Assessment of the Verus Frame in Tibial Intramedullary Nailing
ConditionTibial Fracture
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHemitec Finland Oy
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Tibial fracture to be operated by suprapatellar intramedullary nailing technique
18-80 years old
Signed informed consent
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Verus frame to stabilize tibia
DeviceVerus is used during tibial intramedullary nailing surgery.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Verus_patientsExperimental treatment 1 intervention
Trial outcomes
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 operationSponsors and contacts
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Source ClinicalTrials.gov