A Multicenter Prospective Randomized Control Study on Persona Total Knee System vs NexGen Total Knee System in Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 332
- 试验地点
- 9
- 主要终点
- Oxford Knee Score
研究概览
简要总结
A multicenter, prospective randomized controlled trial comparing the Persona knee system to the Nexgen knee system in total knee arthroplasty.
详细描述
Knee replacement is an established treatment for late stage osteoarthritis (OA) of the knee. There is an increasing demand for joint replacement in a younger population. Due to the changing demographics of joint replacement, the population of younger patients are seeking options that not only correct their disease or deformity, but do not limit them in activity. Studies have shown that modern implant designs can potentially improve outcome. Therefore new implants are introduced to the marked with the theoretical benefit of improved implant survival and superior patient reported outcomes. Within Total knee arthroplasty, design changes are introduced in an attempt to improve knee kinematics, functionality and outcome, but those potential improvements need to be evaluated.
The NexGen Total Knee System is a knee replacement system with well a documented performance and has been the device of choice in many institutions. Recently, Zimmer-Biomet have introduced Persona Total Knee system with design changes that include asymmetric tibia plate, increased medial pivoting and more extensive choices in respect to poly thickness, all with the purpose to improve balancing, stability and longevity. Such design changes and proposed benefits need to be evaluated in a prospective clinical trial, with focus on patient safety, satisfaction and implant durability.
The aim is to evaluate intra-operative and postop complications, long-term survivorship and patient reported outcome measures following primary total knee replacement using Persona Cruciate Retaining (CR) total Knee system compared to NexGen Cruciate Retaining (CR) total Knee System.
This project is carried out as a 2-arm randomized controlled single-blinded trial. A total of 314 participants are to be included at 6 centers in Denmark. Participants are seen on an outpatient basis at 3 months and 1 and 2 years postoperatively. After 2-year follow-up the patients will be followed for survivorship through the Danish Knee Arthroplasty Registry.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical and radiological osteoarthritis of the knee set to receive a primary unilateral total knee replacement
- •>18 years of age
- •Participants must be able to speak and understand Danish
- •Participants must be able to give informed consent and be cognitively intact
- •Participants must be able to complete all post-operative controls
- •Participants must not have severe comorbidities, American Society of Anesthesiologists (ASA) score ≤ 3
- •Clinically suitable to receive a CR implant (no severe deformity and/or ligament instability)
排除标准
- •Terminal illness
- •Revision knee replacement surgery
- •Rheumatoid Arthritis (RA)
- •Traumatic etiology
- •Prior surgery on the affected knee that includes osteosynthesis, Anterior cruciate ligament (ACL) and/or Posterior cruciate ligament (PCL) and/or collateral ligament surgery. Arthroscopy with meniscectomy / cartilage surgery / house cleaning is allowed.
- •Altered pain perception and / or neurologic affection due to diabetes or other disorders.
- •Patients will be excluded intraoperative if CR implant is not suitable.
研究组 & 干预措施
Persona CR
Patients who received a Persona CR total knee implant
干预措施: Persona total knee system (Device)
NexGen CR
Patients who received a NexGen CR total knee implant
干预措施: Nexgen total knee system (Device)
结局指标
主要结局
Oxford Knee Score
时间窗: 3 months, 1 year and 2 years postoperatively
The OKS is a patient-reported outcome questionnaire that was developed to specifically assess the patient's perspective of outcome following TKA. The OKS consists of twelve questions covering function and pain associated with the knee. To calculate the total score, each question is scored from 0 (worst outcome) to 4 (best outcome) and the sum of all 12 items is reported with a maximum of 48, representing the best score possible. The outcome score can be categorized as Excellent: \> 41; Good: 34 - 41; Fair: 27 - 33; Poor: \< 27
次要结局
- Oxford Knee Score - Activity & Participation Questionnaire (APQ)(3 months, 1 year and 2 years postoperatively)
- Forgotten Joint Score (FJS)(3 months, 1 year and 2 years postoperatively)
- Patient Satisfaction and Anchoring Questions - Question 1(3 months, 1 year and 2 years postoperatively)
- Patient Satisfaction and Anchoring Questions - Question 2(3 months, 1 year and 2 years postoperatively)
- Patient Satisfaction and Anchoring Questions - Question 3(3 months, 1 year and 2 years postoperatively)
- Patient Satisfaction and Anchoring Questions - Question 4(3 months, 1 year and 2 years postoperatively)
- EuroQol 5D (EQ-5D) Score(3 months, 1 year and 2 years postoperatively)
- Radiolucency / Osteolysis(Immediate postoperative and 3 months, 1 year and 2 years postoperatively)
- Long-term Survivorship(5, 7 and 10 years postoperatively.)