NCT01830712已完成不适用
A Long-Term Assessment of Physical Activity, Range of Motion, and Functional Status Following Elective Orthopedic Surgery in Hemophilia Patients With Inhibitors. A Retrospective Follow-up Assessment to F7HAEM/USA/3/USA and F7HAEM/USA/4/USA
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Long-term changes in general mobility/ambulation/activity
研究概览
简要总结
This study is conducted in the United States of America (USA). The aim of this study is to assess the long-term (5+ years) postoperative functional outcomes of elective orthopaedic surgery (EOS) patients from previously reported studies F7HAEM/USA/3/USA and F7HAEM/USA/4/USA (NCT01561391) and furthermore to assess the impact of EOS on psychosocial outcomes, frequency of bleeding episodes and durability of joint surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Haemophilia patients with inhibitors who have had EOS during their participation in F7HAEM/USA/3/USA and F7HAEM/USA/4/USA (NCT01561391)
排除标准
- 未提供
研究组 & 干预措施
Chart review
干预措施: eptacog alfa (activated) (Drug)
结局指标
主要结局
Long-term changes in general mobility/ambulation/activity
时间窗: From pre-operative (baseline) functional status and up to at least 5 years
次要结局
- Long-term changes in employment status(From pre-operative (baseline) functional status and up to at least 5 years)
- Long-term changes in work/school attendance(From pre-operative (baseline) functional status and up to at least 5 years)
- Long-term changes in complications related to surgical procedure and/or prostheses(From pre-operative (baseline) functional status and up to at least 5 years)
- Long-term changes in body mass index (BMI)(From pre-operative (baseline) functional status and up to at least 5 years)
- Overall frequency of bleeding episodes(From pre-operative (baseline) functional status and up to at least 5 years)
- Number of joint infections(From pre-operative (baseline) functional status and up to at least 5 years)
- Number of treatment types (on demand, prophylaxis)(From pre-operative (baseline) functional status and up to at least 5 years)
研究者
研究点 (1)
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