跳至主要内容
临床试验/NCT04441112
NCT04441112已完成2 期

Intraarticular Injections of the Hip and Knee With Triamcinolone Versus Ketorolac: A Randomized Controlled Trial

Saint Alphonsus Regional Medical Center1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年5月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
120
试验地点
1
主要终点
Change in Visual Analogue Scale (Baseline to One Week Post-injection)

研究概览

简要总结

Clinicians commonly utilize intraarticular injections to treat symptomatic primary arthritis. Steroid injections are common yet have immune-modulating effects and can alter gene expression which may delay definitive arthroplasty and further damage cartilage. Non-steroidal anti-inflammatory (NSAID) injections may offer a safer profile due to their differing mechanism of action; however, there is a relative dearth of information regarding their efficacy. This non-inferiority study compares the effectiveness of triamcinolone versus ketorolac in treating symptoms of moderate to advanced primary osteoarthritis of the hip and knee.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

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

入选标准

  • Symptomatic, radiographically proven degenerative joint disease in the hip or knee

排除标准

  • recent injection in the hip or knee within the previous 3 months
  • history of traumatic osteoarthritis or ligamentous reconstruction
  • chronic narcotic use
  • history of inflammatory or neuropathic arthropathy
  • pregnant and/or nursing women
  • allergy or strong reaction to study medications

研究组 & 干预措施

Ketorolac Intraarticular Hip Injection

Experimental

Patients will receive an intraarticular hip injection with ketorolac.

干预措施: Ketorolac Intraarticular Injection (Drug)

Triamcinolone Intraarticular Hip Injection

Active Comparator

Patients will receive an intraarticular hip injection with triamcinolone.

干预措施: Triamcinolone Intraarticular Injection (Drug)

Ketorolac Intraarticular Knee Injection

Experimental

Patients will receive an intraarticular knee injection with ketorolac.

干预措施: Ketorolac Intraarticular Injection (Drug)

Triamcinolone Intraarticular Knee Injection

Active Comparator

Patients will receive an intraarticular knee injection with triamcinolone.

干预措施: Triamcinolone Intraarticular Injection (Drug)

结局指标

主要结局

Change in Visual Analogue Scale (Baseline to One Week Post-injection)

时间窗: Comparing baseline to one week post-injection

Pain Score

Change in PROMIS Global Health Scores (Baseline to One Month Post-injection)

时间窗: Comparing baseline to one month post-injection

Overall patient wellbeing

Change in Visual Analogue Scale (Baseline to One Month Post-injection)

时间窗: Comparing baseline to one month post-injection

Pain Score

Change in Visual Analogue Scale (Baseline to Three Months Post-injection)

时间窗: Comparing baseline to three months post-injection

Pain Score

Change in PROMIS Global Health Scores (Baseline to One Week Post-injection)

时间窗: Comparing baseline to one week post-injection

Overall patient wellbeing

Change in PROMIS Global Health Scores (Baseline to Three Months Post-injection)

时间窗: Comparing baseline to three months post-injection

Overall patient wellbeing

Change in Knee Injury and Osteoarthritis Outcome Score Jr. (Baseline to One Week Post-injection)

时间窗: Comparing baseline to one week post-injection

Functionality and pain of affected knee

Change in Knee Injury and Osteoarthritis Outcome Score Jr. (Baseline to One Month Post-injection)

时间窗: Comparing baseline to one month post-injection

Functionality and pain of affected knee

Change in Knee Injury and Osteoarthritis Outcome Score Jr. (Baseline to Three Months Post-injection)

时间窗: Comparing baseline to three months post-injection

Functionality and pain of affected knee

Change in Hip Injury and Osteoarthritis Outcome Score Jr. (Baseline to One Week Post-injection)

时间窗: Comparing baseline to one week post-injection

Functionality and pain of affected hip

Change in Hip Injury and Osteoarthritis Outcome Score Jr. (Baseline to One Month Post-injection)

时间窗: Comparing baseline to one month post-injection

Functionality and pain of affected hip

Change in Hip Injury and Osteoarthritis Outcome Score Jr. (Baseline to Three Months Post-injection)

时间窗: Comparing baseline to three months post-injection

Functionality and pain of affected hip

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kevin Jurgensmeier

Medical Student

Saint Alphonsus Regional Medical Center

研究点 (1)

Loading locations...

相似试验