Tibial FractureNCT07362121
Assessment of the Verus Frame in Tibial Intramedullary Nailing
A study testing Verus frame to stabilize tibia in people with Tibial Fracture, run by Hemitec Finland Oy at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tibial Fracture
- What is being tested?
- Verus frame to stabilize tibia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFinland
- Study dates
- 2 Sep 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Tibial fracture to be operated by suprapatellar intramedullary nailing technique
- 18-80 years old
- Signed informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Turku University Hospital
Turku
Head of traumatology, 02 313 0000, firstname.lastname@varha.fi
About this study
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.
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
- Being tested
- Verus frame to stabilize tibia
- Medical subject headings
- Tibial Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verus frame to stabilize tibiaDevice
Verus is used during tibial intramedullary nailing surgery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Verus frame to stabilize tibia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative X-ray measurement of alignment
Varus/valgus alignment measurement and anterior/posterior angulation measurement
Measured: Within two days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start2 Sep 2026
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tibial FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hemitec Finland Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07362121
- Sponsor's protocol ID
- VERUS-001_PMCFSP
- Status last verified
- Sep 2026
- First submitted
- 15 Jan 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07362121
- Acronym / sponsor ID
- VERUS-001_PMCFSP
- Conditions
- Tibial Fracture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Hemitec Finland OyIndustry (pharma, biotech, devices)
- Study start
- 2 Sep 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Verus_patients | Experimental | Device: Verus frame to stabilize tibiaVerus 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Tibial fracture to be operated by suprapatellar intramedullary nailing technique
- 18-80 years old
- Signed informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Verus frame to stabilize tibiaVerus is used during tibial intramedullary nailing surgery. | Device | Verus_patients |
Primary outcome
Post-operative X-ray measurement of alignment
Time frame: Within two days after operation
Varus/valgus alignment measurement and anterior/posterior angulation measurement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verus frame to stabilize tibia in people with Tibial Fracture, run by Hemitec Finland Oy at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative X-ray measurement of alignment (time frame: Within two days after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.