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Assessment of the Verus Frame in Tibial Intramedullary Nailing

NCT07362121 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-01-23

No results posted yet for this study

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.

Conditions

  • Tibial Fracture

Interventions

DEVICE

Verus frame to stabilize tibia

Verus is used during tibial intramedullary nailing surgery.

Sponsors & Collaborators

  • Hemitec Finland Oy

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2027-05-31
Completion
2027-05-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07362121 on ClinicalTrials.gov