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

This study has been completed.
Sponsor:
Collaborator:
Depuy, Inc.
Information provided by (Responsible Party):
Terence J. Gioe, M.D., Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT00979147
First received: September 16, 2009
Last updated: June 24, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Osteoarthritis, Knee
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
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized Prospective Level 1 Comparison of a Modular Polished Fixed-Bearing Tibial Baseplate and an All-Polyethylene Tibia in Total Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by Minneapolis Veterans Affairs Medical Center:

Primary Outcome Measures:
  • Clinical and functional outcomes based on standardized validated TKA outcome instruments (KSS, KOOS, WOMAC, SF-36) [ Time Frame: 2 year follow-up intervals up to 20 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Wear characteristics of the standard GVF polyethylene vs. the moderately cross-linked XLK polyethylene [ Time Frame: 2 year followup intervals to 20 years ] [ Designated as safety issue: No ]

Enrollment: 400
Study Start Date: November 2007
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Modular Metal Tibial Baseplate
Patients who were randomized to receive the modular polished tibial baseplate/XLK TKA
Procedure: TKA surgery with modular polished tibial baseplate/XLK design
TKA surgery with modular polished tibial baseplate/XLK design
Other Name: P.F.C.® Sigma Knee System with modular XLK poly
Device: P.F.C.® Sigma Knee System
P.F.C.® Sigma Knee System with modular XLK poly
Active Comparator: All Polyethylene Tibial Baseplate
Patients who were randomized to receive the nonmodular APT/GVF TKA design.
Procedure: TKA surgery with the nonmodular APT/GVF design
TKA surgery with the nonmodular APT/GVF design
Other Name: P.F.C. ® Sigma Knee with an all-poly GVF tibia
Device: P.F.C.® Sigma Knee System
P.F.C. ® Sigma Knee System with an all-poly GVF tibia

  Eligibility

Ages Eligible for Study:   60 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00979147

Locations
United States, Minnesota
Minneapolis VAMC
Minneapolis, Minnesota, United States, 55417
Sponsors and Collaborators
Minneapolis Veterans Affairs Medical Center
Depuy, Inc.
Investigators
Principal Investigator: Terence J Gioe, M.D. Minneapolis VAMC
  More Information

No publications provided

Responsible Party: Terence J. Gioe, M.D., Chief of Orthopaedic Surgery, Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT00979147     History of Changes
Other Study ID Numbers: MVA-3946B
Study First Received: September 16, 2009
Last Updated: June 24, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Minneapolis Veterans Affairs Medical Center:
knee arthritis
total knee arthroplasty
total knee replacement
metal backed tibial component
all-polyethylene tibia
modular polished tibial baseplate

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 16, 2014