Efficacy of a New Resurfacing Hip Prosthesis. A Multicenter, Prospective, Randomized, Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 12
- 主要终点
- pre planned position of the femoral component preoperatively (stem-shaft-angle)
研究概览
简要总结
The purpose of this study is to compare the articular surface replacement (ASR) prosthesis placed by the conventional positioning method and the ASR prosthesis placed by 'computer assisted surgery' (CAS) in variation between pre planned position of the femoral component and the actual position of the femoral component of the prosthesis. The hypothesis is that this variation is larger with the conventional positioning method than when CAS is used.
详细描述
For patients who suffer from end stage of osteoarthritis of the hip, a joint replacement could result in an obvious improvement of the quality of life. However, because of the life expectation and high level of activity of young and active patients, the conventional total hip replacement does not offer an optimal solution.
An alternative to a total hip replacement in young and active patients is the resurfacing hip prostheses. The articular surface replacement (ASR) hip prostheses can be placed by the conventional positioning method and by using 'computer assisted surgery' (CAS). The hypothesis is that the positioning of the femoral component by the conventional positioning method will show a larger variation between pre planned and actual position than when CAS is used.
This study will compare the results of those who had an ASR prosthesis placed by the conventional positioning method with those patients in whom the ASR prosthesis was placed using CAS.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men aged ≤ 60 years, and women aged ≤ 55 years
- •Presence of evident clinical and radiological osteoarthritis of the hip, indicated for a joint replacement surgery
排除标准
- •Evident osteoporosis
- •Active local or systemic infection
- •Clinical manifestation of vascular deficiency of the lower extremity
- •Pathological condition of the acetabulum
- •Presence of evident clinical and radiological avascular necrosis of the femoral head, hip dysplasia, slipped capital femoral epiphysis, Legg-Calve- Perthes disease
- •Rheumatoid arthritis
- •Extreme varus position (neck-shaft angle < 110º)
- •Presence of femoral cyst > 1 cm in diameter
- •Previous hip surgery
- •Presence of bilateral hip pathology, which may lead to joint replacement surgery within 1 year
- •Presence of a THR at the contra lateral site less than 6 months post- operatively or patients with a THR at the contra lateral site with a poor function of the hip
- •BMI> 30 kg/m2
- •Renal deficiency (creatine > 115 μmol/l for men and > 90 μmol/l for women)
- •Medically proven metal allergy
- •Request of patient to correct an existing leg length discrepancy
- •Head-neck ratio < 1
- •Use of steroids, and/or immunosuppressive medication
- •Alcoholism
- •Patients from which it is not sure that they will be able to attend the follow-up measurements
- •Insufficient command of the Dutch language, spoken and/of written
研究组 & 干预措施
1
ASR prosthesis placed using CAS
干预措施: Articular Surface Replacement (ASR) hip prosthesis (Device)
2
ASR prosthesis placed by conventional method
干预措施: Articular Surface Replacement (ASR) hip prosthesis (Device)
结局指标
主要结局
pre planned position of the femoral component preoperatively (stem-shaft-angle)
时间窗: within 8 weeks before surgery
actual position of the femoral component postoperatively (stem-shaft-angle)
时间窗: within one week after surgery
次要结局
- Physical Activity Scale for Individuals with Physical Disabilities (PASIPD)(preoperatively and at 6 weeks, 3, 12, 24 and 36 months postoperatively)
- Quality of life(preoperatively and at 6 weeks, 3, 12, 24 and 36 months postoperatively)
- Early complications(within 3 months after surgery)
- Harris Hip Score(preoperatively and at 6 weeks, 3, 12, 24 and 36 months postoperatively)
- Percentage of dynamic and static activities measured by the Rotterdam Activity Monitor (RAM)(preoperatively and at 3 and 6 months postoperatively)
- Hip pain(preoperatively and at 6 weeks, 3, 12, 24 and 36 months postoperatively)
- Later complications(longer than 3 months after surgery)
- Assessments of the position of femoral component (biomechanical parameters) at the X-rays(preoperatively, during the clinical phase and at 6 weeks, 3, 12, 24 and 36 months postoperatively)
研究者
maaike vissers
PhD
Erasmus Medical Center