Improving Orthopedic Outcomes Through a National TJR Registry
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30,000
- 试验地点
- 1
- 主要终点
- Unadjusted and risk-adjusted patient reported physical function composite score, measured by the Short Form 36 (SF 36) Physical Component sub-score
研究概览
简要总结
Aim 1. Establish a national registry of diverse patients of orthopedic surgeons representing all regions of the country and varied hospital and surgeon practice settings (e.g., urban/rural, low and high volume) to ensure that registry analyses and research reflect typical clinical practice thereby providing optimal guidance for patients, clinicians, and national healthcare policymakers. Collect pre-operative and post-operative patient reported outcomes (PROs) for pain and function.
Aim 2: Develop new and transformative comparative effectiveness tools useful to both clinical practice and healthcare policy.
Aim 3. Broadly disseminate surveillance reports for adverse events, such as implant revision, hip dislocation, knee manipulation, and identify important variation to inform quality improvement priorities.
详细描述
Patients scheduling elective total joint replacement surgery are eligible to participate.
The Aims of the registry are as follows:
Aim 1. Establish a national registry of diverse patients of orthopedic surgeons representing all regions of the country and varied hospital and surgeon practice settings (e.g., urban/rural, low and high volume) to ensure that registry analyses and research reflect typical clinical practice thereby providing optimal guidance for patients, clinicians, and national healthcare policymakers. Collect pre-operative and post-operative patient reported outcomes (PROs) for pain and function.
Pre-surgery data. Patients will complete a set of computer-based clinical and behavioral health questions prior to surgery. A paper option is available as well. Data collected include demographics, medical and musculoskeletal comorbidities, pain and function measures.
6 month survey. Patients will receive an invitation to complete the 6 month survey either on the computer at home or on paper. This survey includes the symptom assessment and a screening survey for complications.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be scheduled elective primary or revision arthroplasty
- •Must speak/read English or Spanish
排除标准
- •Arthroplasty is scheduled due to fracture or malignancy
- •Inability to provide informed consent due to dementia or cognitive impairment
- •Terminal illness with life expectancy of less than 1 year
- •Emergently scheduled surgery.
- •Individuals who are under 18 years of age
- •Pregnant women
- •Prisoners
结局指标
主要结局
Unadjusted and risk-adjusted patient reported physical function composite score, measured by the Short Form 36 (SF 36) Physical Component sub-score
时间窗: Up to 3 months prior to elective TJR surgery
Collection of patient reported physical function composite score from the SF 36 Physical Component sub-score measure
Change in unadjusted and risk-adjusted patient reported pain composite score, measured by the HOOS/KOOS pain score
时间窗: 20 years post elective TJR
Collection of patient reported pain composite score from the HOOS/KOOS measure
Change in unadjusted and risk-adjusted patient reported physical function composite score, measured by the SF 36 Physical Component sub-score
时间窗: 20 years post elective TJR
Collection of patient reported physical function composite score from the SF 36 Physical Component sub-score measure
Unadjusted and risk-adjusted patient reported pain composite score, measured by the Hip disability and Osteoarthritis Outcome Score/Knee disability and Osteoarthritis Outcome Score (HOOS/KOOS) pain score
时间窗: Up to 3 months prior to elective TJR surgery
Collection of patient reported pain composite score from the HOOS/KOOS measure
次要结局
- Surveillance reports for adverse events, such as implant revision, hip dislocation, knee manipulation and other adverse events.(6 months post elective TJR)
研究者
David Ayers
Principal Investigator
University of Massachusetts, Worcester