Clinical Study Results: ConforMIS iTotal CR Customized Knees
Results from an independent, prospective, single-center, 62-patient investigator-initiated study indicate that total knee patients receiving ConforMIS iTotal CR outperformed recipients of off-the-shelf implants in terms of length of stay, discharge within 24 hours, discharge to home vs. SNF, etc.
Specifically, the study of investigated 62 total knee replacement patients in “fast track” surgeries, receiving either an iTotal CR or a traditional implant.
iTotal CR patients logged a significantly shorter length of stay vs. off-the-shelf patients (1.6 days vs. 2.7 days); more were discharged within 24 hours (66% vs. 30%) with a significantly higher proportion of iTotal discharges directly to home (97% vs. 80%) as opposed to a skilled nursing facility (SNF). Further, a significantly higher proportion of iTotal patients achieved range of motion greater than or equal to 120 degrees (84% vs. 45%).
Based on the results of the study and other published economic data, the clinical investigator concluded that the iTotal CR has the potential to save hospitals approximately $2,200 per patient, taking into account in-hospital cost savings and costs to discharge to an SNF.
Separately, an update to an ongoing multi-center prospective study of 740 consecutively-enrolled total knee replacement patients showed that iTotal CR implant recipients were significantly significantly faster than off-the-shelf implant patients in walking, getting in and out of a chair and navigating stairs.
The first iTotal CR iteration launched in 2011, followed by the next-gen version in 2015. ConforMIS' clinical activity has continued apace since 2014. In July, interim results from a U.S. 300+ patient multi-center prospective study of iTotal CR indicated that 92% of patients were satisfied, on average, at one year.
Sources: ConforMIS, Inc.; ORTHOWORLD Inc.