Long-term Outcomes of Complex Conversion Total Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- PROMIS SF v1.1-Pain Interference 8a
研究概览
简要总结
The purpose of the research study is to examine the long-term outcomes of complex and conversion total hip arthroplasty procedures. By means of both retrospective (chart review) and prospective (in-person clinic visits) radiographs and validated patient-reported outcome scores including the Hip Disability and Osteoarthritis Outcome Score (HOOS) and the Patient-Reported Outcomes Measurement Information System (PROMIS), the research team aims to collect, analyze, and summarize the outcome data. The outcomes of the follow-up appointment will be analyzed in comparison to previous findings over various intervals to assess changes over time, if data is available.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having undergone a conversion total hip arthroplasty (THA) more than five years ago or a complex THA more than ten years ago done by a UNC Health-affiliated physician
- •Willingness to receive follow-up care from a UNC Health-affiliated physician or provide outcome data regarding this surgical intervention
- •Able to speak and read English
- •Able to consent to participation
排除标准
- •Less than 18 years of age
- •Incarcerated status
结局指标
主要结局
PROMIS SF v1.1-Pain Interference 8a
时间窗: once during the 36-month total study duration, preferably during initial recruitment, but open to collection at any time during the study timeframe
The Patient-Reported Outcomes Measurement Information System (PROMIS) SF v1.1-Pain Interference 8a measures the amount of pain interference in daily life. Possible scores range from "not at all" (1) to "very much" (5), with higher scores indicating a worse outcome (more pain interference).
Radiographic Findings
时间窗: once during the 36-month total study duration, preferably during screening for initial recruitment, but open to collection at any time during the study timeframe
Standard radiographs of implanted hip to assess device efficacy and other potential anomalies. Collected during in-person clinic visits or from chart review if the patients have had hip radiographs at UNC in the past two years.
PROMIS SF v2.0 - Physical Function 20a
时间窗: once during the 36-month total study duration, preferably during initial recruitment, but open to collection at any time during the study timeframe
The Patient-Reported Outcomes Measurement Information System (PROMIS) SF v2.0 - Physical Function 20a measures the level of individual physical function in daily life. Possible scores range from "without any difficulty" (1) to "unable to do" (5) and "not at all" (1) to "cannot do" (5), with higher scores indicating a worse outcome (less physical function ability).
HOOS
时间窗: once during the 36-month total study duration, preferably during initial recruitment, but open to collection at any time during the study timeframe
The Hip Disability and Osteoarthritis Outcome Score (HOOS) measures an individual's feelings about their hip and how well they are able to do usual activities, based on symptoms, stiffness, pain, daily living function, sports and recreational activities function, and quality of life. Possible scores range from "never" (1) to "always" (5) and "none" (1) to "extreme" (5), with higher scores indicating a worse outcome.
次要结局
- Number of participants with comorbidities(Up to 36-months total study duration)
- Number of participants with complications(Up to 36 months total study duration)