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Robots take on bone setting: a trial tests precision surgery for broken ankles

NCT ID NCT07733271

Disease control Sponsor: Beijing Jishuitan Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time

Summary

This trial compares robot-assisted surgery to traditional methods for fixing a specific type of broken ankle (distal tibial fracture). The robot uses artificial intelligence to plan and perform the bone realignment, aiming for more accurate placement and less radiation exposure. Sixty adults with closed, acute fractures will be randomly assigned to either robot-assisted or conventional surgery. The main goal is to see if the robot leads to better bone alignment after 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
Robot-assisted closed reduction and internal fixation using an intelligent robotic system with deep-learning-based bone segmentation and automated reduction planning
What this could lead to
If successful, this robotic system could make fracture surgery more precise and consistent, potentially improving recovery and reducing the need for repeat procedures.
What could go wrong
This is a small, early-stage trial with only 60 participants, so results may not apply to all patients. The robot may not perform as well as an experienced surgeon in complex cases.

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

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Dec 2028

An estimate. End dates often move.

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 80 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: * Unilateral, acute, closed distal tibial fractures (Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association AO/OTA 43-A) * Time from injury to surgery \< 21 days * Able to walk independently before injury (assistive devices allowed) Exclusion Criteria: * Open fractures or multiple severe traumas requiring priority treatment * Asymmetrical lower extremities, or prior malunion of the ipsilateral tibia, or pre-existing deformities significantly affecting rotation/length evaluation * Ipsilateral fractures combined with other sites * Pathological fractures (tumor/metabolic) * Prior complex implants in place or previous surgeries significantly affecting evaluation * Active infection or severe systemic medical contraindications (unable to tolerate anesthesia/surgery) * Cognitive impairment, poor compliance, pregnancy, or lactation * Poor local skin conditions (e.g., obvious blisters, severe soft tissue injury) * Deemed unsuitable by the investigator (e.g., unable to follow up as planned) or refused randomization/enrollment

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Conditions

The condition(s) this trial relates to.

tibia fracture

As listed by the trial registrant

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

Distal tibial fracture Tibial fractures

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aerospace Center Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100035, China

  • Beijing Jishuitan Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100035, China

More trials for these conditions

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