NL-OMON42137尚未招募不适用
RadioStereometric Analysis of the Plus orthopedics SL-MIA stem and the SL-stem, a randomised controlled trial. - RSA of the SL-MIA Plus and SL-Plus stem, a RCT
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •Patients with primary osteoarthritis of the hip with an indication for total hip arthroplasty.
- •Age 50 to 80
- •ASA 1 and 2
- •unilateral coxartrhosis
- •Informed consent of patient
- •Initial willingness to comply with the post-operative review program
排除标准
- •Ability to comply to the postoperative investigational program
- •THA or osteosynthesis on the contra lateral hip (not suitable as reference during DEXA-scan)
- •Expectation that the contra lateral hip also needs a THA within a year
- •THA because of fracture
- •Prior surgery on effected hip
- •Revision arthroplasty
- •Acute or chronic infections (local or systemic)
- •Metabolic diseases of the bone
- •Diseases of the muscular, nervous, or vascular systems that seriously will involve the mobility of the patient after a THA
- •Femora with structural defects or poor bone quality affecting the stability of the prosthesis
- •Any concomitant disease which may endanger the implant*s function
- •Patients with rheumatic, renal, hepatic or gastrointestinal disease and patients using medication that interferes with mineral metabolism (i.e. treatment for osteoporosis or long-term steroid therapy).
研究者
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