Study Comparing Fit of the iTotal Versus Standard Total Knee Implants

Osteoarthritis Clinical Trial

Official title:

Study Comparing Fit of the iTotal Versus Standard Total Knee Implants

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01861028
• Other study ID #: 12-002
• Status: Terminated
• Start date: February 2013
• Est. completion date: December 2015

Study information

• Verified date: October 2023
• Source: Restor3D
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 44
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Locations

Country	Name	City	State
United States	JFK Medical Center	Atlantis	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Restor3D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Intraoperatively, up to 120 minutes
Primary	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.	Intraoperatively, up to 120 minutes