Total Knee Arthroplasty Functional Outcomes Study Research Design
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Timed Functional Tests at 6 weeks
研究概览
简要总结
The purpose of this study is to obtain patient oriented and clinically oriented physical function outcomes both pre-operatively and post-operatively in patients receiving a total knee arthroplasty.
详细描述
This study aims to use up to 75 patients at 3 centers to determine a baseline short-term post-operative physical function status of patients undergoing a total knee arthroplasty through patient and clinically based assessments. The KOOS score will collect data on the patient's physical function, stiffness and pain. The BERG balance, TUG, and TUDS tests will be used quantitatively to assess the patient's ability to conduct activities of daily living like walking for an extended period of time, standing from a seated position, and maintaining balance while performing a series of actions.
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
- •Patient is male or non-pregnant female age 18 years or older at time of study
- •Patient is a candidate for a total knee arthroplasty
- •Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation
排除标准
- •Patients with a primary diagnosis other than osteoarthritis of the knee as determined by an orthopedic surgeon
- •Patients who have had any previous lower extremity procedure
- •Patients with a BMI greater than or equal to 40
- •Patients with an active infection within the affected knee joint
- •Patients with a neuromuscular or neurosensory deficiency that may limit the ability of the patient to evaluate the safety and efficacy of the device
- •Patients diagnosed with systemic disease or metabolic disorder leading to progressive bone deterioration (e.g. Lupus Erythematosus, Paget's disease)
- •Patients immunologically suppressed or receiving chronic steroids in excess of normal physiological requirements (e.g. greater than 30 days)
- •Patients with a known sensitivity to device materials
- •Non-English speaking patients
- •Patient is a prisoner
结局指标
主要结局
Timed Functional Tests at 6 weeks
时间窗: 6 weeks post-op
Assess patient functional outcomes over time. Comparing times from pre-op to post op of patients performing the same functional tests.
Timed Functional Testing at 1 year
时间窗: 1 year post-op
Assess patient functional outcomes over time. Comparing times from pre-op to post op of patients performing the same functional tests.
Timed Functional testing at 6 months
时间窗: 6 months post op
Assess patient functional outcomes over time. Comparing times from pre-op to post op of patients performing the same functional tests.
次要结局
- Outcome questionnaires at 6 months(6 months post-op)
- Outcome questionnaires at 6 weeks(6 weeks post-op)
- Outcome questionnaires at 1 year(1 year post op)