A Multicenter, Single- Arm Postmarket Study of the Construct Validity of Community Walking Speed Data Collected Remotely With the Canary canturioTM te Tibial Extension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 6
- 主要终点
- 4 Meter Walk Test
研究概览
简要总结
The purpose of this study is to determine the construct validity of the Canary Tibial Extension's measure of self-selected community walking speed. Construct validity will be assessed by the Pearson's correlation coefficient between self-selected community walking speed and the 4-meter walk test. The objective of this multicenter, prospective study is to demonstrate that remote measurement of community walking speed with the Canary canturioTM (CTE) tibial extension is correlated with the fast 4-meter walk test (4mWT).
详细描述
The primary endpoint is community walking speed, calculated as a mean, remotely captured over the 7 days prior to the patient's regularly scheduled office visit: specifically, the correlation (Pearson correlation coefficient) of community walking speed with the 4mWT.
The secondary endpoints are as follows:
- Correlation coefficient between community walking speed and the Timed Up and Go (TUG) Test
- Completeness of data collection and transmission by the study device
- Correlation coefficient between community walking speed and the Oxford Knee Score
- Correlation coefficient between community walking speed and the Knee Injury and Osteoarthritis Outcome Score Jr (KOOS JR)
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 must be 18 years of age or older at the time of surgery
- •Patient is scheduled for or has undergone primary total knee arthroplasty using a Persona Personalized Knee System with Canary Tibial Extension (PIQ) TKA implant according to the appropriate surgical technique and IFU.
- •Patient must be willing and able to complete the protocol required follow-up
- •Patient has participated in the study-related informed consent process
- •Patient has a platform-compatible personal computer located in their dwelling with substantially reliable wireless internet access and a USB port
排除标准
- •Simultaneous bilateral TKA
- •Staged bilateral TKA less than 6 months from indexed procedure
- •Patient is a current alcohol or drug abuser
- •Patient is known to be pregnant, breastfeeding, or considered a member of a protected class (e.g., prisoner, mentally incompetent, etc.)
- •Patient has a psychiatric illness or cognitive deficit that will not allow proper informed consent and participation in follow-up program
- •Patient has previous history of infection in the affected joint and/or a local or systemic infection that may affect the prosthetic joint
- •Patient with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions
- •Patient with Neuropathic Arthropathy
- •Patient has rheumatoid arthritis accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin
- •Patient is undergoing procedures or treatments using ionizing radiation
- •Patient has a known or suspected sensitivity to one or more of the implant materials.
- •Patients with known orthopaedic lower extremity, spinal and/or neurologic conditions that could affect gait
结局指标
主要结局
4 Meter Walk Test
时间窗: 4 wks+2 weeks post TKA
A 4MWT test will be performed in the physician's clinic along a clear pathway of at least 8 in length in a designated area over solid flooring. The 8-m distance will be measured with a starting (0m) and an end point (8m) with additional marks at 2m and 6m to identify the 4m which is the timed portion of the test. A handheld, calibrated stopwatch will be used as the gold standard for measuring walking speed output during the 4 mWT, measuring the time it takes to complete the test.
Community Walking Speed
时间窗: 7 days prior to follow-up appoinment
Average walking speed
Timed Up and Go Test *(TUG)
时间窗: 4 wks+2 weeks post TKA
Patients may use a walking aid if needed. Patients will begin by sitting back in a standard armchair. Investigator will identify a line 3 meters (9.8 feet) away on the floor. When the investigator says "go" the patient will: 1. stand up from the chair 2. walk to the line on the floor at a comfortable and safe walking speed 3. turn and walk back to the chair at a comfortable and safe walking speed 4. Sit down again A stopwatch will be used to record the time it takes from the initiation of the exam on the word "go" to the end of the exam when the patient's buttocks touch the seat.
次要结局
- Oxford Knee Score(wks+2 weeks post TKA)
- KOOS Jr(4wks+2 weeks post TKA)
- Numeric Pain Rating Scale(wks+2 weeks post TKA)
- Clinical Limping Evaluation(4wks+2 weeks post TKA)