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

Minneapolis Veterans Affairs Health Care System (VAHCS)

Status and phase: Terminated; Phase 4

Conditions: Osteoarthritis, Knee

Treatments: Procedure: TKA surgery with the rotating platform mobile-bearing knee design; Procedure: TKA surgery with the all-polyethylene tibia knee design

Study type: Interventional

Funder types: Other U.S. Federal agency; Industry

Identifiers

NCT00894361

MVA-3028

Details and patient eligibility

About

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.

Enrollment: 400 patients

Sex: All

Ages: 60 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• generally accepted clinical and radiographic criteria for primary total knee arthroplasty

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

rotating-platform design TKA

Active Comparator group

Description:

patients who were randomized to receive the rotating platform mobile-bearing TKA design

Treatment:

Procedure: TKA surgery with the rotating platform mobile-bearing knee design

all-polyethylene tibia design TKA

Active Comparator group

Description:

patients who were randomized to receive the all-polyethylene tibial component design

Treatment:

Procedure: TKA surgery with the all-polyethylene tibia knee design