The 10-year follow-up study of 200 patients aims to evaluate survivorship and to characterize improvements in patient-reported outcomes, Memphis-based Wright said.
At its June 2014 debut, the company touted Infinity as a solution for both primary ankle arthroplasties and secondary or revision surgeries. The device is designed to be compatible with Wright’s Inbone II talar components and the Prophecy pre-operative alignment system.
“With the growing popularity and increasing demand for alternatives to ankle fusion, there is a real need for quality, forward-looking studies that document the results of total ankle replacement surgery to further validate our clinical decision making,” primary investigator Dr. Andrew Murphy, of the Campbell Clinic in Memphis, said in prepared remarks. “Wright Medical is leading the way in this progress, and we expect to glean valuable data from this study of the Infinity total ankle system.”
Wright also said the 500-patient post-market study in the U.K. it launched last year, also designed to evaluate 10-year survivorship and patient-reported outcomes, enrolled 100 patients as of the third quarter.
“It is increasingly important for industry and clinicians to work together to provide patients, colleagues and healthcare providers with robust clinical evidence to support new systems,” added chief investigator Dr. David Townshend of the Northumbria NHS Healthcare Trust. “We are delighted that Wright has taken the opportunity to sponsor a high-quality, multi-center follow-up study in the United Kingdom to evaluate the Infinity total ankle replacement, and we look forward to sharing these results.”
“The undertaking of both the US and UK post-market clinical studies are a testament to Wright’s ongoing commitment to foot and ankle surgeons and their patients,” global clinical affairs VP Ann Burgess said. “By collecting longitudinal patient outcomes through real-world experience of non-design surgeons at centers of excellence around the globe, Wright will generate important information that will drive the continued evolution of the treatment and technologies addressing end-stage ankle arthritis for years to come.”