Randomized Evaluation of Metal-on-conventional-polyethylene vs Ceramic-on-ceramic Articulating Surfaces in Uncemented Total Hip Arthroplasty: A Radiostereometry Study Including 104 Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 104
- 主要终点
- Osteolysis frequency change between 7 and 15 years
研究概览
简要总结
Polyethylene wear debris from metal-on-polyethylene articulations are one of the main causes of periprosthetic bone loss and non-infectious loosening in total hip arthroplasty. Ceramic articulations have a very low wear rate when measured in the laboratory and the investigator's hypothesis is that hip arthroplasty with an all ceramic articulation will have less osteolysis and wear in addition to equally good fixation and clinical outcome compared to the same hip arthroplasty design with a metal-on-polyethylene joint.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary osteoarthritis
- •secondary osteoarthritis caused by idiopathic osteonecrosis, dysplasia or childhood disease (Mb Perthes, epiphysiolysis)
排除标准
- •inflammatory arthritis
- •hip joint infection
研究组 & 干预措施
Metal-on-conventional polyethylene
Uncemented hip arthroplasty (ABG-2, Stryker, Mahwah NJ, US) with a CoCr prosthetic femoral head and an acetabular liner made of intermedially cross-linked polyethylene polyethylene (Duration, Stryker, Mahwah, NJ, US).
干预措施: Metal-on-polyethylene uncemented total hip arthroplasty (Device)
Ceramic-on-ceramic
Uncemented hip arthroplasty (ABG-2, Stryker, Mahwah NJ, US) with a prosthetic femoral head and an acetabular liner made of alumina ceramic (Biolox Forte, Ceramtec, Plochingen, Germany).
干预措施: Ceramic-on-ceramic uncemented hip arthroplasty (Device)
结局指标
主要结局
Osteolysis frequency change between 7 and 15 years
时间窗: Change between 7 to 15 years after surgery
Osteolysis frequency (%) measured with computed tomography,
Osteolysis size change between 7 and 15 years
时间窗: Change between 7 and 15 years after surgery
Osteolysis size (cm3) measured with computed tomography
次要结局
- Clinical function at 7 years(7 years after surgery)
- Articulation wear at 7 years(At 7 years after surgery)
- Articulation wear at 15 years(15 years after surgery)
- Implant fixation at 7 years(7 years after surgery)
- Implant fixation at 15 years(At 15 years after surgery)
- Clinical function at 15 years(15 years after surgery)
研究者
Per-Erik Johanson
Researcher
Sahlgrenska University Hospital, Sweden