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

Sponsor:	Minneapolis Veterans Affairs Medical Center (VAMC)
Collaborator:	Depuy, Inc.
Information provided by:	Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:	NCT00979147

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:

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.

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:

MedlinePlus related topics: Knee Replacement Osteoarthritis

U.S. FDA Resources

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 ]

Estimated Enrollment:	400
Study Start Date:	November 2007

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

Contacts

Contact: Terence J Gioe, M.D.

612-467-1780

Terence.Gioe@va.gov

Locations

United States, Minnesota
Minneapolis VAMC	Recruiting
Minneapolis, Minnesota, United States, 55417

Sponsors and Collaborators

Minneapolis Veterans Affairs Medical Center (VAMC)

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, Dept. of Orthopaedic Surgery, Minneapolis VAMC, Minneapolis VAMC
ClinicalTrials.gov Identifier:	NCT00979147 History of Changes
Other Study ID Numbers:	MVA-3946B
Study First Received:	September 16, 2009
Last Updated:	July 20, 2011
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 May 23, 2012