Safety, Efficacy, & Use of ViviGen Cellular Bone Matrix Allograft in Orthopaedic Fracture Care: A Multi-Center Prospective Registry and Retrospective Data Collection Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 8
- 主要终点
- Reintervention Rate
研究概览
简要总结
Prospective registry and retrospective data collection study to assess the efficacy and safety of Vivigen Cellular Bone Matrix (Vivigen) in orthopaedic trauma patients who require bone grafting in the acute, delayed, non-union fracture as well as use in fusion procedure settings.
详细描述
The prospective registry study and retrospective data collection study is planned to assess the efficacy and safety of Vivigen Cellular Bone Matrix (Vivigen) in orthopaedic trauma patients who require bone grafting in the acute, delayed, non-union fracture as well as use in fusion procedure settings.
Patients will be assessed at hospital discharge, 6 weeks, 3 months, 6 months, 12 months and 24 months after treatment of a traumatic fracture with a bone graft.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prospective Cohort Inclusion Criteria:
- •Any skeletally mature patient treated with Vivigen bone graft in the setting of an acute fracture, delayed, non-union or fusion setting will be eligible for inclusion.
- •Retrospective Cohort Inclusion Criteria:
- •- Any skeletally mature patient treated with adjunct bone graft in the setting of an acute fracture, delayed, non-union or fusion setting will eligible for inclusion.
- •Prospective Cohort
排除标准
- •Patients unable to understand either an English or Spanish consent will be excluded.
- •Patients unable to consent secondary to dementia and/or other mental/psychiatric diagnoses will be excluded.
研究组 & 干预措施
Prospective Registry
Treatment for diagnoses of long bone non-union involving the tibia or femur and other nonunion diagnosis (i.e. clavicle, humerus, and femur) with Vivigen Cellular Bone Matrix
干预措施: Vivigen Cellular Bone Matrix (Other)
Retrospective Data Collection
Treatment of diagnoses of long bone non-union involving the tibia or femur and other nonunion diagnosis (i.e. clavicle, humerus, and femur) with adjunct bone graft utilized in the acute, delayed, non-union and fusion settings.
结局指标
主要结局
Reintervention Rate
时间窗: 24 months
the proportion of patients requiring secondary intervention (return to the operating room) within twelve months after definitive wound closure
次要结局
- Patient Reported Outcome Measurement Information System (PROMIS) Scores(24 months)
- Fusion Rate(24 months)