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

Pedro-José Torrijos-Garrido

Status: Enrolling

Conditions: Tibial Plateau Fracture

Treatments: Procedure: Open reduction and internal fixation; Procedure: 3-D model osteosynthesis planning; Procedure: Standard osteosynthesis planning

Study type: Interventional

Funder types: Other

Identifiers

NCT05571449

TIBIA3D

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Experimental group

Experimental group

Description:

Planning of tibial plateau fracture osteosynthesis by using a three-dimensional model of the fracture.

Treatment:

Procedure: Standard osteosynthesis planning

Procedure: 3-D model osteosynthesis planning

Procedure: Open reduction and internal fixation

Control group

Other group

Description:

Standard planning of tibial plateau fracture osteosynthesis (by plain radiography and computed tomography imaging).

Treatment:

Procedure: Standard osteosynthesis planning

Procedure: Open reduction and internal fixation