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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 31, 2014