NCT05571449

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 7, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

February 29, 2024

Status Verified

February 1, 2024

Enrollment Period

2 years

First QC Date

September 29, 2022

Last Update Submit

February 27, 2024

Conditions

Tibial Plateau Fracture

Keywords

3D printingTibial fracture

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Ease of surgical planning with 3d printing

    Week 1

  • Complications

    Week 1 - 12 months

Other Outcomes (4)

  • Visual Analogis Scale for Pain

    6 weeks - 12 months

  • KOOS Questionarie

    6 weeks - 12 months

  • EuroQol-5D Questionarie

    6 weeks - 12 months

  • +1 more other outcomes

Study Arms (2)

Experimental group

EXPERIMENTAL

Planning of tibial plateau fracture osteosynthesis by using a three-dimensional model of the fracture.

Procedure: Open reduction and internal fixationProcedure: Standard osteosynthesis planningProcedure: 3-D model osteosynthesis planning

Control group

OTHER

Standard planning of tibial plateau fracture osteosynthesis (by plain radiography and computed tomography imaging).

Procedure: Open reduction and internal fixationProcedure: Standard osteosynthesis planning

Interventions

Open reduction and internal fixationPROCEDURE

Internal fixation of the fracture

Control groupExperimental group
Standard osteosynthesis planningPROCEDURE

Plain radiograph and CT images are used

Control groupExperimental group
3-D model osteosynthesis planningPROCEDURE

A 3D plastic model made from CT images is used

Experimental group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, 28222, Spain

RECRUITING

MeSH Terms

Conditions

Tibial Plateau FracturesTibial Fractures

Interventions

Open Fracture ReductionFracture Fixation, Internal

Condition Hierarchy (Ancestors)

Knee FracturesFractures, BoneWounds and InjuriesKnee InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Fracture FixationOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Study Officials

  • Pedro J Torrijos Garrido, MD, PhD

    Hospital Universitario Puerta de Hierro

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pedro J Torrijos Garrido, MD, PhD

CONTACT

+34 91 191 74 85pedrojose.torrijos@salud.madrid.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 29, 2022

First Posted

October 7, 2022

Study Start

October 1, 2022

Primary Completion

October 1, 2024

Study Completion

October 1, 2025

Last Updated

February 29, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)