What Determines Satisfaction of Patients With Rheumatoid Arthritis After Hand Reconstruction Using Silicone Metacarpophalangeal Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Satisfaction with the treatment result assessed on a 5-point Likert Scale
研究概览
简要总结
The primary objective of this study is to identify determinants of long-term patient satisfaction after hand reconstruction using silicone metacarpophalangeal arthroplasty (SMPA). The investigators hypothesize that appearance of the hand, ulnar drift, range of motion, pain, hand function and intake of the newer antirheumatic drugs (i.e. biologicals) influence patient satisfaction.
详细描述
This is an ambidirectional, monocenter research project consisting of a retrospective chart review and a prospective cohort project.
Participants fulfilling all of the following inclusion criteria are eligible for the project:
- Patients with rheumatoid Arthritis (RA) / Psoriasisarthritis / Lupus erythomatodes who had a SMPA between Jan 2007 and one year before the project examination
- Informed Consent as documented by signature
The presence of any one of the following exclusion criteria will lead to exclusion of the participant:
- Major surgery at another joint at the hand (e.g. proximal interphalangeal (PIP) joint arthroplasty, thumb trapeziectomy) less than 6 months ago
- Legal incompetence
- German language barrier to complete the questionnaires
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with RA / Psoriasisarthritis / Lupus erythomatodes who had a SMPA between Jan 2007 and one year before the project examination
- •Informed Consent as documented by signature
排除标准
- •Major surgery at another joint at the hand (e.g. PIP arthroplasty, thumb trapeziectomy) less than 6 months ago
- •Legal incompetence
- •German language barrier to complete the questionnaires
结局指标
主要结局
Satisfaction with the treatment result assessed on a 5-point Likert Scale
时间窗: at least one year after surgery
The primary outcome is the satisfaction with the treatment result at least one year after surgery and its determinants. It will be quantified using this question: How satisfied are you with the overall result of the SMPA surgery? The response options are: Very satisfied (score 1), somewhat satisfied (score 2), neither satisfied nor unsatisfied (score 3), somewhat unsatisfied (score 4), very unsatisfied (score 5). For further analyses, this question can be dichotomized into the categories of "satisfied patients" (very satisfied / satisfied) and "unsatisfied patients" (neither satisfied nor dissatisfied or worse).
次要结局
未报告次要终点