Tibial and Femoral Components Migration and Adaptive Bone Remodeling After Insertion of Persona® TKA (NCT03563131) | Clinical Trial Compass
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 range
40 Years – 70 Years
Sex
ALL
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.