NCT02633085撤回不适用
A Retrospective, Consecutive Series, Single Surgeon Study Comparing Patient Satisfaction and Clinical Outcomes in Patients With Fixed Bearing Versus Mobile Bearing Unicompartmental Knee Arthroplasty
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 compare patient satisfaction scores of the Unicompartmental Fixed Bearing (FB) UKA vs Unicompartmental Mobile Bearing (MB) UKA
研究概览
简要总结
The purpose of this study is to determine if there is a patient satisfaction preference of Fixed Bearing versus Mobile Bearing Unicompartmental Knee Arthroplasty (UKA) in patients who are at a minimum two years post operative. Patient reported outcomes and expectations will be analyzed along with all retrospective chart data in patient with a Fixed Bearing or a Mobile Bearing UKA in one or both knees.
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 a knee, single or multiple compartments,
- •Subjects must have undergone a FB UKA or MB UKA in one and or both knees. MB UKA or FB UKA patients revised to Total Knee Arthroplasty (TKA) are eligible to enroll.
- •Must be a minimum 2 year (24 months) post-surgery on the knee.
- •The UKA operation must have been performed by the 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 imaging studies.
排除标准
- •Subjects with Bicompartmental UKA (i.e. medical or lateral UKA combined with Patello Femoral Joint (PFJ) (UKA)
- •Women who are pregnant.
结局指标
主要结局
To compare patient satisfaction scores of the Unicompartmental Fixed Bearing (FB) UKA vs Unicompartmental Mobile Bearing (MB) UKA
时间窗: Minimum of two years post-surgery.
Utilizing Knee Score Society survey sub-score
次要结局
- Complications(Minimum of two years post-surgery.)
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(Minimum of two years post-surgery.)
- Forgotten Joint Score (FJS)(Minimum of two years post-surgery.)
- Euro-Qual Health related Quality of Life(Minimum of two years post-surgery.)
- Demographics(Minimum of two years post-surgery.)
- Return to Work History(Minimum of two years post-surgery.)
- Knee Society Score (KSS) subjective measures(Minimum of two years post-surgery.)
- Radiographic Analysis(Minimum of two years post-surgery.)
- Knee Society Score (KSS) Objective Measures(Minimum of two years post-surgery.)
研究者
研究点 (1)
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