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

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

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

Study Overview

• Status: Recruiting
• Conditions: Tibial Plateau Fracture
• Intervention / Treatment: Procedure: Open reduction and internal fixation; Procedure: Standard osteosynthesis planning; Procedure: 3-D model osteosynthesis planning

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pedro J Torrijos Garrido, MD, PhD; Phone Number: +34 91 191 74 85; Email: pedrojose.torrijos@salud.madrid.org

Study Locations

• Spain
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Recruiting
      • Hospital Universitario Puerta de Hierro Majadahonda
      • Contact: Pedro Jose Torrijos Garrido, MD, PhD; Phone Number: +34 91 191 74 85; Email: pedrojose.torrijos@salud.madrid.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Pedro-José Torrijos-Garrido
• Investigators: Principal Investigator: Pedro J Torrijos Garrido, MD, PhD, Hospital Universitario Puerta De Hierro

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: September 29, 2022
• First Submitted That Met QC Criteria: October 4, 2022
• First Posted (Actual): October 7, 2022

Study Record Updates

• Last Update Posted (Actual): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Tibial fracture; 3D printing
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Knee Fractures; Tibial Fractures; Fractures, Bone; Tibial Plateau Fractures
• Other Study ID Numbers: TIBIA3D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No