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NCT00589108 · ClinicalTrials.gov registry record · NA
Comparison of A Mobile-Bearing Total Knee System With A Fixed-Bearing Total Knee System In Cemented Total Knee Arthroplasty
A NA study, sponsored by Mayo Clinic.
- Completed
- Registry status
- NA
- Development phase
- 240
- Enrollment target
NCT00589108: Completed NA study, sponsored by Mayo Clinic.
NCT00589108 is a NA study that has completed, run by Mayo Clinic. The registered enrollment target is 240 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00589108, a NA study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 240 participants
- Enrollment target
Study Summary
Pain, weakness, instability, and progressive dysfunction are the hallmarks of arthritis of the knee. Total knee replacement may frequently be the only therapeutic intervention to provide adequate improvement in pain and function. Both fixed bearing and mobile bearing knees have a long track record of clinical success. Mobile bearing designs have theoretical advantages of decreased contact stresses on the tibial tray, decreased polyethylene wear, and improved range of motion relative to fixed bearing designs. These theoretical advantages may become especially important in the young patient who requires a knee arthroplasty. This study will attempt to see if there is a clinical difference in outcome between mobile bearing and fixed bearing knee arthroplasties in patients who require total knee replacement.
Primary Outcome
The range of knee motion was measured clinically with use of a goniometer. Measurements were performed by physician assistants in the Department of Orthopedic Surgery who were blinded to the type of implant used. The subject was positioned supine on the examination table, and maximum active flexion was measured.
Interventions
- DEVICE Sigma Knee System
- DEVICE Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray
- DEVICE Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2001-01 |
| Est. Completion | 2011-05 |
| Phase | NA |
What the finished NCT00589108 record still lists
NCT00589108 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 3 interventions - of which Sigma Knee System is the first listed.
NCT00589108 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00589108 about?
NCT00589108 is a clinical study titled "Comparison of A Mobile-Bearing Total Knee System With A Fixed-Bearing Total Knee System In Cemented Total Knee Arthroplasty". Pain, weakness, instability, and progressive dysfunction are the hallmarks of arthritis of the knee. Total knee replacement may frequently be the only therapeutic intervention to provide adequate improvement in pain and function. Both fixed bearing and mobile bearing knees have a long track record o...
What is the current status of trial NCT00589108?
This trial is currently completed. It is a NA study. The enrollment target is 240 participants. The study started on 2001-01. Estimated completion is 2011-05.
What interventions are being tested in trial NCT00589108?
The interventions under investigation include: Sigma Knee System (DEVICE), Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray (DEVICE), Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray (DEVICE).
Who is sponsoring clinical trial NCT00589108?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00589108's enrollment target sits among peer trials
240 440th of 2000 higher than 1,542 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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