Link LCU + Lima Delta TT vs DePuy Corail + Pinnacle. A Comparative Study of Stem and Cup Fixation and Polyethylene Wear
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Femoral stem migration
研究概览
简要总结
A randomized controlled study comparing two types of cementless femoral stems (LCU and Corail) and two types of acetabular components (DeltaTT and Pinnacle Duofix) in primary total hip arthroplasty. Primary outcome are component migration measured by RSA, wear and patient reported outcome. Patients are evaluated up to 15 years postoperatively.
详细描述
Material Patients The study will be conducted according to GCP, (Good Clinical Practice). Potential clinical study participants will be identified from the THR waiting list of Umeå University Hospital. The enrolment process will involve a review of the patient history from the medical records in order to match available patient details with the inclusion/exclusion criteria (see below). Patients considered suitable for potential study enrolment will be contacted by a member of the research team to ascertain their level of interest in participating in this study.
Once verbal and written informed consent is provided a medical profile will be taken.
Inclusion criteria:
Primary or secondary osteoarthritis of the hip Male and non-pregnant female patients aged 18 to 70 years of age Type A or B femur Patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow-up
Exclusion criteria BMI under 18 and over 35 Inflammatory arthritis Osteoporosis Paget's disease Grossly abnormal hip anatomy (severe dysplasia) Previous operations in the same hip Presence of malignancy Patients who, as judged by the surgeon, are mentally incompetent or are reasonable unlikely to be compliant with the requirements of the study Patient is female of child-bearing age and not taking contraceptive precautions
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
- 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
- •Primary or secondary osteoarthritis of the hip
- •Male and non-pregnant female patients aged 18 to 70 years of age
- •Type A or B femur
- •Patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow-up
排除标准
- •BMI under 18 and over 35
- •Inflammatory arthritis
- •Osteoporosis
- •Paget's disease
- •Grossly abnormal hip anatomy (severe dysplasia)
- •Previous operations in the same hip
- •Presence of malignancy
- •Patients who, as judged by the surgeon, are mentally incompetent or are reasonable unlikely to be compliant with the requirements of the study
- •Patient is female of child-bearing age and not taking contraceptive precautions
结局指标
主要结局
Femoral stem migration
时间窗: 1-15 years
Migration measured in millimetres per year with radiostereometric (RSA) analysis of radiographs.
Cup Migration
时间窗: 1-15 years
Migration measured in millimetres per year with radiostereometric (RSA) analysis of radiographs. Radiostereometric analysis (RSA) is a stereo X-ray technique used in clinical research studies to evaluate micro-motion and wear of orthopaedic implants within bone. The method has a high accuracy and precision. Technical requirements include the need for implanted marker beads and radiograph view angles determined by a calibration cage.
Wear
时间窗: 1-15 years
The size of the femoral component penetration into the polyethylene measured in millimeters per year and the volumetric annual wear millimetres with radiostereometric (RSA) analysis of radiographs.
次要结局
- Patient reported outcome measurement(1-15 years)
- University of California, Los Angeles (UCLA) activity scale(1-15 years)
- Movement between liner and acetabular components(1-15 years)
- Harris Hip Score(1-15 years)
- EQ5D(1-15 years)
- Visual Analog Scale(1-15 years)
- Short Form Health Survey(1-15 years)