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NCT01290640 · ClinicalTrials.gov registry record
Comparison of Kinematics for Subjects Implanted With a PFC Sigma Rotating Platform or Fixed Bearing TC3 Prosthesis
A clinical trial, sponsored by The University of Tennessee, Knoxville.
- Completed
- Registry status
- 22
- Enrollment target
NCT01290640: Completed study, sponsored by The University of Tennessee, Knoxville.
NCT01290640 is a clinical trial that has completed, run by The University of Tennessee, Knoxville. The registered enrollment target is 22 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01290640 has completed, sponsored by The University of Tennessee, Knoxville.
- COMPLETED
- Registry status
- 22 participants
- Enrollment target
Study Summary
The objectives of this study are four-fold: 1. To determine the three-dimensional, in vivo kinematics for subjects having either a fixed- or mobile-bearing Press Fit Condylar (PFC) Sigma Total Condylar III Prosthesis, comparing the in vivo kinematics to determine if one implant type leads to a benefit for the patient. 2. To determine if bearing mobility occurs in PFC Sigma Rotating Platform Total Condylar III Prosthesis under in vivo, weight-bearing conditions during multiple activities (gait, stair descent, deep knee bend and chair rise). 3. To determine if there is a correlation between in vivo kinematic data obtained using fluoroscopy, electromyography (EMG) and ground reaction force (GRF) data and determine if variability occurs between these two TKA types. 4. To determine if a clinical benefit is either visibly detected (video camera) or quantifiably determined (questionnaire) for either TKA type.
Primary Outcome
The values that were reported indicate the motion of the contact point from the start of the activity to the end of the activity. 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.
Interventions
- DEVICE DePuy fixed-bearing Total Condylar III (TC3) TKA
- DEVICE DePuy PFC Rotating Platform TC3 TKA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2011-02 |
| Est. Completion | 2013-02 |
What the finished NCT01290640 record still lists
NCT01290640 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 22 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which DePuy fixed-bearing Total Condylar III (TC3) TKA is the first listed.
NCT01290640 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01290640 about?
NCT01290640 is a clinical study titled "Comparison of Kinematics for Subjects Implanted With a PFC Sigma Rotating Platform or Fixed Bearing TC3 Prosthesis". The objectives of this study are four-fold: 1. To determine the three-dimensional, in vivo kinematics for subjects having either a fixed- or mobile-bearing Press Fit Condylar (PFC) Sigma Total Condylar III Prosthesis, comparing the in vivo kinematics to determine if one implant type leads to a bene...
What is the current status of trial NCT01290640?
This trial is currently completed. The enrollment target is 22 participants. The study started on 2011-02. Estimated completion is 2013-02.
What interventions are being tested in trial NCT01290640?
The interventions under investigation include: DePuy fixed-bearing Total Condylar III (TC3) TKA (DEVICE), DePuy PFC Rotating Platform TC3 TKA (DEVICE).
Who is sponsoring clinical trial NCT01290640?
This trial is sponsored by The University of Tennessee, Knoxville, which has 81 total clinical trials registered on ClinicalTrials.gov.
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