Intra-Articular Dexamethasone to Prevent Post-Traumatic Osteoarthritis: A Pilot Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- PTOA incidence
研究概览
简要总结
The primary aim of the study is to see if a single wrist injection (intra-articular) of dexamethasone at the time of treatment will reduce the incidence of early-onset of post traumatic osteoarthritis.
详细描述
Our hypothesis is that the intra-articular administration of dexamethasone soon after joint injury will prevent the subsequent development of PTOA, and restore normal joint homeostasis. We plan to generate the data needed to test this hypothesis in a Phase 0 (pilot) clinical trial using patients who have suffered distal radius fractures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unstable distal radius fracture
- •Fracture type AO B1, B2, B3, C1, C2 or C
- •18-65 years old
- •Understand and read English
- •Community dwelling (not in assisted living or NH)
- •Exclusion criteria:
- •Open or bilateral DRF
- •Associated upper extremity carpal fracture or carpal ligament injuries requiring casting or surgical repair at the time of DRF fixation.
- •Greater than 2 weeks post injury
- •Neurologic disorders affecting the hand, wrist or arm.
- •History of permanent dementia, Alzheimer's or other neurologic dx
- •Substance abuse
- •Pathologic fractures
- •Known pregnancy
- •Radiocarpal joint arthritis
排除标准
- 未提供
研究组 & 干预措施
Dexamethasone
Subjects receive dexamethasone (4 mg) injection within the radiocarpal joint either in clinic or in the OR.
干预措施: Dexamethasone (Drug)
Saline
Subjects receive sterile saline (4 mg) injection within the radiocarpal joint either in clinic or in the OR.
干预措施: Saline (Drug)
结局指标
主要结局
PTOA incidence
时间窗: 3 years
Primary outcome measure will incidence of post-traumatic osteoarthritis, determined by joint space narrowing, as measured radiologically.
次要结局
- Patient-rated evaluations(3 years)
- Functional assessment(3 years)
研究者
Sanjeev (Sanj) Kakar, M.D., M.B.A.
PI
Mayo Clinic