跳至主要内容
临床试验/NCT03196310
NCT03196310终止不适用

Randomized Single Blinded First CMC Osteoarthritis Treatment: Therapy and Bracing Alone vs. Intra-Articular Corticosteroid Injection vs Intra-Articular Leukocyte Depleted Platelet Rich Plasma

Kettering Health Network2 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2018年9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
终止
入组人数
74
试验地点
2
主要终点
Disabilities arm shoulder and hand score

研究概览

简要总结

Single blinded PRP vs. Corticosteroid vs. Placebo (normal saline) intra-articular injection for basal joint arthritis.

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
Single (Participant)

盲法说明

Patients will be blinded to therapy they receive

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

  • Stage 1-3 osteoarthritis of the basal joint

排除标准

  • Patients with Stage 4 1st carpometacarpal joint arthritis as described by Eaton
  • Patients who have received a corticosteroid injection in the last year to the 1st CMC joint on the proposed study side
  • Patients who have scaphotriquetral, radioscaphoid, or scaphotrapezial osteoarthritis
  • Patients who have concurrent DeQuervain's tenosynovitis or intersection syndrome or have been treated for either of these in the last 3 months
  • Patients undergoing evaluation of cervical radiculopathy
  • Patients with fibromyalgia or inflammatory rheumatic disease
  • Patients with Pressier disease, Kienbock's, or avascular necrosis of the scaphoid
  • Patients with any history of primary or secondary bone tumor
  • Patients that are pregnant or terminally ill

研究组 & 干预措施

PRP

Experimental

Intra-articular injection of platelet rich plasma.

干预措施: Platelet Concentrate (Drug)

Normal Saline

Placebo Comparator

Intra-articular injection of normal saline

干预措施: Normal Saline (Other)

Corticosteroid

Active Comparator

Intra-articular injection of kenalog.

干预措施: Corticosteroid injection (Drug)

结局指标

主要结局

Disabilities arm shoulder and hand score

时间窗: 1 year

functional score

次要结局

  • Pinch Strength(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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