Study Comparing Fit of the iTotal Versus Standard Total Knee Implants
Overview
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Restor3D
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Phase II: Number of Participants With an Off-the-Shelf Implant Displaying an Overhang of 3 mm or Greater
Overview
Brief Summary
This study compares intraoperative fit of the patient-specific iTotal knee replacement to other standard knee replacement implants
Detailed Description
The study is designed as a single center, two arm analysis. The study will be completed in two phases, based on measurement type.
All additional data will be obtained from pre and post-operative subject surveys, operative and discharge records and radiographs.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients who are scheduled for a standard total knee replacement
- •Patient who are scheduled for patient-specific total knee replacement (iTotal)
- •Patient age \> 18 years
Exclusion Criteria
- •Patients who do not receive a total knee replacement
- •Unwilling or unable to comply with study requirements
Outcomes
Primary Outcomes
Phase II: Number of Participants With an Off-the-Shelf Implant Displaying an Overhang of 3 mm or Greater
Time Frame: Intraoperatively, up to 120 minutes
Fit will be measured in 3 quadrants on the tibia using a ruler to measure the distance between the off-the-shelf design and the edge of the tibia.
Phase I: Number of Participants With a Customized Tibia Implant Displaying an Overhang of 3 mm or Greater
Time Frame: Intraoperatively, up to 120 minutes
Fit will be measured in 4 quadrants on the tibia using a ruler to measure the distance between the customized implant and the edge of the tibia.
Secondary Outcomes
No secondary outcomes reported