A Comparison of Two Total Hip Replacements: Hip Resurfacing System Versus Mallory-Head/Exeter
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Bone mineral density (BMD) in surrounding bone of the prosthesis
研究概览
简要总结
The purpose of this study is to compare two total hip replacement systems: Hip Resurfacing System (ReCap) versus Mallory-Head/Exeter.
详细描述
In Denmark approximately 7000 primary hip replacements are implanted yearly, and the incidence is rising with the increasingly aging population. For older patients, the incidence of later revisions of hip implantation is low. Unfortunately, this is not true for younger patients. Approximately 20% of patients under 55 years of age at the time of surgery must have the hip implant renewed within 10 years.
This is primarily because of the wear generated by polyethylene debris. The polyethylene is associated with osteolysis in the proximity of the prosthesis leading to failure of the prosthesis.
This unsatisfactory result has led to the development of an alternative hip prosthesis especially to benefit younger and physically active people. The new prosthesis should produce less inflammatory debris and less osteolysis induced failure.
To avoid the polyethylene particles, a new type of prosthesis has been made articulating metal on metal. The Hip Resurfacing System consists of an alloy of chrome - cobalt - molybdenum. Another point of interest for this prosthesis is also the size of the articulating surfaces which are bigger than usual. This will theoretically participate in the generation of metal ions.
Study objectives:
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
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with primary hip osteoarthrosis (OA).
- •Informed patient consent in writing.
- •Sufficient bone density to allow uncemented implantation of an acetabular component.
排除标准
- •Presence of other metal implants.
- •Working exposure of chrome, cobalt or molybdenum.
- •Ingestion of multivitamin or medication containing chrome, cobalt or molybdenum.
- •Kidney disease
- •Hip joint dysplasia
- •Patients with neuromuscular or vascular disease in the affected leg.
- •Patients who regularly take non-steroid anti-inflammatory drugs (NSAID) and cannot interrupt intake for the postoperative phase of the study.
- •Patients with fracture sequelae.
- •Female patients of childbearing capacity.
- •Sequelae to previous hip joint disorder in childhood
结局指标
主要结局
Bone mineral density (BMD) in surrounding bone of the prosthesis
时间窗: three years
Prostheses migration evaluated by radiostereometric analysis (RSA)
时间窗: three years
Proinflammatory- and bone degradation measures in blood samples
时间窗: three years
Metal ion release evaluated in urine
时间窗: three years
Gait pattern evaluated with 3D gait analysis, Vicon Polygon
时间窗: two years
次要结局
未报告次要终点