Could a simpler surgical locking method reduce nerve damage in broken arm bones?
NCT ID NCT05877014
First seen Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time
Summary
This trial tests whether locking a metal nail only on one side of a broken upper arm bone (unipolar interlocking) works as well as locking it on both sides (bipolar interlocking). The simpler technique may lower the risk of nerve injury, infection, and radiation exposure. About 390 adults with humeral shaft fractures who need surgery will be randomly assigned to one of the two methods and followed for a year to see if the bone heals properly.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- surgical technique: unipolar interlocking versus bipolar interlocking for intramedullary nailing
- What this could lead to
- If unipolar interlocking works as well as the standard technique, it could reduce nerve damage, infection, and radiation exposure during surgery.
- What could go wrong
- This is a single-center trial, and unipolar locking may lead to malunion requiring additional surgery. Results may not apply to all 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
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
About 390 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jul 2023
- Expected to finish
-
Sep 2027
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 years and older
- 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 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: * Patient with written consent * Patient ≥18 years of age with a diagnosis of humeral shaft fracture (all types in the AO classification) requiring surgical treatment with intramedullary nailing Exclusion Criteria: * Person not affiliated to national health insurance * Patient unable to attend all study visits * Patient with a pathologic fracture * Patient with a post-traumatic brachial plexus injury at the time of inclusion * Patient under court protection, guardianship or legal guardianship * Pregnant, parturient or breastfeeding woman * Patient admitted for revision surgery of a humerus fracture (insufficient healing or complication) * Patient with an acute or chronic, unstable or poorly controlled disease that may interfere with the evaluation of the study objective, as determined by the investigator.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Humeral shaft fracture are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
Chu Dijon Bourgogne
RECRUITINGDijon, 21000, France