Anthology Hip Replacement System - Orthopaedic Data Evolution Panel (ODEP) Surveillance Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 270
- 试验地点
- 4
- 主要终点
- Quality of life with Oxford Hip Score (postal) - 10 years
研究概览
简要总结
This clinical study will verify the clinical and radiographic performance of the prosthesis when used in human subjects over a period of 10 years. All complications will be documented.
详细描述
The clinical evaluations will be based on standard, functional and pain parameters Harris Hip Score pre-operatively, and at 6 months, 3, 5, 7.5 and 10 years post-operatively. Postal Oxford questionnaire preoperatively, and yearly thereafter. The objective of this study is to analyse the clinical and radiographic responses and the complication rates for patients undergoing primary total hip arthroplasty using the Anthology Hip Replacement System (Anthology Hip System).
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Quality of life with Oxford Hip Score (postal) - 10 years
时间窗: 10 years post operative
Patients are asked to reflect on their pain and functional ability over the previous four weeks. There are two domains (pain and function) with six items or questions in each. Each item has five possible responses. In the original scoring responses were from 1 = least difficult to 5= most difficult. Item scores are summed to give a total score from anywhere between 12 and 60. The lower the score, the better the outcome.
Harris Hip Score - 10 years
时间窗: 10 years post operative
The Harris Hip Score is a joint specific score that consists of 10 items covering domains of pain (1 item, 0-44 points), function (7 items, 0-47 points), functional activities, absence of deformity (1 item, 0 or 4 points), and hip range of motion (2 items, 0-5 points). Scores range from 0 (worst) to 100 (best).
Quality of life with EuroQol Questionnaire (EQ-5D) -10 years
时间窗: 10 years post operative
The descriptive system consists of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which takes one of three responses. The responses record three levels of severity (no problems/some or moderate problems/extreme problems) within a particular dimension. The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. This information can be used as a quantitative measure of health outcome as judged by the individual respondents.
次要结局
- Quality of life with Oxford Hip Score (postal)(Pre-operative and 6 months, 3 years, 5 years, and 7.5 years post operative)
- Quality of life with EuroQol Questionnaire (EQ-5D)(Pre-operative and 6 months, 3 years, 5 years, and 7.5 years post operative)
- Device-related complications(6 months, 3 years, 5 years, 7.5 years, and 10 years post operative)
- Radiographic evaluations(Pre-operative, peri-operative, 6 months, 3 years, 5 years, 7.5 years, and 10 years post operative)
- Survival Rate(10 years post operative)
- Harris Hip Score(Pre-operative and 6 months, 3 years, 5 years, and 7.5 years post operative)
- Number of revisions or withdrawals for any reason(6 months, 3 years, 5 years, 7.5 years, and 10 years post operative)