NCT02583113撤回不适用
A Retrospective Consecutive Series Patient Preference and Clinical Outcomes Study in Bilateral Knee Osteoarthritis Patients With Both Total Knee Arthroplasty and Unicompartment Knee Arthroplasty Prostheses.
Medacta USA1 个研究点 分布在 1 个国家开始时间: 2016年2月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- To evaluate patient preference of Total Knee Arthroplasty (TKA) vs Unicompartmental Knee Arthroplasty (UKA)
研究概览
简要总结
To determine if there is a patient satisfaction preference of Total Knee Arthroplasty (TKA) vs Unicompartmental Knee Arthroplasty (UKA) in patients with bilateral knee osteoarthritis who underwent a primary TKA one side and a primary UKA on the opposite side and are at a minimum of two years post-surgery. Patient reported outcomes and data with be analyzed along with all retrospective chart data.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Must be able to read, understand and provide written informed consent on the Institutional Review Board (IRB) approved Informed Consent Form (ICF)
- •Ability to understand and provide written authorization for use and disclosure of personal health information
- •Subject who are able and willing to comply with the study protocol and follow-up visit
- •Must be 18 years or older to participate
- •Subjects must have a clinically documented osteoarthritis in both knees, single or multiple compartments
- •Subjects must have undergone a primary TKA and primary UKA in the contralateral knee
- •Must be a minimum 2 year (24 months) post-surgery on each knee
- •One or both TKA/UKA surgeries must have been performed by the Principal Investigator.
- •Subjects must be able to return for the follow-up appointment, and have the mental capacity to cooperate with PRO's, questionnaires, physical exam and radiographs
排除标准
- •Subjects who underwent UKA with Patella Femoral Joint (PFJ) replacement on the same side.
- •Women who are pregnant
结局指标
主要结局
To evaluate patient preference of Total Knee Arthroplasty (TKA) vs Unicompartmental Knee Arthroplasty (UKA)
时间窗: Minimum 2 years post surgery
Asking patients "which is your better knee overall"
次要结局
- Forgotten Joint Score (FJS)(Minimum of 2 years post-op)
- Knee Society Score (KSS) subjective measures(Minimum of 2 years post-op)
- Euro-Qual Health Related Quality of Life (EQ-5D)(Minimum of 2 years post-op)
- Return to work history(Minimum of 2 years post-op)
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(Minimum 2 years post-op)
- Knee Society Score (KSS) Objective measures(Minimum of 2 years post-op)
- Radiographic Analysis(Pre-operative and minimum of 2 years post-op)
- Demographics(Pre-operative and Minimum of 2 years post-op)
研究者
研究点 (1)
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