CERAMENTTM|G and V in the Management of Hip and Knee Arthroplasty Revisions (Revision Arthroplast… (NCT03389646) | Clinical Trial Compass
UnknownPhase 4
CERAMENTTM|G and V in the Management of Hip and Knee Arthroplasty Revisions (Revision Arthroplasty Italy)
Italy135 participantsStarted 2017-09-27
Plain-language summary
Open-label, multicentre, prospective cohort, observational clinical trial with a retrospective control group to evaluate the effectiveness and safety of CERAMENTTM\| G or V used for filling of bone defects in the tibia and / or femur shaft and/or acetabulum in patients scheduled for two-stage hip or knee prosthesis re-implantation for PJI or aseptic loosening.
The results will be compared to a cohort of patients, which have been treated before the introduction of CERAMENTTM\|G or V for the same indication.
Due to the observational character of the study, there will be no patient randomization and the clinicians in the study will remain entirely free to decide on the treatment of the patients according to established clinical practice.
Only patients for whom therapeutic strategy for the use of the product for filling bone defects is already planned according to local clinical practice, at the time of informed consent form signature, will be enrolled in this study. Thus, the decision for the choice of the surgical treatment, will not be influenced by the inclusion of the patient in this study.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
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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
. Written informed consent obtained prior to any study related procedure.
. Male or female age ≥ 18 and ≤ 85 years.
. Patients diagnosed with aseptic prosthetic loosening and scheduled for a one-stage hip or knee cementless or hybrid revision prosthesis implantation
. Patients with an interval spacer and scheduled for hip or knee cementless or hybrid revision prosthesis implantation.
. For those patients with an interval spacer, previous infection caused by microorganism(s) sensitive to gentamicin or vancomycin.
. Able (in the Investigators opinion) and willing to comply with all study requirements
Exclusion criteria
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.
. Soft-tissue defects that prevent direct skin closure at revision surgery.
. Females who are pregnant or lactating.
. Females of child bearing potential and not taking adequate contraceptive precautions are excluded from the trial. Females of child bearing potential taking acceptable contraceptive precautions may be included.
. Known allergy to gentamicin or vancomycin (or related antibiotics).
. Patients with previous nephro- or ototoxicity events due to aminoglycoside and/or vancomycin (or glycopeptides) use.
. Presence of relevant contraindications as described in the EU CE mark Instructions for Use (IFU).