A Comparison of Two Metal Surface Finishes (Proximal-Coated Titanium Surface Versus Mid-Coated Titanium Surface) on Femoral Components in Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- migration of femoral components evaluated by RSA
研究概览
简要总结
The purpose of this study is to compare metal surface finishes (proximal-coated titanium surface versus mid-coated titanium surface) on femoral components in hip arthroplasty.
详细描述
In younger patients femoral components are most often implanted without the use of cement. A direct ingrowth of bone to the implant is crucial to the attainment of good results in those cases where cement is not employed.
The construction of a femoral implant, Versys Fiber Metal Taper®, by Zimmer includes a more extensive coating than previous femoral implants. The improved surface coating has been shown to provide these implants with better properties than those demonstrated by implants currently in general use.
Theoretically, the greater porous surface of mid-coated implants should:
- Encourage bone ingrowth through improved osteoconductive properties, however more extensive coating might change the loss of bone due to stress shielding later in time
- Improve anchorage of the implant due to the higher friction coefficient
- Result in fewer postoperative complaints measured with the Harris Hip Score and visual analog scale scores
The migration of femoral components will be evaluated by RSA, performing radiostereometric analyses at the Orthopaedic Center, Aarhus University Hospital. The follow-up RSA will be scheduled for week 1, as well as 3 months, 12 months and 2 years after surgery. Bone mineral density around the implanted femoral component will be examined by DEXA scan at week 1, as well as 1 year and 2 years after surgery.
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
- Double
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with primary arthritis in the hip.
- •Patients with sufficient bone density to allow uncemented implantation of a femoral component.
- •Informed patient consent in writing.
排除标准
- •Patients with neuromuscular or vascular disease in the affected leg.
- •Patients found upon operation to be unsuited for uncemented acetabulum component.
- •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.
- •Hip joint dysplasia.
- •Sequelae to previous hip joint disorder in childhood.
结局指标
主要结局
migration of femoral components evaluated by RSA
次要结局
- BMD in the surrounding bone tissue of femoral components