Unipolar Versus Bipolar Interlocking in Humeral Shaft Fractures in Adults
Recruiting
Phase 3
Interventional Study
Humeral Shaft Fracture
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 390 (estimated)
- Sponsor
- Centre Hospitalier Universitaire Dijon · Other
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About This Trial
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 stres…
Trial Locations
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Eligibility Criteria
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…
Contacts