Early Clinical Outcome of Medial Unicompartmental Knee Arthroplasty (UKA) and High Tibial Osteotomy (HTO) for the Treatment of Anteromedial Osteoarthritis (AMOA) in Chinese Population
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 370
- 试验地点
- 1
- 主要终点
- Oxford Knee Score
研究概览
简要总结
The purpose of this study is to compare the performance and safety of medial UKA and HTO in the treatment of AMOA in term of functional outcome, radiographic assessment, range of motion, postoperative complications, revision rate and relevant health economics outcome.
详细描述
The purpose of this study is to compare the outcomes of medial UKA and HTO in the treatment of AMOA by investigating the performance of these 2 procedures in terms of functional outcome, radiographic assessment, range of motion, postoperative complications, revision rate and relevant health economics outcome, then identify factors associated with better clinical performance. It is aimed to provide evidence-based guidelines for selecting the appropriate procedure in managing AMOA in Chinese population based on the findings of this study.
The secondary endpoints will include:
- Pain Numerical Rating Scale (NRS)
- SF-12 Health Survey
- Radiographic assessment includes pre-op and post-op mechanical femorotibial angle (mFTA), patella height, patellofemoral medial and lateral articular surfaces, and displacement angle of patella
- Range of motion
- Adverse event rate and classification (including complication)
- Operating time
- Total blood loss (BRECHER formula)
- Revision rate
Health economic outcomes based on hospital discharge days, recovery time, physiotherapy and complications/ reoperations will also be analyzed.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is aged 18 to 85 years old, inclusive;
- •Patients who diagnosed with AMOA of the knee, and have undergone Open Wedge HTO, or primary unilateral partial knee arthroplasty with Oxford Partial Knee with Microplasty® instrumentation in accordance to indications of UKA and the following radiographic assessments in the knee joint:
- •exposed bone on both the femur and tibia in the medial compartment.
- •functionally intact ACL
- •full thickness lateral cartilage (ignore osteophytes)
- •functionally normal MCL: correctable deformity (normal medial opening)
- •acceptable patellofemoral joint: normal, medial facet OA with or without bone loss, lateral facet OA without bone loss.
- •UKA or HTO procedure completed one year prior to study participation;
- •Patient provides written informed consent by signing and dating the Institutional Review Board/Ethics Committee (IRB/EC) approved informed consent form.
排除标准
- •Has undergone UKA but met any of the contraindications included in the product labeling of Oxford Partial Knee system;
- •Has rheumatoid arthritis or other forms of inflammatory joint disease;
- •Uncooperative or with neurologic disorders who are incapable of following directions;
- •Has a diagnosed systemic disease that could affect his/her safety or the study outcome;
- •Anterior cruciate ligament and posterior cruciate ligament injury, collateral ligament instability;
- •Known to be pregnant;
- •Prisoner or known alcohol / drug abuser.
结局指标
主要结局
Oxford Knee Score
时间窗: 2 years
Oxford Knee Score is a patient reported outcome measure questionnaire with a total score range from 0 (severe arthritis) to 48 (satisfactory joint function). The questionnaire contains 12 questions, each with five options scoring from 0 to 4 with 4 being the best outcome for each question.
次要结局
- Mechanical femorotibial angle (mFTA)(Pre-op, Post-op 1 month, 3 month, 6 month, 1 year and 2 year)
- SF-12 Health Survey(Pre-op, Post-op 1 month, 3 month, 6 month, 1 year and 2 year)
- Numerical Rating Scale (NRS)(Pre-op, Post-op 1 month, 3 month, 6 month, 1 year and 2 year)
- Range of motion(Pre-op, Post-op 1 month, 3 month, 6 month, 1 year and 2 year)
- Adverse event rate and classification(Intra-op, post-op 1 year and 2 year)