Assessment of the Verus Frame in Tibial Intramedullary Nailing

Hemitec Finland Oy

Status: Begins enrollment in 2 months

Conditions: Tibial Fracture

Treatments: Device: Verus frame to stabilize tibia

Study type: Interventional

Funder types: Industry

Identifiers

NCT07362121

VERUS-001_PMCFSP

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Verus_patients

Experimental group

Description:

Verus is intended to be used as a support of leg during orthopaedic surgery. The post-operative alignment and rotation will be determined by x-ray and computed tomography scan.

Treatment:

Device: Verus frame to stabilize tibia