CTRI/2019/08/020540招募中未知
Study of spinal sagittal balance in Indian population along with social & economic perspective. - SB
Stavya spine hospital and research institute private limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
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
入选标准
- •Age â?? 50 and above
- •Male / female
- •Physically fit and mentally
- •Psycho-social, mentally and physically able to fully comply with this protocol including adhering to completing forms and other study procedures.
- •Personally signed and dated informed consent document prior to
- •Any study-related procedures indicating that the patient has been informed of all pertinent aspects of the study.
排除标准
- •1. Patients with heart disease, severe organ insufficiency
- •2. Patients with Diffused Idiopathic Skeletal Hyperostosis (DISH);
- •3. Active systemic or local infection;
- •4. Known or documented history of communicable disease, including AIDS or HIV;
- •5. Active hepatitis (receiving medical treatment within two years);
- •6. Active rheumatoid arthritis, non-controlled diabetes mellitus, or any other medical condition(s) that would represent a significant increase in surgical risk or interfere with normal healing;
- •7. Immunologically suppressed, or has received systemic steroids, excluding nasal steroids, at any dose daily for > 1 month within last 12 months;
- •8. Known history of Pagetâ??s disease, osteomalacia, or any other metabolic bone disease;
- •9. Previous known allergy to the materials contained in the device, such as titanium alloy (TAN);
- •10. Morbid obesity defined as a body mass index > 40 kg/m2 or weight more than 100 pounds over ideal body weight;
- •11. Active malignancy. A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless treated with curative intent and there has been no clinical signs or symptoms of the malignancy for more than 5 years;
- •12. Current or recent history (within last 2 years) of substance abuse (e.g., recreational drugs, narcotics, or alcohol);
- •13. Pregnant or planning to become pregnant during study period;
- •14. Patients who are incarcerated.
- •15. Patients who have limited life expectancy due to significant medical comorbidities.
研究者
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