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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 25
- Locations
- 2
- Primary Endpoint
- Post-operative X-ray measurement of alignment
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Tibial fracture to be operated by suprapatellar intramedullary nailing technique
- •18-80 years old
- •Signed informed consent
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: Verus frame to stabilize tibia (Device)
Outcomes
Primary Outcomes
Post-operative X-ray measurement of alignment
Time Frame: Within two days after operation
Varus/valgus alignment measurement and anterior/posterior angulation measurement
Secondary Outcomes
No secondary outcomes reported