Gait Analysis of a Lateral-Pivot Design Total Knee Replacement

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
More Foundation
Study ID
NCT04275362
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • DJO Empowr PS Knee System — DEVICE
    Patients will receive a DJO Empowr PS Knee System total knee replacement
  • Stryker Triathlon Total Knee System — DEVICE
    Patients received a Stryker Triathlon Total Knee System total knee replacement
  • Biomet Vanguard Complete Knee System — DEVICE
    Patients received a Biomet Vanguard Complete Knee System total knee replacement
  • Control — DEVICE
    No total knee replacement

Study Details

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.

Key Dates

Start date
Feb 2, 2017
Status verified
May 2022
Primary completion
Apr 2, 2023
Completion
Jan 2, 2029

Study Design

Enrollment
102 participants (estimated)

Arms

  • Arm: DJO subjects for surgical technique
    Subjects who meet the inclusion criteria and receive a DJO Empowr total knee replacement but will not participate in motion data collection
  • Arm: DJO subjects for data collection
    Subjects who meet the inclusion criteria and consent to be in the study will receive a DJO Empowr total knee replacement and participate in motion data collections at pre-op, and 6 and 12 months post-op. Subjects will also participate in pre-op, 6 month, 1 year, 2 year, 5 year, and 10 year post-op clinical data collections
  • Arm: Prospective control subjects
    Healthy age matched subjects who did not have any knee osteoarthritis and participated in motion data collections.
  • Arm: Stryker TKA subjects
    Subjects who met the inclusion criteria and consented to be in a study whereby they received a Stryker Triathlon total knee replacement and participated in motion analysis pre-surgery and 6 and 12 months post-surgery.
  • Arm: Biomet TKA subjects
    Subjects who met the inclusion criteria and consented to be in a study whereby they received a Biomet Vanguard total knee replacement and participated in motion analysis pre-surgery and 12 months post-surgery.
  • Arm: Retrospective control subjects
    Healthy age matched subjects who did not have any knee osteoarthritis and participated in motion data collections.

Primary Outcome Measure

Knee flexion angle during swing [ Time Frame: Pre-op ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MORE FoundationPhoenixArizona85023
John D McCamley, PhD
[email protected]
623-241-8721
Debra Sietsema, PhD
[email protected]
623.455.7109

Find similar trials in Phoenix, AZ

By condition
Osteoarthritis (other)
By specialty
OrthopedicsMusculoskeletal disorders
By research site
MORE Foundation· Phoenix, AZ

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