Cementless New Alumina-zirconia(4th Generation Ceramic Bearing) Composite Ceramic Bearing Total Hip Arthroplasty (THA) in Asian Patients : a 10 Year Minimum Follow-up Study
试验速览
- 阶段
- 不适用
- 入组人数
- 310
- 试验地点
- 2
- 主要终点
- Survival rate of THA with use of the new alumina-zirconia(4th generation ceramic bearing) composite ceramic bearing at a minimum of 10 years follow-up.
研究概览
简要总结
This study will evaluate a midterm clinical and radiologic outcome patients who undergo new alumina-zirconia composite ceramic bearing THA.
详细描述
Total hip arthroplasty (THA) using a metal-on-polyethylene articulation has become one of the most effective procedures for the surgical treatment for end-stage hip disease.
However, polyethylene wear debris-induced osteolysis has been postulated to cause/contribute to the aseptic loosening of a THA, and hence, is regarded to be an important factor in its in vivo longevity.
In the third generation of ceramic manufacturing, many improvements, such as hot isostatic pressing, laser marking, and non destructive proof-testing for all ceramic components, have been introduced. This third generation ceramic component has high purity, high density, and small grain size, and, therefore, has a very high potential for resisting crack propagation, which may culminate in its fracture. In spite of this, a number of substantial concerns, such as ceramic fracture, impingement-associated fatigue failure, wear, and osteolysis after long-term follow-up, persist with the use of ceramics in THA.
In addition, the third generation ceramic articulation is associated with an increased incidence of dislocation because ceramic liners with elevated rim and extended-long-neck ceramic heads are not available.
However, new alumina-zirconia composites bearing implants (4th generation ceramic bearing) affords various options such as large head and thin liner, which may decrease the ceramic fracture rate and dislocation rate and improve the longevity of THA. In addition, large head can improve the range of motion and possible traditional cross-legged sitting position of Koreans without impingement between the neck and liner rim.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have femoral head osteonecrosis
- •Subjects who have primary or secondary osteoarthritis
- •Subjects who have femoral neck fracture
- •Subjects who have infection sequels
- •Subjects who have rheumatoid arthritis or ankylosing spondylitis
- •Subjects who have developmental dysplasia of the hip or acetabular dysplasia
排除标准
- •Subjects who have active infection
- •Subjects who have unstable medical illness
- •Subjects who have rapidly progressive neurological disease
- •Subjects who have revision surgery or bipolar endoprosthesis
结局指标
主要结局
Survival rate of THA with use of the new alumina-zirconia(4th generation ceramic bearing) composite ceramic bearing at a minimum of 10 years follow-up.
时间窗: up to 10 years
次要结局
- Evaluation between preoperative and postoperative of Harris hip score, UCLA activity score, WOMAC, and Subject satisfaction score at a minimum of 5 years follow-up.(Follow-up evaluations will be performed at six weeks; at three, six, nine, and twelve months and every 12 months thereafter.)
- The performance in patients younger than 50 years at 10 years follow up(Follow-up evaluations will be performed at six weeks; at three, six, nine, and twelve months and every 12 months thereafter.)
研究者
Kyung-Hoi Koo
Professor
Seoul National University Bundang Hospital