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

Pedro-José Torrijos-Garrido30 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Tibial Plateau Fracture

Interventions

Open reduction and internal fixationPROCEDURE

Internal fixation of the fracture

Standard osteosynthesis planningPROCEDURE

Plain radiograph and CT images are used

3-D model osteosynthesis planningPROCEDURE

A 3D plastic model made from CT images is used

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, Spain

RECRUITING

Outcomes

Primary Outcomes

Surgical time

Surgical time will include the time from skin incision to wound closure

Time frame: Week 1

Fluoroscopy time.

Intraoperative fluoroscopy time will be counted after incision and before wound closure.

Time frame: Week 1

Secondary Outcomes

Ease of surgical planning with 3d printing

Form filled out by the surgeon before the intervention to find out if the three-dimensional impression of the fracture has changed from the original preoperative planning that it had previously

Time frame: Week 1

Complications

The incidence of complications, such as superficial wound infection, deep wound infection, iatrogenic neurological symptoms, reduction loss and fixation failure, will be recorded in both groups.

Time frame: Week 1 - 12 months

Central Contacts

Pedro J Torrijos Garrido, MD, PhD

CONTACT

+34 91 191 74 85 pedrojose.torrijos@salud.madrid.org

Data from ClinicalTrials.gov

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