Evaluation of the Furlong Evolution Uncemented Hip Prosthesis With Special Emphasize on the Use of Collared Design or Not. A Prospective, Randomized Study Evaluated by RadioStereometric Analysis (RSA) and DXA.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Radiostereometric Analysis (RSA)
研究概览
简要总结
The aim of this study is to further investigate the clinical and radiological importance of design changes in cementless hip prosthesis. The investigators have earlier evaluated the classical Furlong HAC total hip prosthesis and a first design change Furlong Active. Now a further development, Furlong Evolution, is to be evaluated. This prosthesis, furthermore, comes with and without a collar, and the investigators are going to randomize between the two. The investigators hypothesize that the new design will be easier to implant and will present equal or less migration than the older designs which would imply a favourable outcome in the long term. The investigators further hypothesize that the collar play no major part for the long term migration and bone remodelling.
We will now do a 10 year follow up of the patients including RSA, DXA and 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 (Participant)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary osteoarthritis of the hip necessitating primary hip replacement
- •A femur considered suitable for uncemented fixation of the stem
- •Biological age <75 years old at the inclusion time of the study.
排除标准
- •Rheumatoid arthritis
- •Malignant disease
- •Severe osteoporosis
- •Earlier fracture or operation in the hip to be operated on
- •Peroperative fracture
- •Ongoing corticosteroid (oral) or immunosuppressive medication
- •Personal disorders (dementia, alcohol or drug abuse etc) suspected of making completion of the trial uncertain.
研究组 & 干预措施
Stem collar
The stem has two versions, one with and one without a collar. This arm will have stems with a collar. The classical Furlong HAC had a collar.
No Stem collar
The stem has two versions, one with and one without a collar. This arm will have stems without a collar. The classical Furlong HAC had a collar.
干预措施: Stem collar (Procedure)
结局指标
主要结局
Radiostereometric Analysis (RSA)
时间窗: The first postoperative day, 14 days, 3 months, 1, 2, 5 and 10 years
This will measure the change in migration (translation and rotation around the x-, y-, and z-axis of the hip) over time. The migration pattern the first 2 years can predict the long term outcome.
次要结局
- Dual-energy X-ray absorptiometry (DXA)(14 days postoperatively and after 1, 5 and 10 years)
- General health questionnaire(Preoperatively (3-4 weeks) and 1, 2, 5 and 10 years postoperatively)
- Hip specific health questionnaire(Preoperatively (3-4 weeks) and 1, 2, 5 and 10 years postoperatively)
研究者
Gunnar Flivik
Associate professor, MD PhD
Region Skane