Comparison of a Metal Backed Fixed-Bearing Tibial Baseplate and an All-Polyethylene Tibia in Total Knee Arthroplasty
Stopped early · Not applicable
Conditions studied: Osteoarthritis, Knee
In brief
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.
Key facts
- Study ID
- NCT00979147
- Run by
- Minneapolis Veterans Affairs Medical Center
- People needed
- 400
- Starts
- 2007-11-01
- Expected to finish
- 2013-11-01
- Last updated by the study team
- 2020-09-07
Who can join
Age: 60 and older, up to 85. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- generally accepted clinical and radiographic criteria for total knee arthroplasty
You may not qualify if…
- Significant angular or bony deformity necessitating structural bone grafting or more extensive modular designs will be excluded at the discretion of the principle investigator
- Routine contraindications to TKA (active sepsis, Charcot arthropathy)
- Patients whose mental function preclude them from responding to our standard questionnaires
Where it is running
- Minneapolis VAMC — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.