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Evaluation of Metal-on-conventional-polyethylene vs Ceramic-on-ceramic Articulating Surfaces in Total Hip Arthroplasty

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合作者:
信息的提供 (责任方):
Per-Erik Johanson,Sahlgrenska University Hospital, Sweden
August 20, 2018
October 2, 2018
October 2, 2018
October 2, 2003
December 31, 2022   (主要结果测量的最终数据收集日期)
Osteolysis frequency change between 7 and 15 years[ Time Frame: Change between 7 to 15 years after surgery ]
Osteolysis frequency (%) measured with computed tomography,

Osteolysis size change between 7 and 15 years[ Time Frame: Change between 7 and 15 years after surgery ]
Osteolysis size (cm3) measured with computed tomography

与当前相同
  • Articulation wear at 7 years[ Time Frame: At 7 years after surgery ]
    Articulation wear as measured with radiostereometry, mm/year
  • Articulation wear at 15 years[ Time Frame: 15 years after surgery ]
    Articulation wear as measured with radiostereometry, mm/year
  • Implant fixation at 7 years[ Time Frame: 7 years after surgery ]
    Stem and cup translation (mm/year) and rotation (degrees/year) measured with radiostereometry
  • Implant fixation at 15 years[ Time Frame: At 15 years after surgery ]
    Stem and cup translation (mm/year) and rotation (degrees/year) measured with radiostereometry
  • Clinical function at 7 years[ Time Frame: 7 years after surgery ]
    Harris Hip Score (0-100)
  • Clinical function at 15 years[ Time Frame: 15 years after surgery ]
    Harris Hip Score (0-100)
 
Evaluation of Metal-on-conventional-polyethylene vs Ceramic-on-ceramic Articulating Surfaces in Total Hip Arthroplasty
Randomized Evaluation of Metal-on-conventional-polyethylene vs Ceramic-on-ceramic Articulating Surfaces in Uncemented Total Hip Arthroplasty: A Radiostereometry Study Including 104 Patients

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.

Interventional
N/A
分配: Randomized
干预模型: Parallel Assignment
干预模型描述: Prospective randomized study
盲法: Interventional
盲法描述:
主要目的: Treatment
  • Device: Ceramic-on-ceramic uncemented hip arthroplasty
  • Device: Metal-on-polyethylene uncemented total hip arthroplasty
  • Active Comparator: 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).
  • Experimental: 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).
 
Active, not recruiting
104
与当前相同
December 31, 2022
December 31, 2022   (主要结果测量的最终数据收集日期)
Inclusion Criteria: - primary osteoarthritis - secondary osteoarthritis caused by idiopathic osteonecrosis, dysplasia or childhood disease (Mb Perthes, epiphysiolysis) Exclusion Criteria: - inflammatory arthritis - hip joint infection
参与研究的性别: All
最小年龄:35 Years ,最大年龄:64 Years  
没有
 
No
研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: Yes
计划分享 IPD: No
Per-Erik Johanson,Sahlgrenska University Hospital, Sweden
Sahlgrenska University Hospital, Sweden
:
Sahlgrenska University Hospital, Sweden
September 2018

ICMJE     国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素
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