Active — Not RecruitingNot Applicable

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

Denmark66 participantsStarted 2018-08-01

Plain-language 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.

Who can participate

Age range40 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Migration

Timeframe: 2 years

Trial details

NCT IDNCT03563131

SponsorRigshospitalet, Denmark

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-10-10

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