Assessment of the Verus Frame in Tibial Intramedullary Nailing

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.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07362121

Enrollment

Registered

2026-01-23

Start date

2026-05-01

Completion date

2027-05-01

Last updated

2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tibial Fracture

Brief summary

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

DEVICEVerus frame to stabilize tibia

Verus is used during tibial intramedullary nailing surgery.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Post-operative X-ray measurement of alignment	Within two days after operation	Varus/valgus alignment measurement and anterior/posterior angulation measurement

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026