The Importance of Different Implant Surfaces of the Tibial Component for Migration and Adaptive B… (NCT01936415) | Clinical Trial Compass
CompletedPhase 4
The Importance of Different Implant Surfaces of the Tibial Component for Migration and Adaptive Bone Remodeling in Uncemented Total Knee Arthroplasty (Vanguard Versus Regenerex)
Denmark60 participantsStarted 2010-05
Plain-language summary
In a prospective randomised study two uncemented tibial components with different coating (Vanguard® porous coating, Biomet and Regenerex® Primary Tibial Tray, Trabecular Metal coating, Biomet) used for total knee arthroplasty (TKA) are evaluated. Both tibial component coatings are designed to provide excellent conditions for bone ingrowth.
The differences between the two tibial components are evaluated by measurements of migration of the tibial component assessed by Radiostereometric analysis (RSA) and measurements of the adaptive bone remodeling of the proximal tibial assessed by dual energy X-ray absorptiometry (DEXA).
Who can participate
Age range
18 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
. Severe osteoarthrosis of the knee with indication for a TKA.
. Age between 18 and 70 years.
Exclusion criteria
. Diseases affecting the bone metabolism (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.
. Premenopausal women.
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.