A Non-Randomized, Prospective Study of Short Term Outcomes Following Total Knee Replacement With JOURNEY™ II BCS Total Knee System Compared to Other Posterior Stabilized Total Knee Systems in a Physical Therapy Setting
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 22
- 试验地点
- 3
- 主要终点
- Difference in Knee Range of Motion (ROM) at the first outpatient Physical Therapy (PT) visit (≤7 days of surgery) between the 2 treatment groups
研究概览
简要总结
The primary objective of the study is to determine how the short-term outcome of subjects implanted with the JOURNEY™ II BCS Total Knee System compares to subjects implanted with other PS total knee systems, and to determine if there is a difference in health care resources consumed that may result in economic savings to patients, the facility and/or the payer.
To address the study objectives, patient self-assessment questionnaires, and other objective measures of post-operative function and health care resource utilization will be used for data collection.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergone unilateral primary total knee replacement with a JOURNEY™ II BCS Total Knee System or other Non-Smith & Nephew Posterior Stabilized Knee System
- •Will be initiating outpatient PT ≤ 7 days post-operatively
- •Has a primary diagnosis of osteoarthritis, degenerative arthritis, or traumatic arthritis
- •Has pre-operative ROM ≥ 90°
- •Is skeletally mature in the PI judgment
- •Is 21 years of age of older
- •Is willing and able to participate in required follow-up visits at the study site and to complete study procedures and questionnaires
- •Has consented to participate in the study by signing the IRB/EC approved informed consent for the study
- •Agrees to follow post- operative physical therapy program
排除标准
- •Significant preoperative varus or valgus deformities (>15º)
- •Has received a constrained or deep dish tibial insert
- •Morbid obesity (BMI > 40)
- •Has not obtained required pre-rehabilitation, pre-operative and intra-operative records by week 2 visit
- •Other comorbidities that may impact outcomes such as osteoporosis, uncontrolled diabetes and active infection
- •Fibromyalgia requiring treatment
- •Current or impending incarceration or is a prisoner
- •In the opinion of the PI has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse
- •Is known to be at risk for lost to follow-up, or failure to return for scheduled visits
- •Undergone or is planning to undergo total knee replacement of the contralateral knee within 6 months of this total knee replacement
- •Requires a Legally Authorized Representative to consent to the study
结局指标
主要结局
Difference in Knee Range of Motion (ROM) at the first outpatient Physical Therapy (PT) visit (≤7 days of surgery) between the 2 treatment groups
时间窗: ≤7 days of surgery
The absolute Range of Motion of index knee will be compared between groups
次要结局
未报告次要终点