Study Comparing Fit of the iTotal Versus Standard Total Knee Implants
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|ClinicalTrials.gov Identifier: NCT01861028|
Recruitment Status : Unknown
Verified June 2015 by ConforMIS, Inc..
Recruitment status was: Recruiting
First Posted : May 23, 2013
Last Update Posted : June 19, 2015
|Condition or disease|
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 Type :||Observational|
|Estimated Enrollment :||75 participants|
|Official Title:||Study Comparing Fit of the iTotal Versus Standard Total Knee Implants|
|Study Start Date :||February 2013|
|Estimated Primary Completion Date :||September 2015|
|Estimated 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.
- Tibial and Femoral Implant Fit [ Time Frame: Intraoperatively ]
Fit will be measured in 5 quadrants on the tibia using a ruler to measure the distance between the implant and the edge of the tibia.
Fit will be measured in the Medial-lateral dimension on both condyles on the femur in 5 or 6 different zones, depending on whether the femoral implant has 5 or 6 facets. Measurements will also be done in mm.
- Knee Society Score [ Time Frame: 1 Year ]
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||Recruiting|
|Atlantis, Florida, United States, 33462|
|Contact: Jamie Kosik 561-548-1414 Jamie.Kosik@hcahealthcare.com|
|Principal Investigator: Gregory Martin, MD|
|Principal Investigator:||Gregory Martin, MD||JFK Medical Center|