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.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Post-operative X-ray measurement of alignment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tibial fracture to be operated by suprapatellar intramedullary nailing technique
- •18-80 years old
- •Signed informed consent
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Verus frame to stabilize tibia (Device)
结局指标
主要结局
Post-operative X-ray measurement of alignment
时间窗: Within two days after operation
Varus/valgus alignment measurement and anterior/posterior angulation measurement
次要结局
未报告次要终点