Efficacy of the Use of 3D Printing Models in the Treatment of Tibial Plateau Fractures: a Randomized Clinical Trial
NCT ID: NCT05571449
Last Updated: 2024-02-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2022-10-01
2025-10-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental group
Planning of tibial plateau fracture osteosynthesis by using a three-dimensional model of the fracture.
Open reduction and internal fixation
Internal fixation of the fracture
Standard osteosynthesis planning
Plain radiograph and CT images are used
3-D model osteosynthesis planning
A 3D plastic model made from CT images is used
Control group
Standard planning of tibial plateau fracture osteosynthesis (by plain radiography and computed tomography imaging).
Open reduction and internal fixation
Internal fixation of the fracture
Standard osteosynthesis planning
Plain radiograph and CT images are used
Interventions
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Open reduction and internal fixation
Internal fixation of the fracture
Standard osteosynthesis planning
Plain radiograph and CT images are used
3-D model osteosynthesis planning
A 3D plastic model made from CT images is used
Eligibility Criteria
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Inclusion Criteria
* Age equal to or greater than 18 years.
* Signature of informed consent in writing according to current legislation before collecting any information.
Exclusion Criteria
* 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.
18 Years
99 Years
ALL
No
Sponsors
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Pedro-José Torrijos-Garrido
OTHER
Responsible Party
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Pedro-José Torrijos-Garrido
Principal Investigator
Principal Investigators
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Pedro J Torrijos Garrido, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Puerta de Hierro
Locations
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Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TIBIA3D
Identifier Type: -
Identifier Source: org_study_id
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