ISRCTN91554748进行中（未招募）未知
H1 Hip Resurfacing Arthroplasty
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •1. Patient requires primary hip arthroplasty due to degenerative joint disease (primary osteoarthritis, posttraumatic osteoarthritis, avascular necrosis, developmental hip dysplasia)
- •2. Patients femoral bone stock is adequate for hip resurfacing on plain radiographs
- •3. Patient is between 18 and 70 years old
- •4. Patient willing to comply with study requirements
- •5. Patient plans to be available through 10 years postoperative follow-up
- •6. Patient is able to understand the native language of the country where their procedure is taking place.
排除标准
- •1. Patient has a BMI greater than 40 kg/m²
- •2. Patient suffers from an active inflammatory joint disorder
- •3. Patient has an active infection or sepsis (treated or untreated)
- •4. Patient has insufficient bone stock at the hip (>1/3 necrosis of the femoral head)
- •5. Patient has severe osteopenia or osteoporosis, defined using DXA by T-score of <-2.5 (if T-score does not meet the criteria, please confirm with coordinating site (ICL) for participant eligibility)
- •6. Patient has large and multiple cysts in the femoral head (patients with cysts to be reviewed by coordinating site (ICL) for participant eligibility)
- •7. At the time of enrolment, patient has one or more of the following arthroplasties that have been implanted less than 6 months before the current hip arthroplasty:
- •7.1. Contralateral primary total hip arthroplasty or hip resurfacing arthroplasty
- •7.2. Ipsilateral or contralateral primary total knee or unicondylar knee arthroplasty
- •8. Patient takes medications which potentially affect the bone such as corticosteroids and antimitotic medications
- •9. Patient has a condition that may interfere with the hip arthroplasty survival or outcome (i.e., Paget’s or Charcot’s disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease)
- •10. Patient has a known alcohol or drug abuse
- •11. Patient has an immunosuppressive disorder
- •12. Patient has a malignant tumour, metastatic, or neoplastic disease
- •13. Patient has severe comorbidities or a limited life expectancy
- •14. Patient lacks capacity to consent
- •15. Patient has an emotional or neurological condition that would pre-empt his/her ability or willingness to participate in the study
- •16. Patient is not willing or able to sign an informed consent form
- •17. Patient pregnant or breast feeding
- •18. Patient is not able or willing to come to follow-up visits
- •19. Any other clinical reason, which the investigator considers would make the patient unsuitable for the trial
- •20. Implant size unavailable
研究者
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