This study is designed to compare outcome data for patients who have recently undergone surgery with the iTotal® Posterior Stabilizing (PS) Knee Replacement System (hereafter referred to as the "iTotal") versus those who have undergone surgery with Off-the-Shelf (OTS) systems.
This is a prospective, single-time point study that will be conducted in the US.To compare outcomes of these two study groups, this study will include routine office questionnaires such as the Knee Society Score (KSS) and the Knee Injury and Osteoarthritis Outcome Score (KOOS).The functional testing used in this study consists of tests that physical therapists use daily as objective methods to assess patients' functional status. The testing is designed to closely mimic daily activities with which the subjects are familiar.
Study Type
OBSERVATIONAL
Enrollment
31
Total Knee Replacement systems (Patient Specific)
Total Knee Replacement systems (Off-the-shelf)
Bethesda Orthopedic
Bethesda, Maryland, United States
Functional testing differences
Physical therapy functional testing between the iTotal PS and off-the-shelf PS implants
Time frame: At least 6 months post-surgery
Knee Society Clinical Rating Score
Comparison of scores and sub-scores from the following questionnaires between the study arms
Time frame: At least 6 months post-surgery
The Knee Injury and Osteoarthritis Outcome Score (KOOS)
Comparison of scores and sub-scores from the following questionnaires between the study arms
Time frame: At least 6 months post-surgery
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