Patients will be consecutively enrolled by implant. Implant groups will be those who have undergone surgery with either a ConforMIS iTotal® CR TKA or an Off-the- Shelf (OTS) system. The patient will conduct functional testing and answer questionnaires. The results will compare the ConforMIS iTotal with an Off the Shelf Knee replacement.
To compare functional and patient reported outcome data for a consecutively enrolled group of subjects who have undergone surgery with either a ConforMIS iTotal® CR TKA or an Off-the- Shelf (OTS) system.The person conducting the functional testing will be blinded to the device implanted. Sites will perform the off-the-shelf total knees conventional instrumentation.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
215
A knee replacement system by DePuy, Zimmer, Biomet, Smith \& Nephew, or Stryker
A knee replacement performed with patient specific implant and surgical jigs.
University of California in San Diego
La Jolla, California, United States
Sharp Healthcare
San Diego, California, United States
Denver-Vail Orthopedics
Parker, Colorado, United States
Yale School of Medicine
New Haven, Connecticut, United States
Functional Activities Subscale Score Within the Knee Society Score (KSS) Measure
Comparing the functional testing differences between iTotal and off the shelf. "Total Functional Activities Score" - a subscale within the Knee Society Score (KSS) with its individual subscale score. The Total Functional Activities Score subscale interprets the functional knee health of each patient via a series of tests such as walking/standing (30 points), standard activities (30 points), advanced activities (25 points), and sports/recreational activities (15 points). Deductions to score are made for factors that limit a patient's mobility, such as needing to use an ambulatory device. The subscale scoring system ranges from 0-100, with higher scores indicating better knee function.
Time frame: 1 year
Patient Satisfaction Subscale Score Within the Knee Society Score (KSS) Measure
Measuring and comparing the differences between iTotal and off the shelf knees with patient reported outcomes. "Patient Satisfaction", a subscale within the Knee Society Score (KSS), was utilized to capture this metric. The Patient Satisfaction subscale combines scores given for certain responses (very satisfied, satisfied, neutral, somewhat dissatisfied, very dissatisfied) across 5 questions. These questions are designed to determine the level of satisfaction a patient has with their implant across both everyday and active activities. This score ranges from 0-40, with higher scores indicating higher levels of patient satisfaction.
Time frame: 1 year
Incidents of Major Procedure-related and Device Related Complications (Including Revision Rates)
All complications were stratified according to clinicaltrials.gov reporting standards and each site labeled each complication as either device-related, non-device-related, procedure-related, and non-procedure-related.
Time frame: 1 year
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Tufts University
Boston, Massachusetts, United States
University of Missouri
Columbia, Missouri, United States
OrthoNY
Albany, New York, United States
The Lindner Center for Research and Education
Cincinnati, Ohio, United States