Actively Recruiting
Gait Analysis of a Lateral-Pivot Design Total Knee Replacement
Led by More Foundation · Updated on 2022-05-06
102
Participants Needed
1
Research Sites
621 weeks
Total Duration
On this page
Sponsors
M
More Foundation
Lead Sponsor
E
Encore Medical, L.P.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Gait Analysis of a Lateral-Pivot Design Total Knee Replacement
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Controls must be at least 50 years old and provide signed informed consent for gait analysis data collection
- Retrospective subjects must have had primary total knee replacement with Stryker Triathlon or Biomet Vanguard systems
- Retrospective subjects must be at least 50 years old at time of surgery
- Retrospective subjects must have provided signed informed consent for gait analysis data collection under IRB approval
- Retrospective cases must have followed product labeling
- Prospective subjects must be eligible for DJO Global's Empowr total knee replacement
- Prospective subjects must be at least 50 years old at time of surgery
- Prospective subjects must be willing to provide signed informed consent for gait analysis data collection
- Prospective cases must have followed product labeling
You will not qualify if you...
- Controls with any musculoskeletal injury or disorder
- Controls who are pregnant or planning to become pregnant
- Controls with a body mass index (BMI) over 40
- Retrospective subjects with inflammatory arthritis or psoriatic arthritis at time of surgery
- Retrospective subjects who are pregnant or planning to become pregnant
- Retrospective subjects with a BMI over 40
- Retrospective subjects with active or suspected latent infection in or about the joint at time of surgery
- Retrospective subjects with compromised bone stock that cannot support or fix the prosthesis
- Retrospective subjects with mental or neuromuscular disorders posing risk to prosthesis stability or postoperative care
- Retrospective subjects with severe knee joint instability due to absence of collateral ligament integrity and function
- Prospective subjects with inflammatory arthritis or psoriatic arthritis at time of surgery
- Prospective subjects who are pregnant or planning to become pregnant
- Prospective subjects with a BMI over 40
- Prospective subjects with active or suspected latent infection in or about the joint at time of surgery
- Prospective subjects with compromised bone stock that cannot support or fix the prosthesis
- Prospective subjects with mental or neuromuscular disorders posing risk to prosthesis stability or postoperative care
- Prospective subjects with severe knee joint instability due to absence of collateral ligament integrity and function
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
MORE Foundation
Phoenix, Arizona, United States, 85023
Actively Recruiting
Research Team
J
John D McCamley, PhD
CONTACT
D
Debra Sietsema, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
6
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