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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Verus frame to stabilize tibia | Device | Verus is used during tibial intramedullary nailing surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative X-ray measurement of alignment | Varus/valgus alignment measurement and anterior/posterior angulation measurement | Within two days after operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Turku University Hospital | Turku | Finland |
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| ID | Term |
|---|---|
| D013978 | Tibial Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
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