NCT02552095已完成不适用
A Prospective, Single Arm, Multi Center Study on the Compatibility of Triathlon PKR and the Motion Analysis for Japanese
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 10
- 主要终点
- Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
研究概览
简要总结
The Purpose of this study is to evaluate compatibility of the Triathlon Partial Knee Replacement (PKR) with the Japanese population. It is expected that patients who receive the Triathlon PKR will achieve excellent clinical results without adverse effects and that the device fits well with Japanese morphology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient requires a primary unicompartmental knee replacement.
- •Patient is between 20 years old to 80 years old.
- •Patient is diagnosed as osteoarthritis, rheumatoid arthritis, traumatic arthritis or avascular necrosis.
- •Patient can walk independently at least 10m.
- •Patient has signed the Institutional Review Board (IRB) approved, study specific informed patient consent form.
- •Patient is willing and able to comply with post-operative scheduled clinical and radiographic evaluations and rehabilitation.
排除标准
- •Patient requires a revision.
- •Patient is pregnant.
- •Patient has lateral osteoarthritis.
- •Patient has less than 10°of flexion contracture and greater than 90°of flexion.
- •Patient's preoperative mechanical alignment is less than 10° of varus and 15° of valgus.
- •Patient has had high tibial osteotomy, femoral osteotomy and/or joint fusion.
- •Patient has a neuromuscular or neurosensory deficiency that would limit the ability to assess the performance of the device.
- •Patient has a systemic or metabolic disorder leading to progressive bone deterioration.
- •Patient is immunologically suppressed or receiving steroids (>30 days) in excess of normal physiological requirements.
- •Patient has a deformity which will require the use of wedges or augments.
- •Patient has an active or suspected latent infection in or about the knee joint.
- •Patient who is inappropriate for participating in the study by the judgment of the investigator.
研究组 & 干预措施
Triathlon PKR
Other
Patient who receives the Triathlon.
干预措施: Triathlon PKR (Device)
结局指标
主要结局
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
时间窗: Pre-operation, 6 months, 12 months and 24 months after surgery
次要结局
- Change in Quality of life as assessed by 12-Item Short-Form Health Survey (SF-12) questionnaire(Pre-operation, 6 months, 12 months and 24 months after surgery)
- Measurement of tibial resection plane (A-P length and width of resection)(intraoperative)
- Change in Japanese Orthopaedics Association (JOA) score(Pre-operation, 6 months, 12 months and 24 months after surgery)
研究者
研究点 (10)
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