Clinical Trial

Assessment of the Verus Frame in Tibial Intramedullary Nailing

Not Yet Recruiting
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Summary
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.
Trial Details
NCT Number NCT07362121
Lead Sponsor Hemitec Finland Oy
Conditions Tibial Fracture
Enrollment 25 participants
Start Date 2026-05-01
Primary Completion 2027-05 (estimated)
Study Completion 2027-05 (estimated)
Updated on ClinicalTrials.gov 2026-01-23