Assessment of the Verus Frame in Tibial Intramedullary Nailing

N/ANot Yet RecruitingNCT07362121

Hemitec Finland Oy25 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Tibial Fracture

Interventions

Verus frame to stabilize tibiaDEVICE

Verus is used during tibial intramedullary nailing surgery.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Turku University Hospital

Turku, Finland

Outcomes

Primary Outcomes

Post-operative X-ray measurement of alignment

Varus/valgus alignment measurement and anterior/posterior angulation measurement

Time frame: Within two days after operation

Data from ClinicalTrials.gov

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