Assessment of the Verus Frame in Tibial Intramedullary Nailing
Starting soon · Not applicable
Conditions studied: Tibial Fracture
In brief
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.
Key facts
- Study ID
- NCT07362121
- Run by
- Hemitec Finland Oy
- People needed
- 25
- Starts
- 2026-05-01
- Expected to finish
- 2027-05-01
- Last updated by the study team
- 2026-01-23
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Tibial fracture to be operated by suprapatellar intramedullary nailing technique
- 18-80 years old
- Signed informed consent
You may not qualify if…
- 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
Where it is running
- Turku University Hospital — Turku, Finland
Full record on ClinicalTrials.gov
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