A Multicenter Study to Evaluate Functional Outcome After Knee Replacement
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 800
Summary
- Conditions
- Osteoarthritis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentMasking: Single (Outcomes Assessor)Masking Description: Site staff that is performing functional testing on subject is blinded to what implant the patient has.Primary Purpose: Basic Science
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT02494544
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Mary O'Connor, MD Yale School of Medicine
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