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Clinical Trials in Denmark / NCT03563131
Active, not recruiting Not applicable

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

NCT03563131 · tracked via the Priya Life Science Denmark tracker
Sponsor
Copenhagen University Hospital, Rigshospitalet
Phase
Not applicable
Started
2018-08-01
Last updated
2024-06-25

Condition(s) studied

Osteo Arthritis Knee

Investigational drug(s) / intervention(s)

Persona® total knee arthroplasty

Persona® total knee arthroplasty: Insertion of the cemented or uncemented Persona® total knee arthroplasty

Study 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.

Eligibility

Sex
ALL
Min age
40 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * Osteoarthrosis of the knee with indication for a TKA. * Age between 40 and 70 years. Exclusion Criteria: * If a standard cruciate retaining implants cannot be used due to e.g. severe malalignment/deformity or instability. * Diseases affecting the bone metabolism (severe 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.

Primary outcome measure(s)

  • Migration — 2 years
    The differences between the cemented and uncemented implants are evaluated by measurements of migration of the stem assesed by Radiosteriometric analysis (RSA), measuring the migration by the MB-RSA Commercial software.

Trial sites (1)

FacilityCityRegionStatus
Gentofte Hospital Hellerup Denmark

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03563131 on ClinicalTrials.gov ↗ ← All trials in Denmark