ACTRN12611000095965尚未招募未知
In patients with non-inflammatory joint disease who qualify for total hip replacement (THR) surgery, does insertion of the Nanos short stem femoral component enhance clinical outcomes?
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 21 Years 至 60 Years（—）
- 性别
- All
入选标准
- •6.1Inclusion Criteria
- •1. The individual has signed a Patient Informed Consent (PIC”), specific to this study, and approved by the Institutional Ethics Review Board.
- •2. The individual is between the ages of 21 and 60 years.
- •3. The individual is not classified as obese.
- •4. The individual clinically qualifies for total hip arthroplasty surgery based on physical examination and medical history.
- •5. The individual is diagnosed with Non Inflammatory Degenerative Joint Disease (osteoarthritis, traumatic arthritis, avascular necrosis, dysplasia).
- •6. The individual does not have an active infection within the affected hip joint.
- •7. The individual has not had a previous total hip replacement or hip fusion of the affected hip joint.
- •8. The individual is physically and mentally willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation (i.e., not currently being treated for a psychiatric disorder, senile dementia, Alzheimer’s disease, presence of alcohol or substance abuse).
- •9. The individual does not have a neuromuscular nor neurosensory deficiency, which limits the ability to evaluate the safety and effectiveness of the device.
- •10. The individual does not have a diagnosed systemic disease that would affect the subject’s welfare or overall outcome of the study (i.e., moderate to severe osteoporosis, Paget's disease, renal osteodystrophy), is not immunologically suppressed, or receiving steroids in excess of physiologic dose requirements.
- •11. The individual is skeletally mature.
- •12. The individual is not pregnant.
- •13. The individual is not a prisoner.
- •14. The individual has no plans to relocate to another geographic area before the completion of the study.
排除标准
- •6.2Exclusion Criteria
- •1. The individual has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and effectiveness of the device.
- •2. The individual has any type of radiologically detected osteopenia.
- •3. The individual has pronounced coxa valga with a femoral neck angle > 145° or coxa vara with a femoral neck angle < 125°.
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