A Multicenter Study to Evaluate Functional Outcome After Knee Replacement
- Conditions
- Osteoarthritis
- Registration Number
- NCT02494544
- Lead Sponsor
- Restor3D
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 215
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Primary Outcome Measures
Name Time Method Functional Activities Subscale Score Within the Knee Society Score (KSS) Measure 1 year 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.
- Secondary Outcome Measures
Name Time Method Patient Satisfaction Subscale Score Within the Knee Society Score (KSS) Measure 1 year 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.
Trial Locations
- Locations (8)
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
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
University of California in San Diego🇺🇸La Jolla, California, United States