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Can a 3D-Printed copy of a broken knee make surgery faster?

NCT ID NCT05571449

Symptom relief Sponsor: Pedro-José Torrijos-Garrido Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 25, 2026 · Last updated Sep 25, 2026

Summary

Researchers are testing whether surgeons who plan tibial plateau fracture surgery using a 3D-printed plastic model of the broken bone operate faster and use less X-ray imaging than surgeons who plan with standard X-rays and CT scans. The trial enrolls 35 adults with a tibial plateau fracture that needs surgery. Everyone receives the same operation, open reduction and internal fixation, but half the cases are planned with the 3D model and half with standard imaging. The study tracks surgical time and fluoroscopy time during the procedure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
3D-printed plastic models of the fractured tibial plateau, used to plan surgery
What this could lead to
If 3D-printed models help, surgeons could plan complex knee fractures faster and with less X-ray exposure during the operation.
What could go wrong
The trial is small, with 35 participants, and it measures surgical time and X-ray use rather than how well patients recover. Results may not apply to other hospitals or fracture types.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

35 people

The number who actually took part.

Started

Oct 2022

Finished

Nov 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

tibia fracture Tibial Plateau Fractures

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Tibial plateau fracture

Contacts and locations

Locations

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222, Spain

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