes. Such statements are based upon the current beliefs and expectations of management and are subject to significant risks and uncertainties that could cause actual outcomes and results to differ materially. Hip Innovation Technology disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Accordingly, such forward-looking statements speak only as of the date made. Readers of this news release are cautioned not to place undue reliance on these forward-looking statements, since, while management believes the assumptions on which the forward-looking statements are based are reasonable, there can be no assurance that these forward-looking statements will prove to be accurate. This cautionary statement is applicable to all forward-looking statements contained in this news release.
George Diamantoni, CEO
Hip Innovation Technology
John F. Kouten
JFK Communications, Inc.
SOURCE Hip Innovation Technology