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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Tibial Plateau Fracture

Intervention / Treatment
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* Procedure: Open reduction and internal fixation
* Procedure: Standard osteosynthesis planning
* Procedure: 3-D model osteosynthesis planning


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Planning of tibial plateau fracture osteosynthesis by using a three-dimensional model of the fracture. | Procedure: Open reduction and internal fixation<br>* Internal fixation of the fracture<br>Procedure: Standard osteosynthesis planning<br>* Plain radiograph and CT images are used<br>Procedure: 3-D model osteosynthesis planning<br>* A 3D plastic model made from CT images is used<br>|
| Other: Control group<br>Standard planning of tibial plateau fracture osteosynthesis (by plain radiography and computed tomography imaging). | Procedure: Open reduction and internal fixation<br>* Internal fixation of the fracture<br>Procedure: Standard osteosynthesis planning<br>* Plain radiograph and CT images are used<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical time | Surgical time will include the time from skin incision to wound closure | Week 1 | 
| Fluoroscopy time. | Intraoperative fluoroscopy time will be counted after incision and before wound closure. | Week 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | Week 1 - 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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3D printing, Tibial fracture