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NCT00894361 · ClinicalTrials.gov registry record · Phase 4
Comparison of Mobile-Bearing and Fixed-Bearing All-Polyethylene Tibia Total Knee Designs
A Phase 4 study, sponsored by Minneapolis Veterans Affairs Medical Center.
- Terminated
- Registry status
- Phase 4
- Development phase
- 400
- Enrollment target
NCT00894361 is a Phase 4 study that was terminated before completion, run by Minneapolis Veterans Affairs Medical Center. The registered enrollment target is 400 participants.
The verdict
NCT00894361, a Phase 4 study, was terminated before completion, sponsored by Minneapolis Veterans Affairs Medical Center.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 400 participants
- Enrollment target
Study Summary
This study will be designed to compare prospectively, in a randomized fashion, the clinical, functional, and radiographic results of a nonmodular (all-polyethylene tibi/AP) fixed-bearing posterior cruciate substituting design with a modular posterior cruciate substituting rotating platform (RP) design for total knee arthroplasty. Comparing these two designs will afford the investigators information in the following areas: 1. Does a RP design offer improvement in range of motion over a AP design? 2. Does a RP design have improved wear characteristics over a nonmodular AP design? 3. Is there a clear clinical advantage to the RP design that justifies its increased cost? Answering these questions will allow surgeons to use RP designs appropriately in different demand populations. This study was designed to address the questions of whether an RP design offers improvement in ROM, Knee Society scores, Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) scores, selected Medical Outcomes Short-Form Health Survey Short Form-36 (SF-36) scores or radiographic measures, over an APT design. The investigators' primary hypothesis was that there would be no difference in these outcome measures at a minimum two year followup. A secondary hypothesis based on the anticipated long-term followup of this group was that there would be no difference in implant survival.
Interventions
- PROCEDURE TKA surgery with the rotating platform mobile-bearing knee design
- PROCEDURE TKA surgery with the all-polyethylene tibia knee design
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2001-10 |
| Est. Completion | 2007-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00894361
The ClinicalTrials.gov registry entry for NCT00894361 describes a study currently listed as terminated, categorized as Phase 4. 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 2 interventions - of which TKA surgery with the rotating platform mobile-bearing knee design is the first listed.
NCT00894361 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00894361 about?
NCT00894361 is a clinical study titled "Comparison of Mobile-Bearing and Fixed-Bearing All-Polyethylene Tibia Total Knee Designs". This study will be designed to compare prospectively, in a randomized fashion, the clinical, functional, and radiographic results of a nonmodular (all-polyethylene tibi/AP) fixed-bearing posterior cruciate substituting design with a modular posterior cruciate substituting rotating platform (RP) desi...
What is the current status of trial NCT00894361?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 400 participants. The study started on 2001-10. Estimated completion is 2007-01.
What interventions are being tested in trial NCT00894361?
The interventions under investigation include: TKA surgery with the rotating platform mobile-bearing knee design (PROCEDURE), TKA surgery with the all-polyethylene tibia knee design (PROCEDURE).
Who is sponsoring clinical trial NCT00894361?
This trial is sponsored by Minneapolis Veterans Affairs Medical Center, which has 28 total clinical trials registered on ClinicalTrials.gov.
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