Knee Prosthesis Clinical Trial
— Sigma MB TKAOfficial title:
In Vivo Mechanics Analysis of Patients Having a Sigma Mobile Bearing TKA
NCT number | NCT01714492 |
Other study ID # | 11019 |
Secondary ID | R01 1373 424 |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 2012 |
Est. completion date | November 2012 |
Verified date | October 2019 |
Source | The University of Tennessee, Knoxville |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Utilize previously developed mathematical model to determine in vivo knee mechanics (kinematics, forces, stresses, areas and sound) for subjects having a Sigma Posterior Stabilizing (PS) mobile bearing (MB) total knee arthroplasty (TKA). There are several hypotheses for this study, although the most prominent is: Subjects having a Sigma RP PS TKA will experience polyethylene bearing rotation at 10 years post-operative, similar to their previous evaluations at six months, two years and five years.
Status | Completed |
Enrollment | 8 |
Est. completion date | November 2012 |
Est. primary completion date | November 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 85 Years |
Eligibility |
Inclusion Criteria: - At least six months post-operative - Between 40-85 years of age - Have a body weight of less than 250 lbs. - Judged clinically successful with a AKS greater than 90 - Have the DePuy Sigma mobile bearing TKA - Good-to-excellent post-operative passive flexion - Must be willing to sign the IC and HIPAA forms. Exclusion Criteria: - Pregnant females - Those not willing to sign the IC and HIPAA forms |
Country | Name | City | State |
---|---|---|---|
United States | Porter Adventist Hospital, Colorado Joint Replacement | Denver | Colorado |
United States | Perkins Hall, The University of Tennessee | Knoxville | Tennessee |
United States | Science and Engineering Research Facility, The University of Tennessee | Knoxville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
The University of Tennessee, Knoxville | DePuy Orthopaedics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | In Vivo Linear Knee Kinematics From Fluoroscopy Evaluation During Deep Knee Bend Activity | The values that were reported indicate the motion of the contact point from full extension to patient's maximum flexion. Throughout flexion, if the point translated forward (anteriorly) atop the tibial tray, the number was reported as positive. If the point traveled backwards (posteriorly) atop the tibial tray, the number was reported as negative. | 10 yrs post-operative | |
Primary | Femoral Axial Rotation With Respect to the Tibia During Deep Knee Bend Activity | 10 yrs post-operative | ||
Primary | Range of Motion During Flexion of Deep Knee Bend Activity | 10 yrs post-operative | ||
Secondary | In Vivo Knee Force Values From Fluoroscopy Evaluation During Deep Knee Bend Activity | The intended unit of measure is "times Body Weight" (or xBW), relating to a ratio. | 10 yrs post-operative | |
Secondary | Condyle Contact Area at Maximum Flexion During Deep Knee Bend Activity | 10 yrs post-operative | ||
Secondary | Condyle Contact Stress at Maximum Flexion During Deep Knee Bend Activity | 10 yrs post-operative |
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