ConforMIS: All patients treated with iTotal CR achieve alignment in target rnage
ConforMIS announced the publication of a prospective study in The Journal of Knee Surgery, a peer-reviewed orthopedic journal, on December 14, 2017. The study investigated the ability of the iTotal CR Knee Replacement System restoring coronal plane mechanical axis alignment in a patient's leg. 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. According to the study results, perfect neutral coronal mechanical alignment of 0 degrees was achieved in 84% of patients, with the remaining 16% of patients within +/-2 degrees of neutral. The patients had an average pre-operative deformity of 5.57 degrees , and a post-operative average of 0.18 degrees . Additionally, while 40 of the 63 patients had pre-operative extension deficits, no patients had postoperative extension deficits. According to the study, neutral mechanical limb alignment, or alignment within +/- 3 degrees , 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 Journal of Arthroplasty in 2014, which concluded that the ConforMIS iTotal was 1.8 times more likely to achieve a neutral mechanical alignment as compared to standard off-the-shelf knees. "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."