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The Importance of Different Implant Surfaces of the Tibial Component for Migration and Adaptive Bone Remodeling in Uncemented Total Knee Arthroplasty (Vanguard Versus Regenerex)

NCT01936415 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2013-09-06

No results posted yet for this study

Summary

In a prospective randomised study two uncemented tibial components with different coating (Vanguard® porous coating, Biomet and Regenerex® Primary Tibial Tray, Trabecular Metal coating, Biomet) used for total knee arthroplasty (TKA) are evaluated. Both tibial component coatings are designed to provide excellent conditions for bone ingrowth.

The differences between the two tibial components are evaluated by measurements of migration of the tibial component assessed by Radiostereometric analysis (RSA) and measurements of the adaptive bone remodeling of the proximal tibial assessed by dual energy X-ray absorptiometry (DEXA).

Conditions

  • Artrosis of the Knee

Interventions

DEVICE

Vanguard

A prospective randomized study where the patients are randomized to receive one of two prostheses (tibial components) with different coating: Vanguard pourous coating, Biomet and Regenerex® Primary Tibial Tray, Biomet. Both prostheses are available and approved by the FDA. The main difference between the implants is the coating of the tibial tray

DEVICE

Regenerex

Sponsors & Collaborators

  • Zimmer Biomet

    collaborator INDUSTRY

  • Hillerod Hospital, Denmark

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01936415 on ClinicalTrials.gov