Efficacy of the Use of 3D Printing Models in the Treatment of Tibial Plateau Fractures: a Randomized Clinical Trial

Tibial Plateau Fracture Clinical Trial

Official title: Efficacy of the Use of 3D Printing Models in the Treatment of Tibial Plateau Fractures: a Prospective Randomized Clinical Trial

Status Recruiting

Clinical Trial 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

Clinical Trial Description

Randomized, open and prospective study.

Once the surgical indication for osteosynthesis has been established after having suffered a tibial plateau fracture, the patients will be randomized in a 1:1 ratio to one of the tfollowing treatment groups:

Control group: images obtained by plain radiography and computed tomography are used in the planning of osteosynthesis of the tibial plateau fracture.

Experimental group: in the planning of tibial plateau fracture osteosynthesis, in addition to images obtained by plain radiography and computed tomography, a three-dimensional plastic model printed by processing the tomography images is used.

Patients (or their legal representatives) must sign the consent before randomization.

After surgery, a follow-up will be carried out at 3, 6 and 12 months, visits in which data will be collected regarding the physical examination, radiological examination, pain and questionnaires will be filled out regarding the functionality of the knee and perception of health status. ;

Related Conditions & MeSH terms

• Fractures, Bone
• Tibial Plateau Fracture

• NCT number: NCT05571449
• Study type: Interventional
• Source: Puerta de Hierro University Hospital
• Contact: Pedro J Torrijos Garrido, MD, PhD
• Phone: +34 91 191 74 85
• Email: pedrojose.torrijos@salud.madrid.org
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Completion date: October 1, 2025