Comparison of Mobile-Bearing and Fixed-Bearing All-Polyethylene Tibia Total Knee Designs

Stopped early · Phase 4

Conditions studied: Osteoarthritis, Knee

In brief

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.

Key facts

Study ID: NCT00894361
Run by: Minneapolis Veterans Affairs Medical Center
People needed: 400
Starts: 2001-10-01
Expected to finish: 2007-01-01
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 primary total knee arthroplasty

You may not qualify if…

substantial angular deformity or bony deformity requiring structural grafting or modular augmentation were excluded at the discretion of the principle investigator
patients whose mental function precluded them from responding to our standard questionnaires

Where it is running

Minneapolis VAMC — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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