CompletedPhase 4

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

Denmark60 participantsStarted 2010-05

Plain-language 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).

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. Severe osteoarthrosis of the knee with indication for a TKA.
✓. Age between 18 and 70 years.

Exclusion criteria

✕. Diseases affecting the bone metabolism (osteoporosis, Pagets disease, hyperparathyreoidism etc.).
✕. Patients estimated not to be able to understand the "Information to patients" papers or do not want to participate in the study.
✕. Premenopausal women.

What they're measuring

Migration of the tibial component

Timeframe: three years

Trial details

NCT IDNCT01936415

SponsorHillerod Hospital, Denmark

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-08

View on ClinicalTrials.gov More Artrosis of the Knee trials