ACTRN12620000892910尚未招募未知
A randomised controlled trial comparing patient specific instrumentation (PSI)-kinematic alignment with PSI-mechanical alignment using a medial pivot design prosthesis to assess patient-reported functional outcomes
Whangarei Hospital0 个研究点目标入组 138 人开始时间: 2020年9月10日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 138
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 45 Years 至 o limit（—）
- 性别
- All
入选标准
- •Patients with end-stage osteoarthritis (Kellgren-Lawrence grade 3 or 4) deemed suitable for total knee arthroplasty and have exhausted non operative management
排除标准
- •Coronal > 15 degrees and sagittal deformity of >20 degrees
- •Mechanical lateral distal femur angle of 85-95 degrees and mechanical medial proximal tibia angles of 85-95 degrees
- •Patients who had previous open knee surgery that involved infection, osteotomy or fracture fixation
- •Patients with significant concomitant hip or spinal pathology making functional assessment of the knee replacement inaccurate
- •Contralateral knee pathology
- •Patients unable to complete or understand patient reported outcome assessment
- •BMI > 40kg/m2
- •History of previous knee infection
- •Patients with neurological disease or neurosensory deficiency
- •inflammatory arthritis
研究者
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