Discovery Elbow Long-Term Survivorship Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 29
- 试验地点
- 4
- 主要终点
- Patient Derived American Shoulder and Elbow Society (ASES) Pain Score
研究概览
简要总结
The Discovery™ Elbow Multi-Center Prospective Study (5-year Study) patients will be consented at the two year or next scheduled follow-up period for the early-enrolled patients.
详细描述
Eligibility: Patient(s) must be enrolled in the Discovery Multi-Center Prospective Study. The patient must consent to participation in the Discovery Long-term Survivorship Study.
In order to continue to follow the multi-center subjects long-term Biomet would like to extend the follow-up to include annual follow-ups from 10 to 15 years to document long-term survivorship. The annual follow-up will be obtained by sending annual questionnaire directly to the patients by mail. The Patient ASES questionnaire and survivorship data questions will be collected.
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
- •Participant in the Discovery Elbow Multi-center Study
- •Consent to participate in the Discovery Elbow Long-Term Survivorship Study
排除标准
- •Patient is not a Discovery Elbow Multi-center Participant
- •Patient does not provide consent for the Discovery Elbow Long-term Survivorship Study
结局指标
主要结局
Patient Derived American Shoulder and Elbow Society (ASES) Pain Score
时间窗: 10 Years Post-op
This is the patient's perception of pain related to the operative elbow. Maximum pain score = 50 (worst) Minimum pain score = 0 (best)
Patient Derived American Shoulder and Elbow Society (ASES) Function
时间窗: 10 Years Post-op
This is the patient's perception of function. The maximum score is 36 and the minimum score is 0. The maximum score represents maximum function.
Patient Derived American Shoulder and Elbow Society (ASES) Satisfaction
时间窗: 10 Years Post-op
This is the patient's perception of satisfaction with the elbow replacement surgery. Maximum Score = 10 Minimum Score = 0 Maximum Score represents maximum satisfaction.
次要结局
- Survivorship Will be Measured by the Incidence of Revision or Removals(10 years Post-op)