Prospective Study for Evaluation of Proximally Anchored (Metaphysis) Cementless Femoral Component for Total Hip Arthroplasty. 10 Year Clinical Evaluation,DXA and RSA Follow-up of Primoris® Femoral Component.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 350
- 试验地点
- 2
- 主要终点
- RSA
研究概览
简要总结
Using the traditional and hitherto used uncemented hip prostheses achieved good clinical results, but one of the drawbacks is the risk of fracture in the femoral shaft in indbankning of the prosthesis (1-2%). In addition, the bone scan demonstrated that in the years after surgery dropped almost 30% of bone mass in the femoral shaft. This bone loss increases the risk that in the years after surgery, the increased risk of fractures around the prosthesis and in addition to impeding the described bone replacement prosthesis later.
The newly developed prosthesis is anchored in the femoral neck and thus not involve the femoral shaft. This ensures a more physiological or normal weight transfer to the femur bone.
This contributes to bone mass in long large extent preserved in the years after surgery, so you have a better opportunity later to make a new prosthesis surgery with good results. The new prosthesis should be capable of simultaneously reducing the incidence of thigh pain in the first year after surgery.'
详细描述
By insertion of artificial hip joints in young and middle aged are often used so-called uncemented technique in which the prosthesis is fixed to the bone without the use of bone cement. Anchoring happens when the bone cells grow into the prosthesis porous surface, thereby creating a stable anchorage of the prosthesis, both short and long term.
A hip prosthesis consists of 3 main elements:
- socket
- ball
- femoral component, which hold ball. Femoral component is anchored to the upper end of the femur including the upper 12-15 cm of the marrow cavity.
Achieved good results with this principle. The method involves a risk of fracture at the top end of the femur bone during and after insertion of the prosthesis, but also that there is some bone loss in the year after surgery. Finally there is a 3-10% chance that you get thigh pain due to different elasticity of the femur and the long shank prosthesis.
Based on the foregoing disadvantages of the femoral components, which are commonly used, has for years been experimenting with the introduction of shorter implants, which are either anchored in the femoral neck or femoral neck combined with the very top end of the femur bone (metaphysis). By using such a prosthesis, it is proven to preserve the bone in the upper femur forward and avoids the disadvantage in terms of the above described femoral pain. There is also described problems by using these short prostheses, especially in the form of solution, and pain secondary to anchor bolts in the upper femur forward.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •younger OA patients with good bonestock
排除标准
- •Patients who do not understand the given information to patients
- •Competing disorder requiring treatment with anti-inflammatory drugs (NSAIDs, steroids, cytostatics).
- •Estimated remaining life expectancy < 10 years
- •Rheumatoid arthritis or other arthritis (eg psoriatic arthritis).
- •Previous surgery on relevant hip.
- •Pain Normative and disabling osteoarthritis of the ipsilateral knee.
- •Co-mobiditet (ASA-group 3-5).
- •Neurological disorder which compromises the motor skills and rehabilitation courses.
- •Osteoarthritis secondary to Calvé-Legg-Perthes' disease and juvenile epifysiolysis coxae.
- •Acetabular dysplasia and secondary subluxation (Crowie grade II to IV).
- •Previously established osteoporosis or osteoporosis detected by current DEXA scan.
- •Ongoing treatment with osteoporosis medications (calcium and vitamin D, bisphosphonates, estrogen receptor modulating agents and parathyroid hormone, etc.).
- •Aseptic caputnekrosis (post-traumatic, idiopathic).
- •Deform the femoral neck (femoral length, measured medially ≤ 15 mm)
- •Varus or valgus deformity in proximal femur inc. femoral (Collum angel < 125 ° or > 145 °.)
- •Retroversion or anteversion femur.
结局指标
主要结局
RSA
时间窗: 2 years
radio stereographic analysis for prosthesis migration
次要结局
- Western Ontario and McMaster Universities Arthritis Index (WOMAC)(10 years)
- Harris Hip score(10 years)