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NCT00979147 · ClinicalTrials.gov registry record · NA
Comparison of a Metal Backed Fixed-Bearing Tibial Baseplate and an All-Polyethylene Tibia in Total Knee Arthroplasty
A NA study, sponsored by Minneapolis Veterans Affairs Medical Center.
- Terminated
- Registry status
- NA
- Development phase
- 400
- Enrollment target
NCT00979147 is a NA study that was terminated before completion, run by Minneapolis Veterans Affairs Medical Center. The registered enrollment target is 400 participants.
The verdict
NCT00979147, a NA study, was terminated before completion, sponsored by Minneapolis Veterans Affairs Medical Center.
- TERMINATED
- Registry status
- NA
- Development phase
- 400 participants
- Enrollment target
Study Summary
This study is designed to compare prospectively, in a randomized Level 1 evidence fashion, the clinical, functional, and radiographic results of a modular polished tibial (MPT) tray with a moderately cross-linked polyethylene (XLK) insert to an all-polyethylene tibial (APT) design with GVF polyethylene. Comparing these two designs will afford us information in the following areas: 1. Does a MPT/XLK design have improved wear characteristics over a nonmodular APT/GVF design? 2. Is there a clear clinical advantage to the MPT/XLK design in certain patient populations that justify its use over the APT/GVF design? Answering these questions will allow surgeons to use both designs appropriately in different demand populations. This study is designed to address the questions of whether an MPT/XLK design offers improvement in wear characteristics, Knee Society scores, KOOS, WOMAC, SF-36, or radiographic measures, over an APT design. The investigator's primary hypothesis is that there will be no difference in these outcome measures at a minimum two year follow-up. A secondary hypothesis based on the long-term follow-up of this group, up to twenty years, is that there will be no difference in implant survival.
Interventions
- PROCEDURE TKA surgery with modular polished tibial baseplate/XLK design
- PROCEDURE TKA surgery with the nonmodular APT/GVF design
- DEVICE P.F.C.® Sigma Knee System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2007-11 |
| Est. Completion | 2013-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00979147
The ClinicalTrials.gov registry entry for NCT00979147 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Minneapolis Veterans Affairs Medical Center, which has 28 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which TKA surgery with modular polished tibial baseplate/XLK design is the first listed.
NCT00979147 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00979147 about?
NCT00979147 is a clinical study titled "Comparison of a Metal Backed Fixed-Bearing Tibial Baseplate and an All-Polyethylene Tibia in Total Knee Arthroplasty". This study is designed to compare prospectively, in a randomized Level 1 evidence fashion, the clinical, functional, and radiographic results of a modular polished tibial (MPT) tray with a moderately cross-linked polyethylene (XLK) insert to an all-polyethylene tibial (APT) design with GVF polyethyl...
What is the current status of trial NCT00979147?
This trial is currently terminated. It is a NA study. The enrollment target is 400 participants. The study started on 2007-11. Estimated completion is 2013-11.
What interventions are being tested in trial NCT00979147?
The interventions under investigation include: TKA surgery with modular polished tibial baseplate/XLK design (PROCEDURE), TKA surgery with the nonmodular APT/GVF design (PROCEDURE), P.F.C.® Sigma Knee System (DEVICE).
Who is sponsoring clinical trial NCT00979147?
This trial is sponsored by Minneapolis Veterans Affairs Medical Center, which has 28 total clinical trials registered on ClinicalTrials.gov.
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