5 Year Clinical and Radiographic Follow-up of the Uncemented Symax Hip Stem in an International Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 主要终点
- Change of Harris Hip Score (HHS) during follow-up
研究概览
简要总结
The uncemented Symax hip stem is developed through optimization of the uncemented Omnifit hip stem. The Symax stem design combines an anatomical anteverted proximal geometry with a straight distal section. The proximal part is coated with a biomimetic hydroxyapatite (HA) coating for improved osseointegration to enhance load transfer and to minimize proximal bone loss. The distal part is treated with an anodization surface treatment in order to prevent distal bone apposition, which is expected to prevent distal loading and reduce proximal stress shielding. Aim of this study is to report mid-term clinical performance and evaluate whether the radiographic features are in line with the design principles of the Symax hip in an international clinical study with 5 years of follow-up.
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
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients requiring uncemented primary total hip arthroplasty (osteoarthritis, avascular necrosis and/or post-traumatic arthritis), age between 18-70 years, BMI less or equal to 35.
排除标准
- •Patients with bilateral hip complaints, impaired cognitive function and use of medication or illness influencing bone metabolism.
研究组 & 干预措施
Symax uncemented hip stem
The Symax hip stem is an uncemented design forged from Ti6Al4V alloy (Stryker EMEA). Primary mechanical stability is provided by anatomical metaphyseal geometry. The hip stem features a size dependent anteversion, neck length and offset, with a CCD angle of 128°. Secondary biological stability is accomplished by fast osseous integration due to the BONIT-HA coating on the metaphyseal part of the stem.
干预措施: Symax uncemented hip stem (Device)
结局指标
主要结局
Change of Harris Hip Score (HHS) during follow-up
时间窗: Preoperative HHS and postoperatively change in HHS at 6 months, 1 year, 2 years, 3 years and 5 years
A hip specific functional score
次要结局
- Radiographic evaluations(Immediately postoperative radiograhpic evaluation as baseline and changes in radiography at follow-up 6 months, 1 year, 2 years, 3 years and 5 years we evaluated the radiograhip evaluations again)