Verus frame in tibial nailing for precise alignment
Official title: Assessment of the Verus Frame as a Support for the Leg in Orthopaedic Surgery (Intramedullary Nailing) of Tibial Fracture in Adults. A Prospective, Single-arm, Interventional Post-market Clinical Investigation With AO Foundation Approved Acceptance Criteria and a Retrospective Registry Control Group.
Run by Hemitec Finland Oy · NCT07362121 · Data updated 2026-11-12
This PMCF study tests whether the Verus frame helps surgeons get the tibia aligned and rotated correctly during suprapatellar tibial nailing in adults with tibial fractures.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 25 (estimated) |
| Sponsor | Hemitec Finland Oy Industry-sponsored |
| Locations | 1 site (Turku) |
| Status | Recruiting |
| Started | September 2, 2026 |
| Main results expected | September 2027 |
| Study ends | September 2027 |
| Registry record updated | September 18, 2026 |
| Trial ID | NCT07362121 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 to 80 with a tibial fracture eligible for suprapatellar intramedullary nailing.
✕Probably not a fit
Patients with contraindications to intramedullary fixation, open fractures with extensive soft tissue damage, pregnancy or lactation, polytrauma, or prior tibia fracture may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, single-arm PMCF study using a registry-based control to evaluate the Verus frame in tibial intramedullary nailing. The focus is on achieving accurate tibial rotation and alignment and on safety. Results will be compared to AO-approved criteria to ensure alignment quality and device performance meet regulatory expectations. Tibial nailing is the standard treatment for tibial fractures, where proper alignment is linked to better recovery and outcomes. The study is conducted at Turku University Hospital with Hemitec Finland Oy as the lead sponsor.
Why it matters
Potential benefit: If successful, the Verus frame could improve alignment accuracy and potentially enhance recovery for patients undergoing tibial nailing.
How similar studies have gone: Previous studies with similar alignment-focused devices have shown mixed but encouraging results; this study explores a new PMCF approach with registry-based comparison.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Turku University Hospital
Turku, Finland Recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Criteria-based Rehabilitation After Tibial Fracture Fixation
This trial tests a structured, criteria-driven rehabilitation plan against usual physiotherapy after tibial fracture surgery to see if it improves leg function.
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Elastic nailing with Kirschner wires versus plate fixation for distal tibial fractures in adolescents
This trial tests whether elastic stable intramedullary nailing with Kirschner wires works as well as plate fixation for fixing distal tibial fractures in kids aged 10 to 16.
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Comparing the standard tibial intramedullary nail with a micromotion tibial nail for unstable tibial fractures.
This trial will test whether a micromotion tibial nail helps adults with unstable tibial fractures heal faster and have fewer complications than a standard tibial nail.
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.