ConforMIS, Inc., a medical device company pioneering patient-specific orthopaedic implants, today announced results from several clinical research studies highlighting the benefits of the iTotal® patient-specific total knee replacement. Results were shown at the British Association for Surgery of the Knee (BASK) meeting in Norwich, UK.
The iTotal system, the only patient-specific total knee replacement system on the market, demonstrated zero blood transfusions and positive clinical outcomes. A recent Cleveland Clinic study reported a 12% rate of blood transfusions for traditional, off-the-shelf knee replacements. These transfusions were associated with increased costs of over $2,200 per incident, longer hospital stays and a higher incidence of complications. In a review of 106 iTotal replacements, including 15 simultaneous bilateral replacements, there were no blood transfusions required.
Even more important, 100% of patients reported a normal feeling knee only seven months after the procedure. This is in contrast to high dissatisfaction rates reported in the literature, ranging from 15% to 39% of knee replacement patients with standard, off-the-shelf implants.
"We are very pleased to see further clinical evidence showing that the ConforMIS patient-specific technology is not only helping surgeons to improve patient outcomes with knee replacements, but the technology is also contributing meaningful cost savings to the healthcare system," said Philipp Lang, M.D., Chairman and CEO of ConforMIS. "We believe that by providing a patient-specific implant, patients will recover faster, quickly return to normal, everyday activities and ultimately forget they even had a knee replacement."
ConforMIS clinical results presented at BASK include:
- "Early Outcomes Utilizing a First-Generation Customized Patient-Specific TKA Implant" (P0185). Lead researcher William Kurtz, M.D. shared the clinical results of patients implanted with the first-generation patient-specific iTotal implant. In a population of 89 patients and 106 knees treated, no patients required blood transfusions and mean pre-op range of motion (ROM) was regained within an average of four months. No patients reported any dissatisfaction in four of five Knee Scoring System (KSS) categories, including pain while sitting and function while performing recreational activities. Unprecedented to any published reports on standard, off-the-shelf implants, all patients receiving iTotal reported a "normal" feeling knee seven months after the procedure.
- "Intraoperative Assessment of Mechanical Alignment Accuracy Determined by Computer Navigation in a Patient-Specific TKA (Total Knee Arthroplasty) System" (Session 6). Data presented by Gary A. Levengood, M.D. demonstrated that in a population of 63 patients treated with iTotal, 100% achieved alignment within ± 2° of the neutral mechanical axis. Restoration of alignment within 3° of neutral is a widely confirmed indicator of improved long-term survivorship in TKA.
- "In Vivo Tibial Fit Analysis of Customized, Patient-Specific TKA Versus Off-the-Shelf TKA" (P0181). Data demonstrated that use of iTotal significantly improves tibial fit when compared to off-the-shelf TKA implants. The study concluded, "this could play an important role in reducing knee pain and patient dissatisfaction … as well as implant loosening."