ClinicalTrials.gg
RecruitingNCT07362121Updated Sep 18, 2026

Assessment of the Verus Frame in Tibial Intramedullary Nailing

An interventional study of Verus frame to stabilize tibia in Tibial Fracture, sponsored by Hemitec Finland Oy. Recruiting at 1 site in Finland. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-18.

Sponsored by Hemitec Finland Oy · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2026; still recruiting 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

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.

02

Conditions studied

  • Tibial Fracture

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03

In context

Tibial Fractures

135 studies on the registry are indexed under Tibial Fractures; 37 are open to participants now.

This study's planned enrollment of 25 is below the median of 65 across 91 interventional studies indexed under Tibial Fractures.

Browse Tibial Fractures studies →

Lead sponsor

This is the only study on the registry with Hemitec Finland Oy as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Tibial fracture to be operated by suprapatellar intramedullary nailing technique
  • 18-80 years old
  • Signed

Exclusion criteria

Exclusion Criteria:

  • Situations where intramedullary fixation is otherwise , 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    Verus_patients

    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

  • DeviceVerus frame to stabilize tibia

    Verus is used during tibial intramedullary nailing surgery.

06

What researchers measure

Primary outcomes

  1. Post-operative X-ray measurement of alignment

    Varus/valgus alignment measurement and anterior/posterior angulation measurement

    Time frame: Within two days after operation

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2026 (actual). Primary completion is estimated for Sep 2027, 12 months after the start.

Of 39 interventional studies with no phase under Tibial Fractures, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 80. This study's planned 12 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 15, 2026
First posted
Jan 23, 2026
StartActual
Sep 2, 2026
Primary completionEst.
Sep 2027
CompletionEst.
Sep 2027
Last update
Sep 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07362121
Lead sponsor
Hemitec Finland Oy
Responsible party
Sponsor
First posted
Jan 23, 2026
Start date
Sep 2, 2026
Primary completion
Sep 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Sep 18, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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