Assessment of the Verus Frame in Tibial Intramedullary Nailing

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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Key information

Conditions

Tibial Fracture Fractures, Bone Leg Injuries Tibial Fractures Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Turku University Hospital

Turku, Finland

Location contact

Head of traumatology

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Verus frame to stabilize tibia

Device

Verus is used during tibial intramedullary nailing surgery.

Primary outcomes

Post-operative X-ray measurement of alignment

Time frame: Within two days after operation

Varus/valgus alignment measurement and anterior/posterior angulation measurement

Sponsors and collaborators

Lead sponsor

Hemitec Finland Oy

Industry

Registry information

Official study 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.

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Jan 23, 2026
Registry last updated: Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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