Study Comparing Fit of the iTotal Versus Standard Total Knee Implants

Terminated

• Conditions: Osteoarthritis

• Registration Number: NCT01861028
• Lead Sponsor: Restor3D

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 Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-03-26
• Study First Submitted QC: 2013-05-21
• Study First Posted: 2013-05-23
• Primary Completion: 2015-09
• Study Completion: 2015-12
• Results First Submitted: 2019-07-16
• Results First Submitted QC: 2020-12-02
• Results First Posted: 2020-12-28
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-23
• Last Update Posted: 2023-10-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

JFK Medical Center; 🇺🇸 Atlantis, Florida, United States