Clinical trial NCT05571449: Efficacy of the Use of 3D Printing Models in the Treatment of Tibial Plateau Fractures: a Randomized Clinical Trial
Official title: Efficacy of the Use of 3D Printing Models in the Treatment of Tibial Plateau Fractures: a Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tibial Plateau Fracture
Keywords: 3D printing
Tibial fracture
Lead sponsor: Puerta de Hierro University Hospital
Sponsor class: OTHER
First posted: 2022-10-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Surgical time
timeFrame: Week 1
measure: Fluoroscopy time.
timeFrame: Week 1
Secondary outcomes:
measure: Ease of surgical planning with 3d printing
timeFrame: Week 1
measure: Complications
timeFrame: Week 1 - 12 months
Other outcomes:
measure: Visual Analogis Scale for Pain
timeFrame: 6 weeks - 12 months
measure: KOOS Questionarie
timeFrame: 6 weeks - 12 months
measure: EuroQol-5D Questionarie
timeFrame: 6 weeks - 12 months
measure: WOMAC Questionarie
timeFrame: 6 weeks - 12 months
Locations:
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
state: Madrid
Study officials:
affiliation: Hospital Universitario Puerta de Hierro
name: Pedro J Torrijos Garrido, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: