Tibial Plateau FractureNCT05571449
Efficacy of the Use of 3D Printing Models in the Treatment of Tibial Plateau Fractures: a Randomized Clinical Trial
A study testing Open reduction and internal fixation, Standard osteosynthesis planning and 3-D model osteosynthesis planning in people with Tibial Plateau Fracture, run by Pedro-José Torrijos-Garrido at 1 site in Spain.
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 Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Tibial Plateau Fracture
- What is being tested?
- Open reduction and internal fixation, Standard osteosynthesis planning and 3-D model osteosynthesis planning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2022to 6 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222
About this study
Official title: 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
Read the 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.
- Conditions
- Tibial Plateau Fracture
- Being tested
- Open reduction and internal fixation, Standard osteosynthesis planning, 3-D model osteosynthesis planning
- Keywords
- 3D printing, Tibial fracture
- Medical subject headings
- Tibial Plateau Fractures, Tibial Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open reduction and internal fixationProcedure or surgery
Internal fixation of the fracture
Standard osteosynthesis planningProcedure or surgery
Plain radiograph and CT images are used
3-D model osteosynthesis planningProcedure or surgery
A 3D plastic model made from CT images is used
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Planning of tibial plateau fracture osteosynthesis by using a three-dimensional model of the fracture. Receives: Procedure: Open reduction and internal fixation; Procedure: Standard osteosynthesis planning; Procedure: 3-D model osteosynthesis planning |
| Control group | Other | Standard planning of tibial plateau fracture osteosynthesis (by plain radiography and computed tomography imaging). Receives: Procedure: Open reduction and internal fixation; Procedure: Standard osteosynthesis planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical time
Surgical time will include the time from skin incision to wound closure
Measured: Week 1
Fluoroscopy time.
Intraoperative fluoroscopy time will be counted after incision and before wound closure.
Measured: Week 1
Secondary outcomes (2)
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
Measured: 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.
Measured: Week 1 - 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start1 Oct 2022
- Primary completion6 Nov 2024
- Study completion6 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tibial Plateau FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pedro-José Torrijos-Garrido
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pedro-José Torrijos-Garrido, Puerta de Hierro University Hospital
- Investigators
- Pedro J Torrijos Garrido, MD, PhD, Principal investigator, Hospital Universitario Puerta de Hierro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05571449
- Sponsor's protocol ID
- TIBIA3D
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2022
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Garcia Cantarero M, Torrijos Garrido PJ, de Caceres Velasco AI, Sanchez Mallo O. Efficacy of the use of 3D printing models in the treatment of tibial plateau fractures: a pilot randomized clinical trial. J Orthop Surg Res. 2026 May 13;21(1):419. doi: 10.1186/s13018-026-06950-w.
PubMed 42129866
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Use of 3D Printing Models in the Treatment of Tibial Plateau Fractures: a Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05571449
- Acronym / sponsor ID
- TIBIA3D
- Conditions
- Tibial Plateau Fracture
- Keywords
- 3D printing, Tibial fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Pedro-José Torrijos-GarridoUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 6 Nov 2024 (actual)
- Study completion
- 6 Nov 2024 (actual)
- First posted
- 7 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Procedure: Open reduction and internal fixation, Procedure: Standard osteosynthesis planning, Procedure: 3-D model osteosynthesis planningPlanning of tibial plateau fracture osteosynthesis by using a three-dimensional model of the fracture. |
| Control group | Other | Procedure: Open reduction and internal fixation, Procedure: Standard osteosynthesis planningStandard planning of tibial plateau fracture osteosynthesis (by plain radiography and computed tomography imaging). |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open reduction and internal fixationInternal fixation of the fracture | Procedure or surgery | Control group, Experimental group |
| Standard osteosynthesis planningPlain radiograph and CT images are used | Procedure or surgery | Control group, Experimental group |
| 3-D model osteosynthesis planningA 3D plastic model made from CT images is used | Procedure or surgery | Experimental group |
Primary outcome
Surgical time
Time frame: Week 1
Surgical time will include the time from skin incision to wound closure
Fluoroscopy time.
Time frame: Week 1
Intraoperative fluoroscopy time will be counted after incision and before wound closure.
2 secondary outcomes
Ease of surgical planning with 3d printing
Time frame: Week 1
Complications
Time frame: Week 1 - 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Results publication: PubMed 42129866Garcia Cantarero M, Torrijos Garrido PJ, de Caceres Velasco AI, Sanchez Mallo O. Efficacy of the use of 3D printing models in the treatment of tibial plateau fractures: a pilot randomized clinical trial. J Orthop Surg Res. 2026 May 13;21(1):419. doi: 10.1186/s13018-026-06950-w.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro J Torrijos Garrido, MD, PhD principal investigator
Hospital Universitario Puerta de Hierro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open reduction and internal fixation, Standard osteosynthesis planning and 3-D model osteosynthesis planning in people with Tibial Plateau Fracture, run by Pedro-José Torrijos-Garrido at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical time (time frame: Week 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05571449, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.