Gait Analysis of a Lateral-Pivot Design Total Knee Replacement
Eligible age
50+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
Yes
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About this study
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.
Sponsor: More Foundation
You may qualify if…
- ✓ Controls:
- ✓ 1. At least 50 years of age.
- ✓ 2. Subjects who provide signed and IRB approved informed consent for gait analysis data collection
- ✓ Retrospective subjects:
- ✓ 1. Subjects who had primary total knee replacement with either Stryker Triathlon Total Knee System or Biomet Vanguard Complete Knee System.
- ✓ 2. Subjects at least 50 years of age at the time of the surgery.
- ✓ 3. Subjects who previously provided signed and informed consent for gait analysis data collection under approval of the Sun Health Institutional Review Board
- ✓ 4. Cases that followed product labeling.
You may not qualify if…
- ✕ Controls:
- ✕ 1. Controls with any musculoskeletal injury or disorder.
- ✕ 2. Controls that are pregnant or planning on becoming pregnant.
- ✕ 3. Controls with a BMI\>40
- ✕ Retrospective subjects:
- ✕ 1. Subjects with inflammatory arthritis or psoriatic arthritis at the time of surgery.
- ✕ 2. Subjects that are pregnant or planning on becoming pregnant.
- ✕ 3. Subjects with a BMI\>40
Where it's recruiting
Phoenix
Source: ClinicalTrials.gov · NCT04275362 · last updated 2022-05-06