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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-10-31

Study Completion Date

2007-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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rotating-platform design TKA

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

Group Type ACTIVE_COMPARATOR

TKA surgery with the rotating platform mobile-bearing knee design

Intervention Type PROCEDURE

Depuy Sigma RP rotating platform design

all-polyethylene tibia design TKA

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

Group Type ACTIVE_COMPARATOR

TKA surgery with the all-polyethylene tibia knee design

Intervention Type PROCEDURE

Depuy Sigma fixed-bearing design with all-polyethylene tibia

Interventions

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TKA surgery with the rotating platform mobile-bearing knee design

Depuy Sigma RP rotating platform design

Intervention Type PROCEDURE

TKA surgery with the all-polyethylene tibia knee design

Depuy Sigma fixed-bearing design with all-polyethylene tibia

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes