NCT07362121

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
12mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
May 2026May 2027

First Submitted

Initial submission to the registry

January 15, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

January 15, 2026

Last Update Submit

January 15, 2026

Conditions

Tibial Fracture

Outcome Measures

Primary Outcomes (1)

  • Post-operative X-ray measurement of alignment

    Varus/valgus alignment measurement and anterior/posterior angulation measurement

    Within two days after operation

Study Arms (1)

Verus_patients

EXPERIMENTAL

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.

Device: Verus frame to stabilize tibia

Interventions

Verus frame to stabilize tibiaDEVICE

Verus is used during tibial intramedullary nailing surgery.

Verus_patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Tibial fracture to be operated by suprapatellar intramedullary nailing technique
  • years old
  • Signed informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University Hospital

Turku, Finland

Location

MeSH Terms

Conditions

Tibial Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesLeg Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2026

First Posted

January 23, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

January 23, 2026

Record last verified: 2026-01

Locations

FI(1)