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Tibial and Femoral Components Migration and Adaptive Bone Remodeling After Insertion of Persona® TKA
Sponsor: Rigshospitalet, Denmark
Summary
The purpose of this study: In a prospective randomized study with 2 years of follow-up we want to compare the migration of the uncemented trabecular metal (TM) versus the cemented tibial and femoral components of the new Persona® total knee arthroplasty (TKA) assessed by model based radiostereometric analysis (MB-RSA). Also, we want to compare the adaptive bone remodeling induced by the uncemented TM versus the cemented tibial and femoral components of the new Persona® TKA assessed by dual energy-X-ray (DEXA). Data generated for both above mentioned, will be also compared with historical RSA and DEXA data for the NexGen TKA using TM tibia modular and monoblock.
Official title: Tibial and Femoral Components Migration and Adaptive Bone Remodeling After Insertion of Persona® Total Knee Arthroplasty. A RCT Using RSA and DEXA Analysis for Evaluation of Uncemented With Trabecular Metal Surface vs. Cemented Fixation
Key Details
Gender
All
Age Range
40 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
66
Start Date
2018-08-01
Completion Date
2026-12-31
Last Updated
2024-06-25
Healthy Volunteers
No
Conditions
Interventions
Persona® total knee arthroplasty
Insertion of the cemented or uncemented Persona® total knee arthroplasty
Locations (1)
Gentofte Hospital
Hellerup, Denmark