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The study, which was independently performed by Dr. Gary Levengood at Sports Medicine South in Lawrenceville, Georgia, examined 63 consecutive patients he operated on using the ConforMIS iTotal CR implant system and ConforMIS iJig patient-specific instrumentation. Results in each of the cases were verified using computer-assisted surgery (CAS). According to the study results, perfect neutral coronal mechanical alignment of 0° was achieved in 84% of patients, with the remaining 16% of patients within +/-2° of neutral. The patients had an average pre-operative deformity of 5.57° (range 12° valgus to 15°varus), and a post-operative average of 0.18° (range 0-2°) (p<0.0001). Additionally, while 40 of the 63 patients had pre-operative extension deficits (the inability to fully extend the leg), no patients had postoperative extension deficits.
According to the study, neutral mechanical limb alignment, or alignment within +/- 3°, has previously been linked to better survivorship in TKA, while poor alignment has been linked to higher rates of implant failure. This study’s findings are consistent with those of a previous published study by Ivie et.al. from the
Based on a review of the published literature, the authors reported that the results observed with the ConforMIS iTotal CR patient-specific, custom-made total knee implant with patient-specific instrumentation were found to be more consistently accurate than previous reports on patient-specific cutting guides used with standard off-the-shelf implants. The authors noted that, according to the literature, patient-specific cutting guides used with standard off-the-shelf implants resulted in a high percentage of cases with an overall error in mechanical axis alignment greater than a threshold of 3 degrees. The authors of the study suggest several key differences that may have contributed to the greater accuracy of the iTotal system with its iJig instrumentation compared with the published literature, including the use of a full set of ConforMIS patient-specific jigs with the ConforMIS custom-made implant, and the ability to maintain native medial and lateral offsets of the femur.
“As a surgeon, one of the most important goals to me with any knee replacement, is to achieve a neutral mechanical limb alignment. The inherent variability noted in the literature when using patient-specific jigs with an off-the-shelf implant, where the mechanical alignment too often fell outside of the +/- 3° acceptable range, was the impetus in studying this metric as I began to use this iTotal technology,” said Dr Levengood. “As our data shows, we were able to achieve precise alignment, with absolutely no outliers. Prior to using the ConforMIS iTotal CR, I utilized computer navigation to achieve a reproducible alignment; however, this added substantial time to my procedures and required surgical placement of tracking pins in each patient's femur and tibia during the operation. With the iTotal, I am provided a complete operative plan, from the CT scan each patient gets prior to surgery. Based on these results, I have full confidence in the system to deliver consistent and improved surgical outcomes.”
“This independent study provides compelling new data demonstrating the accuracy of utilizing ConforMIS iJig instrumentation, with its built-in mechanical axis alignment and image guidance, in combination with our individually designed, patient-specific implants,” said Mark Augusti, Chief Executive Officer and President of ConforMIS. “Importantly, it is consistent with earlier published results. One of the drawbacks of patient-specific cutting guides when used with standard off-the-shelf implants that are not patient-specific has been the inability to consistently achieve neutral mechanical alignment. Dr. Levengood’s data demonstrate that the ConforMIS iTotal CR system does not share this problem. This study adds enlightening data and analysis to the growing body of evidence that ConforMIS iJig Instrumentation, when used in conjunction with ConforMIS individually designed, patient-specific iTotal implants, provides superior results compared to other patient-specific instrumentation used with off-the-shelf implants.”
ConforMIS did not provide any economic support for this study. Dr. Levengood previously has served as an advisor to ConforMIS.
ConforMIS is a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are individually sized and shaped, or customized, to fit each patient’s unique anatomy. ConforMIS offers a broad line of customized knee implants and pre-sterilized, single-use instruments delivered in a single package to the hospital. In recent clinical studies, ConforMIS iTotal CR demonstrated superior clinical outcomes, including better function and greater patient satisfaction, compared to traditional, off-the-shelf implants. ConforMIS owns or exclusively in-licenses approximately 420 issued patents and pending patent applications that cover customized implants and patient-specific instrumentation for all major joints.
For more information, visit www.conformis.com.
Cautionary Statement Regarding Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for ConforMIS, including statements about the potential clinical benefits or other impacts and advantages of using customized implants, as well as other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar expressions, constitute forward-looking statements within the meaning of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of a variety of risks and uncertainties, including risks related to our clinical studies, and the other risks and uncertainties described in the “Risk Factors” sections of our public filings with the
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A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/cb3cb524-e1b7-4e82-a02a-4d4dadbc0177