The Importance of Different Modularity of the Polyethylene Insert for Tibial Component Migration and Adaptive Bone Remodeling After Uncemented Total Knee Arthroplasty Using Trabecular Metal Technology (TMT) Zimmer NexGen®, (Monoblock vs. Modular Design)

NAActive, not recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

July 31, 2012

Primary Completion Date

May 31, 2015

Study Completion Date

August 31, 2026

Conditions
Arthrosis of the Knee
Interventions
DEVICE

Zimmer NexGen® Trabecular Metal Technology (TMT), Monoblock

"A prospective randomized study where the patients are randomized too receive a monoblock tibial component with trabecular metal coating (TMT Zimmer NexGen®) or a modular tibial component (TMT Zimmer NexGen®). Both prostheses are available and approved by the FDA and CE. The only difference between the implants is that of the polyethylene insert (monoblock vs. modular).~The operations are performed at the Department of Planned Elective Surgery Z, Gentofte Hospital by two experienced TKA surgeons that will be included in the research group. During surgery a minimum of 4 Tantalum markers (0.8 mm) is inserted in the bone of the proximal tibia and 6 markers are inserted in the polyethylene insert."

DEVICE

Zimmer NexGen® Trabecular Metal Technology (TMT), Modular

"A prospective randomized study where the patients are randomized too receive a monoblock tibial component with trabecular metal coating (TMT Zimmer NexGen®) or a modular tibial component (TMT Zimmer NexGen®). Both prostheses are available and approved by the FDA and CE. The only difference between the implants is that of the polyethylene insert (monoblock vs. modular).~The operations are performed at the Department of Planned Elective Surgery Z, Gentofte Hospital by two experienced TKA surgeons that will be included in the research group. During surgery a minimum of 4 Tantalum markers (0.8 mm) is inserted in the bone of the proximal tibia and 6 markers are inserted in the polyethylene insert."

Trial Locations (2)

2900

Gentofte Hospital, Copenhagen

Gentofte Hospital, Copenhagen

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Zimmer Biomet

INDUSTRY

lead

Rigshospitalet, Denmark

OTHER