NCT04138017已完成4 期
Clinical and Radiographic Outcomes Using ViviGen® Cellular Bone Matrix for Complex Hindfoot Arthrodesis
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Union Rates
研究概览
简要总结
To evaluate the fusion status of the hindfoot bones after receiving the ViviGen graft, an FDA approved cellular bone matrix. This is used in a population indicated for hindfoot arthrodesis as an alternative to an autograft.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient with prescribed standard of care unilateral hindfoot ankle arthrodesis procedure
- •Age 18-80
- •Willing to complete all follow up evaluations
排除标准
- •Prior infection at site of planned arthrodesis
- •Prior arthrodesis procedure
- •Inability to maintain non-weight bearing status
- •Bone defect requiring more than 10 cc of bone graft material
- •Known Vitamin D deficiency with a Vitamin D level of <30ng/ml 1 week prior to surgery
- •Inadequate bone stock to allow for rigid internal fixation
- •Hemoglobin A1c greater than 8.0%
- •Tobacco or Nicotine use 6 weeks prior to surgery
- •BMI greater than 40
结局指标
主要结局
Union Rates
时间窗: 12 months
Radiographic evidence of successful arthrodesis confirmed on Computed Tomography (CT) scan defined by \>50%. Results are for total number of joints fused which exceeds the number of participants due to some subjects having multiple joints fused.
次要结局
- Failure of Hardware or Obvious Non-union(12 months)
- Foot and Ankle Ability Measure (FAAM) - Activities of Daily Living (ADL) Subscale(baseline, 3 month, 6 month, 1 year)
- Vitamin D Levels(baseline, 6 months)
- American Orthopaedic Foot and Ankle Society(AOFAS) Hindfoot Score(baseline, 3 month, 6 month, 1 year)
研究者
Joseph Park
Associate Professor, Department of Orthopaedic Surgery
University of Virginia
研究点 (1)
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