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

Tibial Plateau Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05571449
• Other study ID #: TIBIA3D
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: October 1, 2025

Study information

• Verified date: February 2024
• Source: Puerta de Hierro University Hospital
• Contact: Pedro J Torrijos Garrido, MD, PhD
• Phone: +34 91 191 74 85
• Email: pedrojose.torrijos[@]salud.madrid.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 1, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Tibial Plateau Fracture

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Spain	Hospital Universitario Puerta de Hierro Majadahonda	Majadahonda	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Pedro-José Torrijos-Garrido

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Visual Analogis Scale for Pain	VAS measure the intensity of the pain that the patient describes. It consists of a horizontal line of 10 centimeters, with 0cm being "no pain" and 10cm being "extreme pain".	6 weeks - 12 months
Other	KOOS Questionarie	The Knee injury and Osteoarthritis Outcome Score (KOOS) has been developed as an instrument to assess the patient's opinion about their knee and associated problems It has to separate sections ("Knee Score" and "Functional Score") that are scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.	6 weeks - 12 months
Other	EuroQol-5D Questionarie	Generic instrument for measuring health-related quality of life, in which the individual himself assesses his health status (0-100 score)	6 weeks - 12 months
Other	WOMAC Questionarie	It is the most widely used questionnaire to assess the results after knee and hip arthroplasty in patients with osteoarthritis in the lower extremity (0-68 score)	6 weeks - 12 months
Primary	Surgical time	Surgical time will include the time from skin incision to wound closure	Week 1
Primary	Fluoroscopy time.	Intraoperative fluoroscopy time will be counted after incision and before wound closure.	Week 1
Secondary	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
Secondary	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