Assessment of the Verus Frame in Tibial Intramedullary Nailing
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Verus frame to stabilize tibia.
- Who it may be relevant to
- Registry conditions: Tibial Fracture. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
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.
Interventions
- Device Verus frame to stabilize tibia
Verus is used during tibial intramedullary nailing surgery.
Primary outcome measures
- Post-operative X-ray measurement of alignment [Time frame: Within two days after operation]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Finland · 1 center
- Turku University Hospital — Turku
Identifiers
NCT: NCT07362121 · VERUS-001_PMCFSP