NL-OMON53013已完成不适用
Comparison of Zimmer Maxera Acetabular System to the Allofit Cup with Roentgen Stereophotogrammetric Analysis (RSA) in Total Hip Arhtroplasty - Maxera RSA
Reinier Haga Orthopedisch Centrum0 个研究点目标入组 54 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
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
- •1. Male and non-pregnant females : <= 75 years
- •2. Patients with a Quetelet index (QI=weight in (kilogram)/ square length
- •(meters)) < 35.
- •3. Patients requiring primary THR, suitable for the use of the Maxera Cup
- •and Allofit Cup.
- •4. The patient is diagnosed with osteoarthritis (OA) or avascular necrosis.
- •5. The individual is physically and mentally willing and able to comply with
- •postoperative functional evaluation and able to participate in an appropriate
- •rehabilitation schedule.
- •6. ASA classification score I-III.
- •7. Patients who signed the Ethics Committee approved specific Informed Consent
- •Form prior to surgery.
排除标准
- •1. Patients who had a THA on contralateral side more than 6 months ago and the
- •rehabilitation period outcome is considered unsatisfactory or not good.
- •(Patients with contra-lateral THA >6 months ago with good outcome (Harris Hip
- •Score >85) can be included in the study).
- •2. Patients who had a THA on contralateral side less than 6 months ago.
- •3. Patients with a major surgical procedure during the 12 weeks before the
- •study-related operation.
- •4. Dutch language not mastered
- •5. The patient is unwilling to cooperate with the study
- •6. The patient is pregnant or desired to be pregnant after surgery or is using
- •inadequate birth control
- •7. Recent Myocardial infarct or CVA (<3 months).
- •8. Mentally disabled patients.
- •9. Patients with a Quetelet index (QI=weight in (kilogram)/ square length
- •(meters)) > 35.
- •10. Any active infection
- •11. Current malignancy
- •12. Uncontrolled hypertension
- •13. Known history of alcohol or drugs abuse.
- •14. ASA IV-V
研究者
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