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临床试验/NCT05623540
NCT05623540已完成不适用

Postoperative Use of Bisphosphonates Reduces Adverse Outcome After Primary Total Joint Arthroplasty: A Nationwide Population-based Cohort Study

National Defense Medical Center, Taiwan1 个研究点 分布在 1 个国家目标入组 27,405 人开始时间: 2000年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
27,405
试验地点
1
主要终点
revision rate of joint arthroplasty

研究概览

简要总结

Background Bisphosphonates has been associated with a decreased risk of revision total joint replacements because of its effects on decreased periprosthetic bone loss and prosthetic migration. However, the results in the early literature are inconsistent and the influence of bisphosphonates on associated complications and subsequent total joint arthroplasty (TJA) remains unknown. This study is to investigate the association between the use of bisphosphonates and risk of adverse outcomes after primary TJA.

Materials and Methods This matched cohort study utilized National Health Insurance Research Database in Taiwan to identify patients who underwent primary TJA over a 15-year period (January 2000- December 2015 inclusive). Study participants were further categorized into two groups: bisphosphonates users and nonusers, using propensity score matching. The Kaplan-Meier curve analysis and adjusted hazard ratios (aHR) of revision surgery, adverse outcomes of primary surgery and undergoing subsequent TJA were calculated using Cox regression analysis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who underwent primary total joint arthroplasty during the study period (January 1, 2000 to December 31, 2015).

排除标准

  • Patients with total joint arthroplasty before the index date,
  • Patients with existing pathologic fracture, nonunion of fracture and partial joint replacement,
  • Patients who were lost to follow-up
  • Patients < 40 years old

研究组 & 干预措施

bisphosphonates users

Patients who underwent primary total joint arthroplasty with bisphosphonates use

干预措施: Bisphosphonates, Combinations (Drug)

bisphosphonates nonusers

Patients who underwent primary total joint arthroplasty without bisphosphonates use

干预措施: Bisphosphonates, Combinations (Drug)

结局指标

主要结局

revision rate of joint arthroplasty

时间窗: a 15-year period (January 2000- December 2015 inclusive)

revision rate of joint arthroplasty after primary surgery

次要结局

  • Mortality rate(a 15-year period (January 2000- December 2015 inclusive))
  • The rate of secondary total joint arthroplasty(a 15-year period (January 2000- December 2015 inclusive))
  • The rate of periprosthetic joint infection(a 15-year period (January 2000- December 2015 inclusive))
  • The rate of periprosthetic fracture(a 15-year period (January 2000- December 2015 inclusive))

研究者

发起方
National Defense Medical Center, Taiwan
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jen-Ta Shih

Lecturer, department of Orthopedics, school of Medicine

National Defense Medical Center, Taiwan

研究点 (1)

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