Study Comparing Fit of the iTotal Versus Standard Total Knee Implants

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2015-12-31

Brief Summary

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This study compares intraoperative fit of the patient-specific iTotal knee replacement to other standard knee replacement implants

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Detailed Description

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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.

Conditions

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Osteoarthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Phase I

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

No interventions assigned to this group

Phase II

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.

No interventions assigned to this group

Eligibility Criteria

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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