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NCT00589147 · ClinicalTrials.gov registry record · NA
A Prospective, Randomized, Controlled Study Comparing Three Tibial Component Designs in Total Knee Arthoplasty
A NA study, sponsored by Mayo Clinic.
- Completed
- Registry status
- NA
- Development phase
- 397
- Enrollment target
NCT00589147: Completed NA study, sponsored by Mayo Clinic.
NCT00589147 is a NA study that has completed, run by Mayo Clinic. The registered enrollment target is 397 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00589147, a NA study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 397 participants
- Enrollment target
Study Summary
SUMMARY A prospective, randomized, single-blinded clinical trial is proposed to compare three tibial tray designs for patients undergoing total knee arthroplasty. This study is designed to address the clinically important issues of tibial component modularity and fixation in total knee replacement. The Zimmer NexGen Legacy knee system is an FDA approved device and in this study will be used with 1) a modular tibial tray inserted with cement and 2) a non-modular tibial tray inserted with cement, and 3) a non-modular tibial tray inserted without cement. The insertion of total knee components without cement has been done clinically for over 20 years but has not been specifically approved by the FDA. Thus treatment arm 3, a non-modular tray inserted without cement, would involve the so-called off-label use of the device. 136 cases will be assigned to each arm of the study. Each patient will be assessed two months after surgery, one year after surgery, two years after surgery, five years after surgery, and every three to five years thereafter. The principal outcome measures will be the Knee Society Clinical rating scale, the SF-36 and the presence of significant lucent lines.. These measures will be compared among patients in the 3 trial arms at 5 years post surgery (or at the last follow-up point for those who drop out or become lost to follow-up). The Knee Society scores and SF-36 scores will be analyzed using analysis of variance models Rates of significant lucencies, perioperative mortality, as well as complications such as deep vein thrombosis, pulmonary embolus, neurovascular complication, and infection will be compared among the groups using chi-square tests . Rates of revision surgery will be compared among the groups using survivorship methods. PURPOSE The primary aim of the study is to compare the results obtained with each of three tibial designs for patients undergoing total knee arthroplasty. Those results will be measured with disease-specific (Knee Socie
Interventions
- DEVICE The Zimmer NexGen Legacy Knee System, modular cemented tibia
- DEVICE The Zimmer NexGen Legacy Knee System, non-modular cemented tibia.
- DEVICE The Zimmer NexGen Legacy Knee System, non-modular uncemented tibia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 397 participants |
| Start Date | 2003-08 |
| Est. Completion | 2007-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00589147
The ClinicalTrials.gov registry entry for NCT00589147 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 397 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which The Zimmer NexGen Legacy Knee System, modular cemented tibia is the first listed.
NCT00589147 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00589147 about?
NCT00589147 is a clinical study titled "A Prospective, Randomized, Controlled Study Comparing Three Tibial Component Designs in Total Knee Arthoplasty". SUMMARY A prospective, randomized, single-blinded clinical trial is proposed to compare three tibial tray designs for patients undergoing total knee arthroplasty. This study is designed to address the clinically important issues of tibial component modularity and fixation in total knee replacement. ...
What is the current status of trial NCT00589147?
This trial is currently completed. It is a NA study. The enrollment target is 397 participants. The study started on 2003-08. Estimated completion is 2007-06.
What interventions are being tested in trial NCT00589147?
The interventions under investigation include: The Zimmer NexGen Legacy Knee System, modular cemented tibia (DEVICE), The Zimmer NexGen Legacy Knee System, non-modular cemented tibia. (DEVICE), The Zimmer NexGen Legacy Knee System, non-modular uncemented tibia (DEVICE).
Who is sponsoring clinical trial NCT00589147?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
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