Study Comparing Fit of the iTotal Versus Standard Total Knee Implants
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|ClinicalTrials.gov Identifier: NCT01861028|
Recruitment Status : Terminated (Not enough patient volume to continue the study.)
First Posted : May 23, 2013
Results First Posted : December 28, 2020
Last Update Posted : December 28, 2020
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||44 participants|
|Official Title:||Study Comparing Fit of the iTotal Versus Standard Total Knee Implants|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||December 2015|
A series of 50 consecutive primary iTotal patients will be compared to assess the fit of the tibial tray intra-operatively. These patients will have a series of tibial templates from Standard TKR implant sets trialed on the operative knee. Each template will be optimally sized and positioned based on the surgeon's judgment. Implant fit data (overhang and underhang) on the tibia for all templates will be taken from intra-operative measurements
The Phase I (50 consecutive primary iTotal patients) will also have implant fit data assessed for the femur. After final implantation is complete measurement will be assessed and recorded. A series of 25 primary knees that are scheduled for Standard TKR implants will then undergo the same measurements of the femur.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01861028
|United States, Florida|
|JFK Medical Center|
|Atlantis, Florida, United States, 33462|
|Principal Investigator:||Gregory Martin, MD||JFK Medical Center|