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Unipolar Versus Bipolar Interlocking in Humeral Shaft Fractures in Adults

RecruitingPhase 3Ages 18 Years - anyAllCentre Hospitalier Universitaire Dijon
NCT05877014 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Shaft fractures account for 20% of humeral fractures and 3% of all adult fractures in France, with an estimated incidence of 13 to 20/100,000 people. Men aged 21 to 30 years and women aged 60 to 80 years are particularly affected. Intramedullary nailing is among the standard treatments for humeral shaft fractures (when surgery is required). Once inserted, the nail is locked in order to limit stress on the fractured bone, as well as possible secondary rotational displacements or malunion. Bipolar interlocking (BI) is typically performed on both sides (proximal and distal) of the fracture site. This procedure is performed under radiological control, exposing the patient and care team to radiation (during the entire procedure). The objective of the treatment is to obtain consolidation of the fracture within 12 months, and to limit the occurrence of irreversible complications such as malunio

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📋 Eligibility rules (as published)
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.
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What it tests

  • questionnaires
  • scanner
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Where

1 site
Chu Dijon Bourgogne
Dijon, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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