NCT05693818招募中不适用
A Multicenter, Single- Arm Study of Quantitative Assessment of Walking (Squawk) With the Canary canturioTM te (CTE) Tibial Extension
Canary Medical1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2023年1月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Limp Severity
研究概览
简要总结
The objective of this prospective study is to demonstrate accuracy of a limp detection model using a healthcare provider assessment as the non-reference standard.
详细描述
The primary endpoint of the study is limp severity at the 4-6 week office visit. At 4-6 weeks (+/- 3 days) post-surgery, the healthcare team will assess the patient's limp severity by visual observation on a 3-point Likert scale (0=No limp, 1=Mild/Moderate or 2=Severe).
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
- •• Patient must be 18 years of age or older
- •Independent of study participation, patient is indicated for a commercially available PIQ TKA implant in accordance with product labeling
- •Patient must be willing and able to complete the protocol required follow-up
- •Patient has participated in the study-related informed consent process
- •Patient is willing and able to provide written Informed Consent by signing and dating the IRB approved informed consent
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 with mental or neurologic conditions who are unwilling or incapable of following postoperative care instructions
- •Patient with Neuropathic Arthropathy
- •Patient with any loss of musculature or neuromuscular disease that compromises the affected limb
- •Patients with known symptomatic foot, hip or spinal injuries and/or conditions that could affect gait
结局指标
主要结局
Limp Severity
时间窗: 4-6 wks+3 days weeks post TKA
The primary endpoint of the study is limp severity at the 4-6 week office visit. At 4-6 weeks (+/- 3 days) post-surgery, the healthcare team will assess the patient's limp severity by visual observation on a 3-point Likert scale (0=No limp, 1=Mild/Moderate or 2=Severe).
次要结局
- Knee Range of Motion(4-6 wks+3 days weeks post TKA)
- Positive Percent Agreement (PPA) of the CMLM with the healthcare team's assessment(4-6 wks+3 days weeks post TKA)
- Limping Self Evaluation(4-6 wks+3 days weeks post TKA)
- Test-retest reliability of the Canary Medical Limping Model (CMLM) score(4-6 wks+3 days weeks post TKA)
- Negative Percent Agreement (NPA) of the CMLM with the healthcare team's assessment(4-6 wks+3 days weeks post TKA)
- Numeric Pain Rating Scale(4-6 wks+3 days weeks post TKA)
- KOOS Jr(4-6 wks+3 days weeks post TKA)
研究者
研究点 (1)
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