Podium Presentation Provides Update on the Canadian Experience with the Reverse Hip Replacement System; Proclaims Reverse Hip System is here to Stay
BOCA RATON, Fla., Nov. 19, 2024 /PRNewswire/ -- Thomas Turgeon, MD, Associate Professor, Max Rady College of Medicine, recently presented updated Canadian data using the Reverse Hip Replacement System (Reverse HRS) during a plenary session at the 2024 Orthopedic Summit. Hip Innovation Technology, LLC (HIT), a medical device company, delivering innovative orthopedic device solutions to advance the quality of life and quality of care for patients, is developing the Reverse HRS.
Dr. Turgeon presented the most up to date data from the Canadian trial using the Reverse HRS. The results included 65 patients. The presentation reported on patients who have reached the five-year mark, patients that have surpassed 2 years, and patients that were six-months post-op. The presentation included data on patients who had augmented screw fixation of the acetabular cup and a group that did not have screw fixation. A cohort of these patients surpassed 2 years, and a portion surpassed 1 year and six months.
"To date the radio-stereometric analysis (RSA, placement of tantalum beads prior to implant placement in combination with a special x-ray machine used to evaluate device movement/shifts in the bone and linear wear of polyethylene), of patients with and without screw fixation confirms they are all staying well within the published safe zones for femoral and acetabular migration," said Dr. Turgeon. "These data confirm that the Reverse HRS implant appears to have an excellent fixation to bone, even out as far as five years."
"Another main take-away from this presentation is that the Reverse HRS is behaving very much like a standard hip replacement device. Also, it seems to be more forgiving from a positioning perspective based on its inherent mechanical stability. Consequently, it could very easily play a strong role for patients with spinal-pelvic issues," explains Dr. Turgeon. "Also, with developmental dysplasia that can have unusual geometry in terms of version and inclination, the Reverse HRS may be left in the more native position and still have the stability of the device compared to traditional bearings."
"These Canadian data, especially the RSA assessment data validate 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. "These findings strengthen the importance of our ongoing IDE pivotal trial. 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."
U.S. Development of Reverse HRS Progressing
In addition to extensive clinical research in Canada with the HIT Reverse HRS, a multi-centered FDA-approved Investigational Device Exemption (IDE) study is being conducted to determine the safety and effectiveness of the HIT Reverse HRS in Primary Total Hip Arthroplasty (THA). This registrational study will assess safety through the collection of device-related adverse events and patient quality of life metrics. Effectiveness will be evaluated using clinical, radiologic, and patient-reported outcomes.
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 advance 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 orthopedic reconstructive and related surgical product solutions in areas of high unmet medical need.
Contact:
George Diamantoni, CEO
Hip Innovation Technology
InvestorRelations@HIT-IRH.com
Media:
John F. Kouten
JFK Communications, Inc.
(609) 241-7352
jfkouten@jfkhealth.com
For more information, visit www.hipinnovationtechnology.com.
SOURCE Hip Innovation Technology