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NCT01714492 · ClinicalTrials.gov registry record
Mechanics Analysis of Patients Having a Sigma Mobile Bearing TKA
A clinical trial of Knee Replacement Arthroplasty and Knee Prosthesis, sponsored by The University of Tennessee, Knoxville.
- Completed
- Registry status
- 8
- Enrollment target
- 3
- Study locations
NCT01714492: Completed study of Knee Replacement Arthroplasty and Knee Prosthesis, sponsored by The University of Tennessee, Knoxville.
NCT01714492 is a study of Knee Replacement Arthroplasty and Knee Prosthesis that has completed, run by The University of Tennessee, Knoxville. The registered enrollment target is 8 participants. The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01714492, a study of Knee Replacement Arthroplasty and Knee Prosthesis, has completed, sponsored by The University of Tennessee, Knoxville.
- COMPLETED
- Registry status
- 8 participants
- Enrollment target
- 3
- Study locations
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly
Study Locations (3)
Tennessee
- Perkins Hall, The University of Tennessee - Knoxville
- Science and Engineering Research Facility, The University of Tennessee - Knoxville
Colorado
- Porter Adventist Hospital, Colorado Joint Replacement - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2012-04 |
| Est. Completion | 2012-11 |
What the finished NCT01714492 record still lists
NCT01714492 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 8 participants, a relatively small participant target.
The record links to 2 conditions, with Knee Replacement Arthroplasty appearing as the primary indexed condition, and to 1 intervention - of which Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly is the first listed.
NCT01714492 reports a single indexed study location in Tennessee, Colorado.
Frequently Asked Questions
What is clinical trial NCT01714492 about?
NCT01714492 is a clinical study titled "Mechanics Analysis of Patients Having a Sigma Mobile Bearing TKA". 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...
What is the current status of trial NCT01714492?
This trial is currently completed. The enrollment target is 8 participants. The study started on 2012-04. Estimated completion is 2012-11.
What conditions does trial NCT01714492 study?
This clinical trial studies the following conditions: Knee Replacement Arthroplasty, Knee Prosthesis.
What interventions are being tested in trial NCT01714492?
The interventions under investigation include: Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly (DEVICE).
Who is sponsoring clinical trial NCT01714492?
This trial is sponsored by The University of Tennessee, Knoxville, which has 81 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01714492 being conducted?
This trial has 3 study locations across Colorado, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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