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Assessment of the Verus Frame in Tibial Intramedullary Nailing

RecruitingNAAges 18 Years - 80 YearsAllHemitec Finland Oy
NCT07362121 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This prospective, single-arm Post-Market Clinical Follow-Up (PMCF) study, utilizing a registry-based control group, will assess the Verus frame's effectiveness in achieving precise tibial rotation and alignment during intramedullary nailing procedure, as well as safety of the device. The results will be compared to AO-approved criteria to ensure comprehensive evaluation of its new benefits, regulatory compliance, and continued clinical use. Tibial intramedullary nailing is the gold standard for tibial fracture fixation, where accurate alignment and rotation are crucial for optimal recovery and long-term outcomes.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Tibial fracture to be operated by suprapatellar intramedullary nailing technique * 18-80 years old * Signed informed consent Exclusion Criteria: * Situations where intramedullary fixation is otherwise contraindicated, e.g., active or potential infection, osteoporosis or where a patient's cooperation cannot be guaranteed. * Pregnancy, breastfeeding * Open fractures with severe soft tissue damage * Polytrauma * Previous tibia fracture
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What it tests

  • Verus frame to stabilize tibia
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Where

1 site
Turku University Hospital
Turku, Finland
🤝 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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