Tibial and Femoral Components Migration and Adaptive Bone Remodeling After Insertion of Persona® Total Knee Arthroplasty. A RCT Using RSA and DEXA Analysis for Evaluation of Uncemented With Trabecular Metal Surface vs. Cemented Fixation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Migration
研究概览
简要总结
The purpose of this study:
In a prospective randomized study with 2 years of follow-up we want to compare the migration of the uncemented trabecular metal (TM) versus the cemented tibial and femoral components of the new Persona® total knee arthroplasty (TKA) assessed by model based radiostereometric analysis (MB-RSA). Also, we want to compare the adaptive bone remodeling induced by the uncemented TM versus the cemented tibial and femoral components of the new Persona® TKA assessed by dual energy-X-ray (DEXA). Data generated for both above mentioned, will be also compared with historical RSA and DEXA data for the NexGen TKA using TM tibia modular and monoblock.
详细描述
Detailed Description: Main Hypothesis:
- The uncemented TM Zimmer Persona® TKA will have migration on the same level as the cemented Zimmer Persona® TKA.
- The uncemented TM Zimmer Persona® TKA will have less loss of BMD compared to the cemented version of the implant.
Material and Methods:
A prospective randomized study where the patients scheduled for TKA are randomized to receive tibial and femoral components with two different fixation modes:
Group A: an uncemented TM Zimmer Persona® TKA (uncemented tibia and femur components).
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
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Osteoarthrosis of the knee with indication for a TKA.
- •Age between 40 and 70 years.
排除标准
- •If a standard cruciate retaining implants cannot be used due to e.g. severe malalignment/deformity or instability.
- •Diseases affecting the bone metabolism (severe osteoporosis, Pagets disease, hyperparathyreoidism etc.).
- •Patients estimated not to be able to understand the "Information to patients" papers or do not want to participate in the study.
结局指标
主要结局
Migration
时间窗: 2 years
The differences between the cemented and uncemented implants are evaluated by measurements of migration of the stem assesed by Radiosteriometric analysis (RSA), measuring the migration by the MB-RSA Commercial software.
次要结局
- Adaptive bone remodelling(2 years)
研究者
Müjgan Yilmaz
Medical Doctor,Research Fellow
Rigshospitalet, Denmark