NCT00894361

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

A Randomized Prospective Comparison of Mobile-Bearing and Fixed-Bearing (All-Polyethylene Tibia) Cruciate-Substituting Total Knee Arthroplasty (TKA) Designs

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Minneapolis Veterans Affairs Medical Center · Federal
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
PROCEDURE	TKA surgery with the rotating platform mobile-bearing knee design	Depuy Sigma RP rotating platform design
PROCEDURE	TKA surgery with the all-polyethylene tibia knee design	Depuy Sigma fixed-bearing design with all-polyethylene tibia

Timeline

• Start date: 2001-10-01
• Primary completion: 2007-01-01
• Completion: 2007-01-01
• First posted: 2009-05-07
• Last updated: 2020-09-07
• Results posted: 2009-05-07

Locations

1 site across 1 country: United States