Hip Innovation Technology Initiates FDA Approved Investigational Device Exemption Study

Hip Innovation Technology LLC (HIT), a medical device company developing orthopedic device solutions to advance the quality of life and quality of care for patients, has announced the first U.S. implantation of the HIT Reverse Hip Replacement System (Reverse HRS), under an FDA approved Investigational Device Exemption (IDE).
 
The IDE Study is being conducted to determine the safety and effectiveness of the HIT Reverse HRS in Primary Total Hip Arthroplasty (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.
 
Stephen Zabinski, MD, Director of the Division of Orthopedic Surgery, Shore Medical Center in Ocean City, New Jersey, performed the first surgery using this new technology on January 10, 2023. Zabinski states, “The reverse hip replacement system offers potential unique benefits regarding motion and stability. My first patient was very educated and after researching the implant, was motivated to proceed. Her surgery went extremely well and I’m excited to see her in follow up, and to use the Reverse HRS in additional patients.”
 
“The Reverse HRS is a novel hip implant design that we believe represents breakthrough technology and a significant advancement for patients requiring total hip arthroplasty,” said George Diamantoni, co-founder and chief executive officer of Hip Innovation Technology. “We look forward to rapidly enrolling patients in this important clinical study and validating potential clinical benefits including, hip stability at extended ranges of motion, reduced risk of device dislocation and greater latitude for placement of hip components relative to the currently marketed designs.”
 
With HIT’s ongoing Canadian Clinical Study in Winnipeg, over five years of patient data has been collected using Radio-Stereometric Analysis (RSA) that demonstrates excellent fixation and aggregate data to suggest significant improvement from pre- to post-operative patient and physician measures. The Reverse HRS has also been extensively tested in over 100 standard and unique pre-clinical, bench level experiments assessing the product safety and clinical benefits anticipated by the reverse system design. 
 
“The bench level data compiled for the Reverse HRS exceeded all FDA requirements, setting the stage for clinical use,” said Steve MacDonald, MD, Professor and JC Kennedy Chairman of Orthopaedic Surgery at the University of Western Ontario in London, Ontario, Canada. “The clinical trial that has been performed in Canada has demonstrated excellent prosthesis to bone interface stability as evidenced by RSA data.   The novel Reverse HRS is now beginning enrollment in the FDA IDE clinical trial with multiple outcome measures being evaluated.” 
 
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 United States.