Aspects of Alignment, Function, and Migration Behaviour in Two Conceptually Different Articular Surface Designs in the Cruciate Retaining Version of the Cemented Persona Knee System - A Randomized Study Evaluated by RSA and CT Analysis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Region Skane
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Radiostereometry (RSA)
研究概览
简要总结
The aim of this study is to evaluate, over a 2 year period, the migration pattern, function and the possibility of anatomical reconstruction of a relatively new total knee arthroplasty (TKA) concept, the Persona. Sixty patients will be randomized into 2 groups of 30 patients each, with one group receiving the Persona TKA with a conventional Cruciate Retaining (CR) polyethylene articular surface and the other group with a newly developed Medial Congruent (MC) articular surface. Patients will be followed up with Radiostereometry (RSA), conventional radiography, outcome questionnaires, clinical evaluation and Computer Tomography (CT). The migration pattern of the components will be evaluated as well as the degree of anatomical reconstruction and clinical result.
We plan also to do a 5 year follow-up of the patients with RSA and PROMS.
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
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Osteoarthritis of the knee necessitating knee replacement
- •ASA I-III
- •BMI 18 - 35
排除标准
- •Joint sepsis in history
- •immunosuppresive drugs last 5 years
- •Rheumatoid arthritis
- •Severe osteoporosis or other metabolic bone diseases
- •Neuromuscular diseases
- •Personal disorders suspected of limiting rehab and completion of the trial period
- •Previous osteotomy of affected limb
- •Intra-articular knee fracture of affected limb
- •Peroperative fracture
- •Severe deformity of affected joint in need of augmentation or excessive release
- •Obvious need for more constrained knee than CR
研究组 & 干预措施
Cruciate Retaining Polyethylene (CR)
This is the standard Polyethylene articular surface
Medial Congruent Polyethylene (MC)
The intervention here will be the MC articular surface. This is the new Polyethylene articular surface with a more congruent medial side and a more flat lateral side which should better resemble natural anatomy.
干预措施: Medial Congruent Polyethylene (MC) (Device)
结局指标
主要结局
Radiostereometry (RSA)
时间窗: First postoperative day, 3 months, 1 year, 2 years and 5 years
Measure the change in component migration over time (translation and rotation around the x-, y- and z-axis)
次要结局
- Computer Tomography (CT)(Preoperatively and 3 months postoperatively)
- Conventional radiography(Preoperatively and 3 months postoperatively)
- General health questionnaire(Preoperatively, 1, 2 and 5 years postoperatively)
- Knee specific health questionnaire(Preoperatively, 1, 2 and 5 years postoperatively)