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A Multicenter Study to Evaluate Functional Outcome After Knee Replacement

NCT02494544 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 215

Last updated 2025-11-21

Study results available
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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.

Conditions

Interventions

DEVICE

Off the Shelf Total Knee Replacement

A knee replacement system by DePuy, Zimmer, Biomet, Smith \& Nephew, or Stryker

DEVICE

ConforMIS iTotal Knee Replacement

A knee replacement performed with patient specific implant and surgical jigs.

Sponsors & Collaborators

  • Restor3D

    lead INDUSTRY

Principal Investigators

  • Mary O'Connor, MD · Yale University

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-01
Primary Completion
2022-11-16
Completion
2022-11-16
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02494544 on ClinicalTrials.gov