A Prospective Total Joint Surgery Registry to Monitor Short- and Long-Term Clinical Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Knee Society Score
研究概览
简要总结
The investigators propose a prospective longitudinal registry study to collect and compare preoperative and postoperative information from patients who undergo total joint arthroplasty (TJA). Outcomes will be assessed with common, routinely available patient-reported outcomes measures (PROM's) such as the HOOS Jr., Oxford score, Knee Society Score, Harris Hip Score, and other patient satisfaction and function assessments in use in Orthopedics.
详细描述
The investigators propose a prospective longitudinal registry study to collect and compare preoperative and postoperative information from patients who undergo total joint arthroplasty (TJA). Outcomes will be assessed with common, routinely available patient-reported outcomes measures (PROM's) such as the HOOS Jr., Oxford score, Knee Society Score, Harris Hip Score, and other patient satisfaction and function assessments in use in Orthopedics. Investigators will also record both demographic and clinical data about the subject's history of joint pain, past treatment, medical co-morbidities, and surgical procedure.
Additionally, gait analysis and standardized physical capacity testing will be included as an option. All patients undergoing hip or knee replacement with the primary investigator will be included for data collection. All procedures and treatment will follow the standard of care, and all prosthetic implants with be FDA-approved. Data will be used to evaluate the effect on both short and long-term comfort and function of patients diagnosed with hip or knee pain who undergo joint replacement. The main purpose of the study is to provide quality improvement data on the patients in the Principal Investigator's (PI's) practice currently undergoing joint surgery. This project creates a data repository to store participants' data for this and possible future research.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are scheduled to undergo TJA by the Principal Investigator
排除标准
- •Age < 18
- •Unable to speak and read English
- •Prisoners or any other patients who, in the opinion of the investigator, are unlikely to return for follow-ups or unreliable in completing the assessments
结局指标
主要结局
Knee Society Score
时间窗: Pre-op, 6 weeks, 6 months, 1 year, 2 years, and 5 years
The Knee Society Score (KSS) provides a 0 to 100 score measuring function, pain, and range of motion in the knee before and after surgery. A score of 0 indicates the worst outcome, while a score of 100 indicates the best outcome.
Forgotten Joint Score
时间窗: Pre-op, 6 weeks, 6 months, 1 year, 2 years, and 5 years
The Forgotten Joint Score assesses how aware the patient is of their joint in everyday life. A score of 0 is the worst (always aware) while a score of 100 is the best (the patient is so comfortable, they forget that the joint was replaced).
Joint Awareness Survey
时间窗: Pre-op, 6 weeks, 6 months, 1 year, 2 years, and 5 years
The Joint Awareness Survey is an abbreviated version of the Forgotten Joint Score. It also has 0 as the worst outcome and 100 as the best. We are including it to determine if it can reliably be used in place of the Forgotten Joint Score, which is longer and more burdensome for patients to fill out.
Pain Satisfaction Expectations
时间窗: Pre-op, 6 weeks, 6 months, 1 year, 2 years, and 5 years
This survey assesses patients' satisfaction with their joint, their pain level, their overall function, and their need for pain medication. 0 is the worst score while 100 is the best.
PROMIS Global Health
时间窗: Pre-op, 6 weeks, 6 months, 1 year, 2 years, and 5 years
This survey assesses the general health and quality of life of the patient. It is also a 0-100 point scale with 100 being best, 0 being worst, and 50 being average. Every 10 points represents one standard deviation from the mean.
Koos Jr. Knee Survey
时间窗: Pre-op, 6 weeks, 6 months, 1 year, 2 years, and 5 years
This survey assesses stiffness, pain, and function of the knee. 0 is the worst score and 100 is the best.
Harris Hip
时间窗: Pre-op, 6 weeks, 6 months, 1 year, 2 years, and 5 years
This survey assesses pain, deformity, and range of motion of the hip. A score of 0 indicates the worst outcome and 100 indicates the best.
Hoos Jr.
时间窗: Pre-op, 6 weeks, 6 months, 1 year, 2 years, and 5 years
This survey assesses pain and function of the hip in daily life. A score of 0 indicates the worst outcome, while a score of 100 indicates the best.
次要结局
未报告次要终点
研究者
David F. Scott, MD
MD
Spokane Joint Replacement Center