Selection of Hip Prosthesis for Younger Patients? Primoris® Short Femur Component vs. Echo® Standard Femur Component. Comparison of Bone Re-modeling, Prosthetic Migration and Gait Function. Controlled Randomized Study of 60 Patients.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Bone Mineral Density
研究概览
简要总结
There have been no previously published clinical randomized studies comparing Primoris®, short stem, hip prosthesis with standard uncemented hip arthroplasty in relation to bone density and function development. This is the subject for this study.
详细描述
The overall purpose of this study is to show whether the Primoris® hip prosthesis results in a smaller loss of bone density than standard hip prosthesis, which in the longer term may result in an improved survival of prosthesis No. 2 after revision / replacement of a Primoris® hip prosthesis.
The primary outcome is periprosthetic bone quality in Primoris® hip prosthesis compared to standard hip prosthesis measured by DXA scanning.
The secondary outcomes are to assess:
- The hip function measured by gait analysis.
- Hip strength at pressure gauge.
- Prosthetic migration / migration measured by radio-stereometric analysis (RSA).
- Patient satisfaction measured by PROMs.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women ≤ 45 years or men ≤ 55 years with hip osteoarthritis, suitable for hip prosthesis.
- •Patients who wish to participate in the project and give written consent after oral and written information.
排除标准
- •Patients with previous bone disease, metabolic disease, including diabetes, or the use of drugs that affect bone density.
- •Smoking more than 20 cigarettes daily
- •Patients with fracture in the femur or acetabulum.
- •Patients who do not understand the given patient information
- •Competing disorder requiring treatment with antiinflammatory drugs (NSAIDs, steroid, cytostatics).
- •Estimated residual life <10 years
- •Rheumatoid arthritis or other arthritis (eg psoriasis arthritis).
- •Previous surgery on the relevant hip joint.
- •Co-Morbidity (ASA Group 3-5).
- •Neurological disorder that compromises motor skills and rehabilitation.
- •Osteoarthritis secondary to mb. Calvé-Legg-Perthes / Avascular Caput Necrosis, Epiphysiolysis Capitis Femoris and Multiple Epiphysic Dysplasia.
- •Acetabular dysplasia with secondary subluxation (Crowe grade II to IV).
- •Previously detected osteoporosis or osteoporosis detected by current DXA scanning.
- •Ongoing treatment with osteoporosis medicine (bisphosphonates, estrogen receptor modulators and parathyroid hormone, etc.).
- •Aseptic caput necrosis (posttraumatic, idiopathic).
- •Varus or valgus deformity in proximal femur (collum angle <125 ° or> 145 °.)
- •Collum femoris assessed too retro- or anteverted.
研究组 & 干预措施
Primoris
Total hip arthroplasty surgery using a Primoris® femur component, Exceed ® acetabular cup + E-poly liner ®.
干预措施: Total Hip Arthroplasty (Procedure)
Echo
Total hip arthroplasty surgery using a standard uncemented Echo® femur component, Exceed ® acetabular cup + E-poly liner ®.
干预措施: Total Hip Arthroplasty (Procedure)
结局指标
主要结局
Bone Mineral Density
时间窗: 2 -10 years
Bone density around the prosthesis measured by serial Dual X-ray Absorptiometry (DXA) scans.
次要结局
- European Quality of life in 5 Dimensions (EQ5D)(2-10 years)
- Gait analysis(1 year)
- University of California Los Angeles Activity Score (UCLA)(2-10 years)
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(2-10 years)
- Forgotten Joint Score (FJS)(2-10 years)
- Radio Stereometric Analysis (RSA)(2-10 years)
- Oxford Hip Score (OHS),(2-10 years)
- Harris Hip Score (HHS)(2-10 years)