A Multicenter Study to Evaluate Functional Outcome After Knee Replacement

Not Applicable

Terminated

• Conditions: Osteoarthritis

• Registration Number: NCT02494544
• Lead Sponsor: Restor3D

Brief Summary

Patients will be consecutively enrolled by implant. Implant groups will be those who have undergone surgery with either a ConforMIS iTotal® CR TKA or an Off-the- Shelf (OTS) system.

The patient will conduct functional testing and answer questionnaires.

The results will compare the ConforMIS iTotal with an Off the Shelf Knee replacement.

Detailed Description

To compare functional and patient reported outcome data for a consecutively enrolled group of subjects who have undergone surgery with either a ConforMIS iTotal® CR TKA or an Off-the- Shelf (OTS) system.The person conducting the functional testing will be blinded to the device implanted. Sites will perform the off-the-shelf total knees conventional instrumentation.

Study Timeline

• Study First Submitted: 2015-05-28
• Study Start: 2015-07-01
• Study First Submitted QC: 2015-07-09
• Study First Posted: 2015-07-10
• Primary Completion: 2022-11-16
• Study Completion: 2022-11-16
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-23
• Last Update Posted: 2023-10-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 187

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Functional Testing	1 year	Comparing the functional testing differences between iTotal and off the shelf

Secondary Outcome Measures

Name	Time	Method
Patient reported outcome using questionnaires such as the KOOS and VAS	1 year	Measuring and comparing the differences between iTotal and off the shelf knees with patient reported outcomes.
Incidents of major procedure-related and device related complications (including revision rates)	1 year	To compare revision rates between groups
Post-operative limb alignment based using x-ray views	1 year	To compare post-operative limb alignment between two groups

Trial Locations

Locations (8)

University of California in San Diego; 🇺🇸 La Jolla, California, United States

Sharp Healthcare; 🇺🇸 San Diego, California, United States

Denver-Vail Orthopedics; 🇺🇸 Parker, Colorado, United States

Yale School of Medicine; 🇺🇸 New Haven, Connecticut, United States

Tufts University; 🇺🇸 Boston, Massachusetts, United States

University of Missouri; 🇺🇸 Columbia, Missouri, United States

OrthoNY; 🇺🇸 Albany, New York, United States

The Lindner Center for Research and Education; 🇺🇸 Cincinnati, Ohio, United States