Efficacy of the Use of 3D Printing Models in the Treatment of Tibial Plateau Fractures: a Randomi… (NCT05571449) | Clinical Trial Compass
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Efficacy of the Use of 3D Printing Models in the Treatment of Tibial Plateau Fractures: a Randomized Clinical Trial
Spain30 participantsStarted 2022-10-01
Plain-language summary
TIBIA3D is a randomized, open and prospective clinical trail that evaluates the use of preoperative 3D printing in the surgical treatment of patients with tibial plateau fractures
Who can participate
Age range
18 Years – 99 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:
* Patients with tibial plateau fracture requiring surgical treatment.
* Age equal to or greater than 18 years.
* Signature of informed consent in writing according to current legislation before collecting any information.
Exclusion Criteria:
* Pregnancy in progress.
* Presence of serious systemic pathology or another situation that contraindicates treatment
* Presence of other fractures in the ipsilateral femur or tibia that condition the surgical treatment of the tibial plateau fracture.
* Findings in the physical examination, in the results of the tests or other medical, social or psychopathological factors that, in the opinion of the investigators, could negatively influence the study.
* Inability to grant informed consent in the absence of a legal representative.
* Inability to follow instructions or collaborate during the development of 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.