Randomized Control Trial of Four Bearing Surfaces in Primary Total Hip Arthroplasty in Patients Over the Age of 18 Years
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Wear rates of polyethylene over 10 years
研究概览
简要总结
The aim of the study is to assess the ideal bearing surfaces in hip replacement by comparing 4 different combinations. In a hip replacement this means what the head and the socket liner are made of.
详细描述
In hip replacements, arguably the most important thing for survivorship is what rubs against what.
Traditionally surgeons used metal (Cobalt-Chrome) against a conventional polyethylene (plastic). More recently (around 15 years ago) a newer more dense type of polyethylene (called XLPE) had been developed and a new type of head called Oxidized Zirconium was also developed.
In this trial, adults who were undergoing hip replacements were randomized assigned into one of the four groups:
Group 1: old plastic vs metal head Group 2: Old plastic against Oxidized Zirconium Group 3: New plastic versus metal head Group 4 New plastic vs Oxidized Zirconium
All patients were followed up for a minimum of 10 years to assess which group wore the most amount of polyethylene and which group had the best survival rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
The assessment of the implants was done by a secondary center that was unaware of which the bearing type was in which patient.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All adults with no history of cancer, infection of the hip and with the capacity to make informed consent for the trial
排除标准
- •those under the age of 18 and over
- •Those with a history of cancer and infection. Those without the capacity to make an informed consent.
研究组 & 干预措施
Conventional Polyethylene versus metal head
This is the more conventional group bearing surfaces
干预措施: Highly Cross Linked Polyethylene and oxidized zirconium femoral head (Device)
Conventional Polyethylene versus oxidized zirconium head
This group uses the more conventional polyethylene against the newer head
干预措施: Highly Cross Linked Polyethylene and oxidized zirconium femoral head (Device)
Newer Cross linked Polyethylene metal head
In this group we continued with the conventional polyethylene, but added in the new type of head (oxidized zirconium)
干预措施: Highly Cross Linked Polyethylene and oxidized zirconium femoral head (Device)
Newer Cross linked Polyethylene versus oxidized zirconium head
In this group, we added both the new head and the new polyethylene
干预措施: Highly Cross Linked Polyethylene and oxidized zirconium femoral head (Device)
结局指标
主要结局
Wear rates of polyethylene over 10 years
时间窗: Over 10 years of wear rates
Linear and volumetric wear were measured in the most recent radiographs using a computer software package (Polyware Rev. 5; Draftware).
次要结局
- Survivorship of implant combinations(over 10 years)