Assessment of Clinical Outcome Following Total Hip and Knee Replacement
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Assessment of the patients' opinion about their knee. Score change over time
研究概览
简要总结
Patient-related outcomes were originally designed to measure outcomes in clinical studies. They were not developed to predict outcomes, however, different studies showed close association between values achieved preoperatively and postoperative outcomes. The aim of the present trial is to identify patients with satisfactory and unsatisfactory outcomes after joint replacement and to investigate whether there are any potential predicting potential in preoperative results of the patient-related outcomes and if there exist other predicting factors for functional recovery or treatment failure after joint replacement surgery.
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
- 否
入选标准
- •Patients with primary or secondary hip- and knee osteoarthritis undergoing joint replacement surgery.
排除标准
- •An inability to understand the Polish language,
- •Presence of neuromuscular disease and cognitive impairment,
- •Having a prosthesis in another joint of the ipsilateral or contralateral lower limb placed within 6 months before the current surgery,
- •Having rheumatoid arthritis,
- •Symptoms in several joints (hip, knee or ankle) with expected total joint arthroplasty within 1 year.
结局指标
主要结局
Assessment of the patients' opinion about their knee. Score change over time
时间窗: 12 months
Change between the following assessments as measured with the Knee injury and Osteoarthritis Outcome Score (KOOS) in patients undergoing total knee replacement; 0-100 points, worst to best; minimal clinical difference (MCD) = 10 points.
Assessment of the patients' opinion about their hip. Change over time
时间窗: 12 months
Change between the following assessments as measured with the Hip disability and Osteoarthritis Outcome Score (HOOS) in patients undergoing total hip replacement; 0-100 points, worst to best; minimal clinical difference (MCD) = 10 points.
次要结局
- Pain intensity. Change over time(12 months)
- Range of motion.(12 months)
- Assessment of the quality of life. Score change over time(12 months)
- Hip abductors muscle strength. Change over time(12 months)
研究者
Przemyslaw Paradowski
M.D., Ph.D.
Nicolaus Copernicus University