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A Single Time-Point Study to Evaluate the ConforMIS iTotal (PS) Knee Replacement System Versus Off-the-Shelf

NCT03146819 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 31

Last updated 2023-10-25

No results posted yet for this study

Summary

This study is designed to compare outcome data for patients who have recently undergone surgery with the iTotal® Posterior Stabilizing (PS) Knee Replacement System (hereafter referred to as the "iTotal") versus those who have undergone surgery with Off-the-Shelf (OTS) systems.

Conditions

  • Osteoarthritis, Knee

Interventions

DEVICE

iTotal PS Knee Replacement System

Total Knee Replacement systems (Patient Specific)

DEVICE

Off-the-Shelf Knee Replacement System

Total Knee Replacement systems (Off-the-shelf)

Sponsors & Collaborators

  • Restor3D

    lead INDUSTRY

Principal Investigators

  • Christopher Cannova, MD · Bethesda Orthopedic

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-16
Primary Completion
2017-05-31
Completion
2017-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT03146819 on ClinicalTrials.gov