The objective of the clinical trial is to evaluate the effectiveness and safety of the HRS hip replacement system in 100–120 patients receiving a total hip arthroplasty (THA). Effectiveness will be evaluated using clinical, radiologic, radiostereometric and patient-reported outcomes. Safety will be assessed through the collection of device-related adverse events. Patient quality of life metrics will also be closely monitored.
"The HRS is a unique hip implant design that we believe represents breakthrough technology and a significant advancement for patients requiring total hip arthroplasty," said George Diamantoni, Hip Innovation Technology's co-founder and CEO. "We look forward to confirming potential differentiating 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 current designs."
The company has extensively tested the HRS in over 80 standard and unique pre-clinical experiments to assess the product safety and clinical benefits anticipated by the unique system design.
"The bench level data compiled for the HRS is more extensive than any that I have reviewed for currently marketed hip implant systems," said Thomas Turgeon, M.D., chief medical officer of the Orthopaedic Innovation Centre, and Orthopaedic Surgeon at Concordia Joint Replacement Group. "I am impressed with the unique system design. I look forward to assessing its clinical performance, and am hopeful that many patients will benefit from this novel device."
Total hip replacements are one of the most effective ways to reduce joint pain and improve functioning for patients with advanced hip problems. During the 2015 calendar year, approximately 324,000 surgeries were performed in the U.S. and 50,000 in Canada.