Tuesday, January 18, 2022
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, has received FDA (Food and Drug Administration) Investigational Device Exemption (IDE) approval to initiate a pivotal clinical study to further evaluate the company's Reverse Hip Replacement System (Reverse HRS) for use in primary total hip arthroplasty (THA).
The clinical study objective is to evaluate the safety and effectiveness of the Reverse HRS in patients undergoing THA. Safety will be assessed 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.
"The Reverse HRS is a unique hip implant design that represents a significant advancement for patients requiring total hip arthroplasty," said George Diamantoni, Hip Innovation Technology's Co-Founder and Chief Executive Officer. "In our pivotal study we will further evaluate potential Reverse HRS patient benefits including hip stability at extended ranges of motion, reduced risk of device dislocation, and greater latitude for placement of hip components."
In an ongoing 100-patient clinical study, the company has collected outcomes data from multiple sources including radiostereometric analysis (RSA). RSA is a state-of-the-art x-ray technique used to evaluate device micro-motion and wear. Data from the first 21 patients demonstrates minimal migration between 12 and 24 months for both the femoral and acetabular components. Mean migration was below detection and no migration concern was identified among all study patients. Importantly, patient Recorded Outcome Measure (PROM) data suggest significant improvement from pre- to post-operative patient and physician perspectives.
"The Reverse HRS first phase RSA clinical data evaluating implant micro-motion of the acetabular and femoral components has demonstrated each to be at a "not at risk" category for aseptic loosening indicating predictable long-term fixation," said Steve MacDonald, MD, Professor and JC Kennedy Chairman of Orthopaedic Surgery at the University of Western Ontario in London, Ontario, Canada. "The FDA IDE trial that will begin in 2022 will further assess the Reverse HRS clinical performance in multiple sites, in the U.S."
Total hip replacements are one of the most effective ways to reduce joint pain and improve functioning for patients with advanced hip problems. According to the American Academy of Orthopaedic Surgeons (AAOS), over 450,000 hip replacements are performed each year in the U.S..