Scorpio PS vs Scorpio NRG PS - Total Knee Arthroplasty Comparative Investigation of Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Comparison of Maximum Passive and Active Flexion.
研究概览
简要总结
Single-centre, prospective, randomized comparative study to compare the maximum flexion and Chair Raise achievement ratios of the Scorpio PS and and the Scorpio NRG PS. Documentation of all complications.
详细描述
Surveillance design: Single-centre, prospective, randomized comparative study. Objectives: To compare the maximum flexion (active and passive) and Chair Raise achievement ratios. All complications will be documented.
Number of subjects to be enrolled: All consecutive Scorpio patients are included until a group size of 88 is reached.
Clinical evaluations: Chair raise test, Stair climb test, Western Ontario McMaster Osteoarthritis Index (WOMAC) patient self evaluation, EuroQuol - 5 dimension (EQ-5D) patient questionnaire. Standard clinical, functional and pain parameters (Knee Society Score), pre-operatively and post-operatively. All per- and post-op complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Patients requiring a primary total knee arthroplasty (TKA)
- •Male and nonpregnant female patients
- •Between 18 and 80 years of age at time of surgery
- •Patients with a diagnosis of osteoarthritis (OA), avascular necrosis (AVN), and not severe posttraumatic arthritis
- •No previous osteosynthesis of the involved knee during the last 12 months
- •Patients who understand the conditions of the study and are wiling to participate for the length of the described follow up
- •Patients who are capable of, and have given, informed consent for participation in the study
排除标准
- •Patients requiring revision surgery of a previous implanted total knee system
- •Patients with a diagnosis of severe posttraumatic arthritis (TA) and rheumatoid arthritis (RA)
- •Patients with active infection
- •Patients with malignancy
- •Patients with an immobile hip or ankle arthrodesis
- •Severe obese patients (BMI > 35)
- •Patients with a neurological deficit
- •Previous history of unicompartmental knee arthroplasty or patellar prosthesis
- •Patients with concurrent illnesses which are likely to affect their outcome
结局指标
主要结局
Comparison of Maximum Passive and Active Flexion.
时间窗: 5 years follow-up
Comparison of maximum flexion, both passive and active between Scorpio NRG PS knee prosthesis and the Scorpio PS knee prosthesis. The active flexion-tolerated range is greater/equal 70 degree. The passive flexion-tolerated range is greater/equal 80 degree. The Hyperextension tolerated range is 0 to 10 degree. Higher scores mean a better outcome.
次要结局
- WOMAC Patient Questionnaire(pre-operative, 12, 26 weeks and 1, 2 and 5 years follow-up)
- Knee Society Score (KSS)(pre-operative, 6, 12, 26 weeks and 1, 2 and 5 years follow-up)
- Chair Raise Test(pre-operative, 6, 12, 26 weeks and 1, 2 and 5 years follow-up)
- EQ-5D (Euro-Quol 5-Dimension) Patient Questionnaire(pre-operative, 12, 26 weeks and 1, 2 and 5 years follow-up)