NCT00979147

Brief Summary

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. 1.Does a MPT/XLK design have improved wear characteristics over a nonmodular APT/GVF design?
  2. 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?

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 17, 2009

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
6.9 years until next milestone

Results Posted

Study results publicly available

September 7, 2020

Completed
Last Updated

September 7, 2020

Status Verified

September 1, 2020

Enrollment Period

5.5 years

First QC Date

September 16, 2009

Results QC Date

September 3, 2020

Last Update Submit

September 3, 2020

Conditions

Osteoarthritis, Knee

Keywords

knee arthritistotal knee arthroplastytotal knee replacementmetal backed tibial componentall-polyethylene tibiamodular polished tibial baseplate

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Wear Characteristics of the Standard GVF Polyethylene vs. the Moderately Cross-linked XLK Polyethylene

    2 year followup intervals to 20 years

Study Arms (2)

Modular Metal Tibial Baseplate

EXPERIMENTAL

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

Procedure: TKA surgery with modular polished tibial baseplate/XLK designDevice: P.F.C.® Sigma Knee System

All Polyethylene Tibial Baseplate

ACTIVE COMPARATOR

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

Procedure: TKA surgery with the nonmodular APT/GVF designDevice: P.F.C.® Sigma Knee System

Interventions

TKA surgery with modular polished tibial baseplate/XLK designPROCEDURE

TKA surgery with modular polished tibial baseplate/XLK design

Also known as: P.F.C.® Sigma Knee System with modular XLK poly
Modular Metal Tibial Baseplate
TKA surgery with the nonmodular APT/GVF designPROCEDURE

TKA surgery with the nonmodular APT/GVF design

Also known as: P.F.C. ® Sigma Knee with an all-poly GVF tibia
All Polyethylene Tibial Baseplate
P.F.C.® Sigma Knee SystemDEVICE

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

Modular Metal Tibial Baseplate

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • generally accepted clinical and radiographic criteria for total knee arthroplasty

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minneapolis VAMC

Minneapolis, Minnesota, 55417, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Limitations and Caveats

PI/study coordinator retired due to personal family health matters; study sponsor withdrew funding. Study terminated and no data collected or analyzed

Results Point of Contact

Title
Terence Gioe M.D.
Organization
Minneapolis VAMC
tjgioe@gmail.com
612-467-1780

Study Officials

  • Terence J Gioe, M.D.

    Minneapolis VAMC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Orthopaedic Surgery

Study Record Dates

First Submitted

September 16, 2009

First Posted

September 17, 2009

Study Start

November 1, 2007

Primary Completion

May 1, 2013

Study Completion

November 1, 2013

Last Updated

September 7, 2020

Results First Posted

September 7, 2020

Record last verified: 2020-09

Locations

US(1)