Comparison of a Metal Backed Fixed-Bearing Tibial Baseplate and an All-Polyethylene Tibia in Total Knee Arthroplasty

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2013-11-30

Brief Summary

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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.

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Detailed Description

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Summary is detailed

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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Modular Metal Tibial Baseplate

Patients who were randomized to receive the modular polished tibial baseplate/XLK TKA

Group Type EXPERIMENTAL

TKA surgery with modular polished tibial baseplate/XLK design

Intervention Type PROCEDURE

TKA surgery with modular polished tibial baseplate/XLK design

P.F.C.® Sigma Knee System

Intervention Type DEVICE

P.F.C.® Sigma Knee System with modular XLK poly

All Polyethylene Tibial Baseplate

Patients who were randomized to receive the nonmodular APT/GVF TKA design.

Group Type ACTIVE_COMPARATOR

TKA surgery with the nonmodular APT/GVF design

Intervention Type PROCEDURE

TKA surgery with the nonmodular APT/GVF design

P.F.C.® Sigma Knee System

Intervention Type DEVICE

P.F.C. ® Sigma Knee System with an all-poly GVF tibia

Interventions

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TKA surgery with modular polished tibial baseplate/XLK design

Intervention Type PROCEDURE

TKA surgery with the nonmodular APT/GVF design

Intervention Type PROCEDURE

P.F.C.® Sigma Knee System

P.F.C.® Sigma Knee System with modular XLK poly

Intervention Type DEVICE

P.F.C.® Sigma Knee System

P.F.C. ® Sigma Knee System with an all-poly GVF tibia

Intervention Type DEVICE

Other Intervention Names

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P.F.C.® Sigma Knee System with modular XLK poly P.F.C. ® Sigma Knee with an all-poly GVF tibia

Eligibility Criteria

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Inclusion Criteria

* generally accepted clinical and radiographic criteria for total knee arthroplasty

Exclusion Criteria

* 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

Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes