Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT03563131
NA

Tibial and Femoral Components Migration and Adaptive Bone Remodeling After Insertion of Persona® TKA

Sponsor: Rigshospitalet, Denmark

View on ClinicalTrials.gov

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

Interventions

DEVICE

Persona® total knee arthroplasty

Insertion of the cemented or uncemented Persona® total knee arthroplasty

Locations (1)

Gentofte Hospital

Hellerup, Denmark