A Retro/Prospective Multi-Centre Data Capture on REDAPT Sleeved Stem
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Harris HIp Score (HHS)
研究概览
简要总结
Retro/Prospective study to collect 2 year follow-up on REDAPT sleeved stem.
详细描述
The purpose of this study is to assess performance and safety of the Smith & Nephew REDAPT Sleeved Stem by collecting retrospective 2 year post-op with PROMs or prospective 2 year post-op with PROMs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Primary and revision surgery for hip degenerative joint disease including osteoarthritis, avascular necrosis, and traumatic arthritis.
- •Rheumatoid arthritis, congenital dysplasia, femoral neck fracture, trochanteric fractures of the proximal femur with head involvement, and fracture-dislocation of the hip.
排除标准
- •Conditions that would eliminate or tend to eliminate adequate implant support or prevent the use of an appropriate size implant (blood supply limitations, osteoporosis/metabolic disorders, infections)
- •Mental or neurological conditions impairing or precluding cooperation with post-operative protocols and proper response to PROMs.
- •Skeletal immaturity.
结局指标
主要结局
Harris HIp Score (HHS)
时间窗: 2 years
measures pain, function, absence of deformity and range of motion after hip surgery. This is performed by a qualified health care provider. The higher the score, the better the outcome.
Hip Disablity and Osterarthritis Outcome Score (HOOS)
时间窗: 2 year
Scoring from 0-100 with 0 indicating the worst possible hip symptoms and 100 indicating no symptoms. This tool assesses patients opinion of their hip and associated problems, evaluate symptoms and functional limitations. There are 40 items assessing 5 subscales of: Pain, symptoms, activities of daily living (ADL), function in sport and recreation and Hip related quality of life.
HOOS Jr.
时间窗: 2 year
Scoring from 0-100 with 0 indicating the worst possible hip symptoms and 100 indicating no symptoms. This tool assesses patients opinion of their hip and associated problems, evaluate symptoms and functional limitations. this version is shortened to 6 questions assessing function, pain and quality of life.
次要结局
未报告次要终点