Gait Analysis of a Lateral-Pivot Design Total Knee Replacement

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: t
View:

⁃ Controls:

• At least 50 years of age.

• Subjects who provide signed and IRB approved informed consent for gait analysis data collection

⁃ Retrospective subjects:

• Subjects who had primary total knee replacement with either Stryker Triathlon Total Knee System or Biomet Vanguard Complete Knee System.

• Subjects at least 50 years of age at the time of the surgery.

• Subjects who previously provided signed and informed consent for gait analysis data collection under approval of the Sun Health Institutional Review Board

• Cases that followed product labeling.

⁃ Prospective subjects:

• Subjects who are eligible for DJO Global's Empowr total knee replacement.

• Subjects at least 50 years of age at the time of the surgery.

• Subjects who are willing to provide signed and IRB approved informed consent for gait analysis data collection.

• Cases that followed product labeling.

Locations
United States
Arizona
MORE Foundation
RECRUITING
Phoenix
Contact Information
Primary
John D McCamley, PhD
john.mccamley@more-foundation.org
623.241.5472
Backup
Debra Sietsema, PhD
debra.sietsema@more-foundation.org
623.455.7109
Time Frame
Start Date: 2017-02-02
Estimated Completion Date: 2029-01-02
Participants
Target number of participants: 102
Treatments
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
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
Prospective control subjects
Healthy age matched subjects who did not have any knee osteoarthritis and participated in motion data collections.
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.
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.
Retrospective control subjects
Healthy age matched subjects who did not have any knee osteoarthritis and participated in motion data collections.
Sponsors
Leads: More Foundation
Collaborators: Encore Medical, L.P.

This content was sourced from clinicaltrials.gov