NCT05571449

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Pedro-José Torrijos-Garrido · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Tibial Plateau Fracture

Interventions

Type	Name	Description
PROCEDURE	Open reduction and internal fixation	Internal fixation of the fracture
PROCEDURE	Standard osteosynthesis planning	Plain radiograph and CT images are used
PROCEDURE	3-D model osteosynthesis planning	A 3D plastic model made from CT images is used

Timeline

• Start date: 2022-10-01
• Primary completion: 2024-10-01
• Completion: 2025-10-01
• First posted: 2022-10-07
• Last updated: 2024-02-29

Locations

1 site across 1 country: Spain