Comparing unipolar and bipolar interlocking techniques for humeral shaft fractures
Official title: Unipolar Versus Bipolar Interlocking in Humeral Shaft Fractures in Adults
Run by Centre Hospitalier Universitaire Dijon · NCT05877014 · Data updated 2026-11-12
This study is testing whether two different surgical techniques for fixing arm fractures work better than each other in helping adults heal and avoid complications.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 390 (estimated) |
| Sponsor | Centre Hospitalier Universitaire Dijon Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Dijon) |
| Status | Recruiting |
| Started | July 3, 2023 |
| Main results expected | September 2027 |
| Study ends | September 2027 |
| Registry record updated | July 30, 2026 |
| Trial ID | NCT05877014 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with a diagnosed humeral shaft fracture requiring surgical intervention.
✕Probably not a fit
Patients with pathologic fractures, brachial plexus injuries, or those undergoing revision surgery for humeral fractures may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to compare the effectiveness of unipolar interlocking versus bipolar interlocking techniques in treating humeral shaft fractures in adults. The study will involve patients who require surgical treatment with intramedullary nailing and will assess the consolidation of the fracture within 12 months, as well as the occurrence of complications such as malunion or nonunion. Participants will be monitored through questionnaires and scans to evaluate their recovery and outcomes. The trial is conducted under strict eligibility criteria to ensure the safety and relevance of the findings.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical techniques that enhance recovery and reduce complications for patients with humeral shaft fractures.
How similar studies have gone: While there is existing research on intramedullary nailing techniques, the specific comparison of unipolar versus bipolar interlocking in this context is novel.
Who can join: the full rules
Show full inclusion / exclusion 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 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.
Where it's running
-
Chu Dijon Bourgogne
Dijon, France Recruiting
Study contacts
- Study coordinator: Pierre MARTZ
- Email: pierre.martz@chu-dijon.fr
- Phone: 0380293307
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.