Using 3D printed models to improve treatment of tibial plateau fractures
Efficacy of the Use of 3D Printing Models in the Treatment of Tibial Plateau Fractures: a Prospective Randomized Clinical Trial
NA · Puerta de Hierro University Hospital · NCT05571449
This study is testing if using 3D printed models for surgery can help people with tibial plateau fractures recover better and feel less pain compared to standard methods.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Puerta de Hierro University Hospital (other) |
| Locations | 1 site (Majadahonda, Madrid) |
| Trial ID | NCT05571449 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of using 3D printed models in the surgical treatment of tibial plateau fractures. Patients will be randomly assigned to either a control group, which uses standard imaging techniques for surgical planning, or an experimental group that incorporates a 3D printed model based on their imaging data. The study aims to assess outcomes such as pain, knee functionality, and overall health perception through follow-up visits at 3, 6, and 12 months post-surgery. Informed consent will be obtained from all participants prior to randomization.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with tibial plateau fractures requiring surgical intervention.
Not a fit: Patients with serious systemic conditions, other significant fractures, or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and recovery for patients with tibial plateau fractures.
How similar studies have performed: While the use of 3D printing in surgical planning is gaining traction, this specific application in tibial plateau fractures is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Majadahonda, Madrid
- Hospital Universitario Puerta de Hierro Majadahonda — Majadahonda, Madrid, Spain (RECRUITING)
Study contacts
- Principal investigator: Pedro J Torrijos Garrido, MD, PhD — Hospital Universitario Puerta de Hierro
- Study coordinator: Pedro J Torrijos Garrido, MD, PhD
- Email: pedrojose.torrijos@salud.madrid.org
- Phone: +34 91 191 74 85
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Tibial Plateau Fracture, 3D printing, Tibial fracture