ConforMIS Touts Studies’ Results for its iTotal Customized Knee

ConforMIS Inc. recently announced results from several clinical research studies touting the benefits of the the company’s iTotal customized total knee replacement.

According to the company, the iTotal system is the only customized total knee replacement system on the market.

A recent Cleveland Clinic study cited by the company reported a 12 percent rate of blood transfusions for traditional knee replacements. The transfusions were associated with increased costs of more than $2,200 per incident, longer hospital stays and a higher incidence of complications.¹ In a review of 106 iTotal replacements, including 15 simultaneous bilateral replacements, there were no blood transfusions required. Notably, ConforMIS officials say, 100 percent of patients reported a normal feeling knee only seven months after the procedure. They point to reported dissatisfaction rates ranging from 15-39 percent of knee replacement patients with standard, off-the-shelf implants.^2,3

“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 customized implant, patients will recover faster, quickly return to normal, everyday activities and ultimately forget they even had a knee replacement.”

Recent clinical works include:

• “Early Outcomes Utilizing a First-Generation Customized Patient-Specific TKA Implant” byresearcher William Kurtz, M.D. shared the clinical results of patients implanted with the first-generation customized iTotal implant. In a population of 89 patients and 106 knees treated, no patients required blood transfusions and mean pre-operation range of motion was regained within an average of four months. No patients reported any dissatisfaction in four of five Knee Scoring System categories, including pain while sitting and function while performing recreational activities. As noted above, 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”—Data presented by Gary A. Levengood, M.D., demonstrated that in a population of 63 patients treated with iTotal, 100 percent achieved alignment within ± 2 degrees of the neutral mechanical axis. Restoration of alignment within 3 degrees 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”—Data demonstrated that use of iTotal 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,” researchers reported.

Bedford, Mass.-based ConforMIS is a privately held medical device company that makes patient-specific orthopedic implants and instrumentation. The company’s partial and total knee replacement products include the iUni G2, iDuo G2 and iTotal G2, which are individually designed for each patient. The iUni G2, iDuo G2 and iTotal G2, have been cleared by the U.S. Food and Drug Administration and have CE mark in Europe.

The company claims that potential advantages compared to traditional off-the-shelf implants include faster recovery, shorter hospital stay, less blood loss, more bone preservation, and better functional outcomes with more natural feeling knees.

References:
1 Szubski, et al; National Trends in Utilization and Outcomes of Allogenic Blood Transfusion in Primary Total Knee Arthroplasty, 2000-2009. ISTA Annual Meeting 2013. Poster #2451
2 Hawker, et al; Health-Related Quality of Life after Knee Replacement. Journal of Bone and Joint Surgery; 1998, 80-A #2: 163-173
3 Suda, et al; Are Patients’ Expectations of Hip and Knee Arthroplasty Fulfilled? A Prospective Study of 130 Patients. Orthopedics; 2010, 33 #2: 76-80