ISRCTN86833638已完成不适用
The ATX registry - accolade stem & Trident/Tritanium cup with X3 insert international multicentre surveillance register
Stryker European Operations BV (Netherlands)0 个研究点目标入组 478 人开始时间: 2012年8月17日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 478
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
- •Current inclusion criteria as of 26/08/2014:
- •1. Male and non-pregnant female patients between 18-75 years of age
- •2. Patients requiring uncemented primary THA, suitable for the use of the Accolade stem and Trident/Tritanium cup
- •3. Patients with a diagnosis of osteoarthritis (OA)
- •4. Patients who understand the conditions of the study and are willing and able to comply with the post-operative scheduled clinical and radiographic evaluations and the prescribed rehabilitation
- •5. Patients who signed the Ethics Committee approved Informed Consent Form prior to surgery
- •Previous inclusion criteria:
- •1. Male and non-pregnant female patients between 18-70 years of age
- •2. Patients requiring uncemented primary THA, suitable for the use of the Accolade stem and Trident/Tritanium cup
- •3. Patients with a diagnosis of osteoarthritis (OA)
- •4. Patients who understand the conditions of the study and are willing and able to comply with the post-operative scheduled clinical and radiographic evaluations and the prescribed rehabilitation
- •5. Patients who signed the Ethics Committee approved Informed Consent Form prior to surgery
排除标准
- •1. Patients who require revision of a previously implanted hip prosthesis
- •2. Patients who had a THA on contralateral side within the last 6 months
- •3. Patients who had a THA on contralateral side more than 6 months ago and the rehabilitation period outcome was considered unsatisfactory or not good (Harris Hip Score < 85)
- •4. Patients who will need lower limb joint replacement for another joint within one year
- •5. Patients requiring bilateral hip replacement
- •6. Patients who have had a prior procedure of acetabular osteotomy
- •7. Patients with acute femoral fractures
- •8. Obese patients where obesity is severe enough to affect subject?s ability to perform activities of daily living (body mass index, kg/m2: BMI = 35)
- •9. Patients with active or suspected infection
- •10. Patients with malignancy ? active malignancy
- •11. Patients with severe osteoporosis, rheumatoid arthritis (RA), Paget?s disease or renal osteodystrophy
- •12. Patients immunologically suppressed, or receiving steroids in excess of physiologic dose requirements
- •13. The patient has a neuromuscular or neurosensory deficit which would limit their ability to assess the performance of the device or the patient has a neurological deficit which interferes with the patient?s ability to limit weight bearing or place an extreme load on the implant during the healing period
- •14. Female patients planning a pregnancy during the course of the study
- •15. Patients with systemic or metabolic disorders leading to progressive bone deterioration
- •16. Patients, who as judged by the surgeon, are mentally incompetent or are unlikely to be compliant with the prescribed post-operative routine and follow-up evaluation schedule
- •17. Patients with other severe concurrent joint involvements, which can affect their outcome
- •18. Patients with other concurrent illnesses, which are likely to affect their outcome such as sickle cell anaemia, systemic lupus erythematosus or renal disease requiring dialysis
- •19. Patient with a known sensitivity to device materials
- •20. Patients under the protection of law (e.g. guardianship)
研究者
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