A Prospective Multi-Centre Study in Patients Undergoing Total Knee Replacement With JOURNEY II BCS and CR Total Knee System
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 9
- 主要终点
- Oxford Knee Score (OKS) at 2 years
研究概览
简要总结
Background:
The JOURNEY II BCS Total Knee System (JOURNEY II Bi-cruciate Stabilized Total Knee System) consists of femoral component made from oxidized zirconium (OXINIUM)
The JOURNEY II CR Total Knee System (JOURNEY II Cruciate Retaining Total Knee System ) consists of femoral component made from oxidized zirconium (OXINIUM)
Purpose:
Post-market evidence generation for JOURNEY II BCS and JOURNEY II CR Total Knee System
Objectives:
- Evaluate the performance of JOURNEY II TKA in Asia-Pacific (APAC) patient populations
- Establish the equivalent performance between JOURNEY II BCS and JOURNEY II CR to support adoption of JOURNEY II CR
Research participants / locations:
A total of at least 176 knees' information will be collected in up to 10 sites. There will be at least eighty-eight (88) knees for JOURNEY II CR TKA group and at least 88 knees for JOURNEY II BCS TKA group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with degenerative osteoarthritis.
- •Subject is planning to have bilateral Total Knee Arthroplasty (TKA) using JOURNEY II BCS & CR or have unilateral TKA using JOURNEY II BCS or JOURNEY II CR.*
- •Subject is able and willing to provide voluntary consent to study participation.
- •Subject is 18-80 years old (inclusive).
- •[* Bilateral cases can be simultaneous bilateral or staged bilateral (which an interval of 6-8 weeks apart between both knees)]
排除标准
- •Subjects with rheumatoid arthritis/inflammatory arthritis, posttraumatic arthritis.
- •Previous surgeries including High Tibial Osteotomy (HTO), Unicondylar Knee Arthroplasty (UKA) or Total Knee Arthroplasty (TKA) on the subject knee.
- •Subject is pregnant or breast feeding or those at a child-bearing age planning to become pregnant during the follow up.
- •Subject does not meet the indication or is contraindicated for JOURNEY II BCS & JOURNEY II CR's Instructions For Use (IFU).
结局指标
主要结局
Oxford Knee Score (OKS) at 2 years
时间窗: 2 years
The Oxford Knee Score (OKS) is a Patient Reported Outcome (PRO) questionnaire that was developed to specifically assess the patient's perspective of outcome following Total Knee Arthroplasty (TKA). The OKS is a patient self-completion PRO containing 12 equally weighted questions on activities of daily living. The OKS has been developed and validated specifically to assess perceived function and pain answered on a Likert scale after TKA. Responses to each question ranges from 0-4 with a range of a possible overall score from 0-48. A score of 0 is the worst possible outcome while a score of 48 is the best possible outcome.
次要结局
- Timed Up and Go Test (TUG)(Pre-Operative, Immediate Post -op to 6 weeks, 6 months, 1 year)
- Oxford Knee Score (OKS)(Pre-Operative, 6 months, 1 year, 3 years)
- Knee Society Score (KSS)(Pre-Operative, 6 months, 1 year, 2 years, 3 years)
- Patient Expectation(Pre-Operative)
- Radiographic Assessment(Pre-Operative, 6 months, 1 year, 2 years, 3 years)
- Forgotten Joint Score (FJS)(6 months, 1 year , 2 years, 3 years)
- Patient Satisfaction(6 months, 1 year, 2 years, 3 years)
- Star Excursion Balance Test (SEBT)(Pre-Operative, Immediate Post -op to 6 weeks, 6 months, 1 year)