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Gait Analysis of a Lateral-Pivot Design Total Knee Replacement

NCT04275362 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 102

Last updated 2022-05-06

No results posted yet for this study

Summary

Previous motion analysis studies have demonstrated excellent ability to distinguish subtle differences in gait between normal subjects and those suffering from arthritis. With proper techniques and analysis differences between osteoarthritis patient groups can be distinguished. Previous research has indicated that subjects who received a single-radius design total knee replacement have superior gait performance that those who received a multi-radius design total knee replacement. The DJO Global Empowr PS Knee System is a single-radius lateral pivot design. This design should achieve reproducible more natural knee function and improved patient outcomes and satisfaction. A motion analysis laboratory will be used to collect gait data from patients who are going to receive a Empowr PS knee device and also from age-matched control subjects. These data will be compared with data previously collected from patients who received Stryker Triathlon devices, Biomet Vanguard devices and age-matched healthy control subjects.

Conditions

Interventions

DEVICE

DJO Empowr PS Knee System

Patients will receive a DJO Empowr PS Knee System total knee replacement

DEVICE

Stryker Triathlon Total Knee System

Patients received a Stryker Triathlon Total Knee System total knee replacement

DEVICE

Biomet Vanguard Complete Knee System

Patients received a Biomet Vanguard Complete Knee System total knee replacement

DEVICE

Control

No total knee replacement

Sponsors & Collaborators

  • Encore Medical, L.P.

    collaborator INDUSTRY

  • More Foundation

    lead OTHER

Principal Investigators

  • Scott Siverhus, MD · The CORE Institute

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-02
Primary Completion
2023-04-02
Completion
2029-01-02
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 NCT04275362 on ClinicalTrials.gov