Can robots perfectly align broken femurs?
NCT ID NCT07738380
First seen Jul 31, 2026 · Last updated Jul 31, 2026
Summary
This trial tests whether robot-assisted surgery can align broken thigh bones (femur fractures) more precisely than traditional surgeon-performed methods. Adults with a closed femur fracture are randomly assigned to receive either robot-assisted or conventional reduction, followed by standard internal fixation. The study measures how well the bone fragments align, surgical time, blood loss, healing, and functional recovery over a year. The goal is to see if robotic assistance improves outcomes and reduces trauma.
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 procedure
- What this could lead to
- If successful, this could make femur fracture surgery more precise, potentially improving bone alignment and speeding up recovery.
- What could go wrong
- The trial is relatively small and early, so results may not apply to all patients. Robot-assisted surgery may not always outperform traditional methods and could carry technical risks.
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
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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
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Age 18 to 80 years, inclusive. * Unilateral, acute, closed femoral shaft fracture. * AO/OTA classification 32-A, 32-B, or 32-C femoral shaft fracture. * Time from injury to surgery no more than 21 days. * Ability to walk independently before injury, with or without assistive devices. * Ability to provide written informed consent. Exclusion Criteria: * Open fracture. * Multiple severe trauma requiring immediate priority management. * Asymmetry of the lower limbs. * History of ipsilateral femoral shaft malunion. * History of ipsilateral femoral deformity that significantly affects assessment of - limb rotation or length. * Ipsilateral fracture at another site. * Pathological fracture caused by tumor, metabolic bone disease, or other underlying bone pathology. * Complex hardware from previous ipsilateral surgery. * History of ipsilateral surgery that significantly affects clinical or radiographic evaluation. * Active infection. * Severe underlying medical condition that makes the patient unable to tolerate surgery. * Cognitive impairment that prevents study participation or follow-up. * Poor compliance with study procedures or follow-up. * Pregnancy or lactation. * Judged by the investigators to be unsuitable for enrollment. * Unable to complete the planned follow-up period. * Refusal to undergo randomization. * Refusal to participate in the clinical study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Beijing Jishuitan Hospital
RECRUITINGBeijing, Beijing Municipality, 100035, China
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