Study Comparing Fit of the iTotal Versus Standard Total Knee Implants

Restor3D44 enrolled

Overview

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

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

Enrollment

Conditions

Osteoarthritis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

JFK Medical Center

Atlantis, Florida, United States

Outcomes

Primary Outcomes

Phase I: Number of Participants With a Customized Tibia Implant Displaying an Overhang of 3 mm or Greater

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.

Time frame: Intraoperatively, up to 120 minutes

Phase II: Number of Participants With an Off-the-Shelf Implant Displaying an Overhang of 3 mm or Greater

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.

Time frame: Intraoperatively, up to 120 minutes

Data from ClinicalTrials.gov

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