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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 is a clinical trial that has completed, run by The University of Tennessee, Knoxville. The registered enrollment target is 22 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01290640
The ClinicalTrials.gov registry entry for NCT01290640 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Tennessee, Knoxville, which has 81 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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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