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

NCT03563131 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2024-06-25

No results posted yet for this 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.

Conditions

  • Osteo Arthritis Knee

Interventions

DEVICE

Persona® total knee arthroplasty

Insertion of the cemented or uncemented Persona® total knee arthroplasty

Sponsors & Collaborators

  • Gentofte Hospital, Denmark

    collaborator UNKNOWN

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Michael M Petersen, Professor · Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2019-10-10
Completion
2026-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03563131 on ClinicalTrials.gov