Roentgen Stereophotogrammetric Analysis (RSA): ACTIS Hip Stem
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 6
- 主要终点
- Subsidence of the ACTIS femoral stem
研究概览
简要总结
The principal objective of this study is to compare mean 2-year subsidence of the ACTIS femoral stem using model-based RSA against published migration patterns for hip stems of a similar design. Secondary objectives include comparison of migration per surgical approach, quantifying changes in functional and health status of subjects following surgery, and assess occurrences of complications and adverse events.
详细描述
This is a multi-centre, sequential enrollment trial of patients undergoing primary total hip arthroplasty. Patients will be recruited at three Canadian Centres to receive the ACTIS femoral hip stem via 3 different surgical approaches.
Model-based RSA will identify migration of the implant with respect to the femoral bone during the first 2 post-operative years. Patient health and functional outcomes will be recorded at pre- and post-operative intervals to quantify improvement as a result of the surgery and trajectory of recovery. Adverse events and clinical complications in each study group will be captured and compared. Select surgical, hospital and rehabilitation data will be collected to measure health economic outcomes relating to the surgery.
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
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Symptomatic osteoarthritis of the hip indicating primary total hip arthroplasty
- •Aged 21 years or older
- •Patients willing and able to comply with follow-up requirements and self-evaluations
- •Ability to give informed consent
- •Body mass index ≤45 kg/m2
排除标准
- •Active or prior infection
- •Medical condition precluding major surgery
- •Medical condition with less than 2 years life expectancy
- •Overhanging pannus (for anterior approach cohort only)
- •Prior surgery of the hip involving implantation of hardware (i.e., hemiarthroplasty, internal fixation, pelvic reconstruction near the acetabulum requiring removal)
- •Skin condition on the area of incision
- •Multi-level lumbar spine fusion
- •Ankylosing spondylolithesis
- •Shortening osteotomy through the femur
结局指标
主要结局
Subsidence of the ACTIS femoral stem
时间窗: 2 Year
Compare mean 2-year subsidence using model-based RSA (radiostereometric analysis) (mm). The images taken at each time point will be compared with the baseline to assess the change in implant position.
次要结局
- Oxford Hip Score (OHS)(Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years)
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years)
- University of California at Los Angeles (UCLA) Activity Level scale(Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years)
- Comparison of migration per surgical approach(2 Year)
- European Quality of Life (EQ-5D-5L) questionnaire(Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years)
- Visual analogue scale (VAS) for thigh pain(Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years)
- Visual analogue scale (VAS) for satisfaction(Preoperative, 6 Weeks, 3 Months, 6 Months, 1 Year and 2 Years)