Surgical Joint Registry
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 990
- 试验地点
- 1
- 主要终点
- Change of Knee Society Scores with KOOS survey
研究概览
简要总结
The purpose of this study is to follow the patient's short term and long term clinical outcome after undergoing joint replacement surgery.
详细描述
This is a registry database. Consented subjects will have their medical data collected via a patient questionnaire in either paper or web based application form. Data will be collected prospectively and retrospectively and will be entered into the database generated by Memorial Bone and Joint Research Foundation. Collection of data will start during the initial clinic visit as part of standard of care. Subjects will be asked to fill out a 4-page "pre-operative hip questionnaire" or "pre-operative knee questionnaire", which includes questions for self-assessment from the Hip Disability and Osteoarthritis Outcome Score (HOOS), Knee disability and Osteoarthritis Outcome Score (KOOS), EQ-5D and University of California, Los Angeles Activity (UCLA) questionnaires. Demographic, intra-operative and additional data will also be collected to correctly identify the subject's specific disease process and treatment plan. Subjects will be asked to fill out a post-operative hip and knee questionnaire that is similar to the pre-operative questionnaire to evaluate the improvement in their clinical outcomes. The subjects will be requested to complete the post-operative questionnaires at 6 months and annually thereafter.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria will be limited to subjects who have consented to undergo elective total joint replacement, hip resurfacing and partial knee surgery, arthroscopy and Femoro-actabular impingement (FAI) release performed by the PI.
- •All patients of legal adult age will be eligible for the study. All patients will have an equal chance to participate in the study regardless of race or gender. Patients will be enrolled in the order as they are diagnosed by the PI.
排除标准
- •Exclusion criteria will be limited to morbid obesity, active infection, heart failure, lung failure, severe bleeding abnormalities, subject with known metal allergy, subject who cannot legally decide for themselves.
结局指标
主要结局
Change of Knee Society Scores with KOOS survey
时间窗: Pre-operatively (baseline) and at 6 months, 12 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months, 120 months
The purpose of this study is to follow the patient's short term and long term clinical outcome after undergoing knee replacement surgery. These clinical outcomes will be assessed by using the KSS along with the KOOS survey for knee replacement cases. The scores obtained at each time point will be compared to the baseline. Therefore the outcome is the change of scores over time.
Change of Hip Society Scores with HOOS survey
时间窗: Pre-operatively (baseline) and at 6 months, 12 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months, 120 months
The purpose of this study is to follow the patient's short term and long term clinical outcome after undergoing hip replacement surgery. These clinical outcomes will be assessed by using the HSS for hips along with the HOOS survey for hip replacement cases. The scores obtained at each time point will be compared to the baseline. Therefore the outcome is the change of scores over time.
次要结局
未报告次要终点
研究者
Stefan Kreuzer MD
President
Memorial Bone and Joint Research Foundation