A Prospective, Multicenter Study to Evaluate Functional Outcome After Knee Replacement
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Osteoarthritis
- Sponsor
- Restor3D
- Enrollment
- 215
- Locations
- 8
- Primary Endpoint
- Functional Activities Subscale Score Within the Knee Society Score (KSS) Measure
- Status
- Terminated
- Last Updated
- 5 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Functional Activities Subscale Score Within the Knee Society Score (KSS) Measure
Time Frame: 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 Outcomes
- Patient Satisfaction Subscale Score Within the Knee Society Score (KSS) Measure(1 year)
- Incidents of Major Procedure-related and Device Related Complications (Including Revision Rates)(1 year)