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

Study Overview
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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: Does a MPT/XLK design have improved wear characteristics over a nonmodular APT/GVF design? 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.

Detailed Description
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Summary is detailed

Official Title
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A Randomized Prospective Level 1 Comparison of a Modular Polished Fixed-Bearing Tibial Baseplate and an All-Polyethylene Tibia in Total Knee Arthroplasty

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Procedure: TKA surgery with modular polished tibial baseplate/XLK design
* Procedure: TKA surgery with the nonmodular APT/GVF design
* Device: P.F.C.® Sigma Knee System
* Device: P.F.C.® Sigma Knee System


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modular Metal Tibial Baseplate<br>Patients who were randomized to receive the modular polished tibial baseplate/XLK TKA | Procedure: TKA surgery with modular polished tibial baseplate/XLK design<br>* TKA surgery with modular polished tibial baseplate/XLK design<br>* Other names: P.F.C.® Sigma Knee System with modular XLK poly;Device: P.F.C.® Sigma Knee System<br>* P.F.C.® Sigma Knee System with modular XLK poly<br>|
| Active Comparator: All Polyethylene Tibial Baseplate<br>Patients who were randomized to receive the nonmodular APT/GVF TKA design. | Procedure: TKA surgery with the nonmodular APT/GVF design<br>* TKA surgery with the nonmodular APT/GVF design<br>* Other names: P.F.C. ® Sigma Knee with an all-poly GVF tibia;Device: P.F.C.® Sigma Knee System<br>* P.F.C. ® Sigma Knee System with an all-poly GVF tibia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical and Functional Outcomes Based on Standardized Validated TKA Outcome Instruments (KSS, KOOS, WOMAC, SF-36) | Patient recorded outcome measures as noted | 2 year follow-up intervals up to 20 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wear Characteristics of the Standard GVF Polyethylene vs. the Moderately Cross-linked XLK Polyethylene | Wear characteristics as above | 2 year followup intervals to 20 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee arthritis, total knee arthroplasty, total knee replacement, metal backed tibial component, all-polyethylene tibia, modular polished tibial baseplate