Plasmafit® Revision Structan® Hip Endoprosthesis Cup (NCT04255966) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Plasmafit® Revision Structan® Hip Endoprosthesis Cup
Germany60 participantsStarted 2021-04-12
Plain-language summary
The aim of this observational study is to collect clinical and radiological results of the new Plasmafit® Revision Structan® Hip Endoprosthesis Cup in a standard patient population and when used in routine clinical practice.
Who can participate
Age range
18 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
* Indication for the cementless Plasmafit® Revision Structan® Hip Endoprosthesis Cup (primary and revision cases, with bone conditions typically demanding a press-fit revision cup)
* Written informed consent
* Cases where a press-fit cup fixation is possible
Exclusion Criteria
* Patients \< 18 years
* Pregnant patients
* Patients not able to comply with the study demands, i.e. follow-up visits (mentally or physically)
* Patient has an infection in the hip joint region
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.
1This trial is studying a revision hip implant called the Plasmafit® Revision Structan® cup and is tracking how well people's hips function over time using something called the Harris Hip Score — can you explain what that score measures and whether my current hip function would be a useful baseline to compare against?
2Since this trial is listed as 'active not recruiting,' meaning they're no longer enrolling new patients, does that affect whether any of the findings or the implant itself might be relevant to the revision hip surgery options you'd recommend for me?
3This study covers a wide range of reasons someone might need revision hip surgery, including prosthesis failure, joint instability, and bone loss called osteolysis — which of those most closely matches my situation, and does that affect which revision implant or approach makes the most sense for me?
4This trial has no assigned phase, which often means it's primarily tracking real-world outcomes rather than testing something brand new in a controlled way — does that change how much confidence you'd have in the safety and performance data it eventually produces?
5Are there standard revision hip replacement options already in established clinical use that you'd want me to consider before or alongside anything connected to this type of implant study?
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.
What they're measuring
1
Harris Hip Score (Functional results of the operated hip) over time