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临床试验/NCT04716309
NCT04716309进行中(未招募)不适用

Unstable Distal Radius Fractures AO-type A2, A3 and C1 With Dorsal Dislocation in Patients Aged 18-64 Years. Open Reduction and Volar Locking Plate Versus Closed Reduction and Percutaenous Pinning. A Randomized Controlled Trial.

Oslo University Hospital2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年2月16日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
120
试验地点
2
主要终点
Patient-Related Wrist and Hand Evaluation (PRWHE) score

研究概览

简要总结

120 patients age 18-64 years with dorsally displaced distal radius fractures AO-type A2, A3 and C1 are recruited from Oslo Casualty Medical Centre (Oslo Skadelegevakt). Patients are randomized to surgery with closed reduction and pins (CRPP) or open reduction and volar locking plate (VLP). The hypotheses is that CRPP will give equal function and satisfaction to VLP. Patients are followed by current practice of follow-ups until 5 weeks postoperatively, and in addition due to the study with functional tests after 2, 3, 6 and 12 months. These follow-ups will be performed by hand therapist. Scores are also recorded from Patient-Reported Wrist and Hand Evaluation (PRWHE), Quick-Dash (Q-d) and EuroQol Questionnaire (EQ-5D) questionnaires. The main efficacy measure in the study is PRWHE scores after 12 months. There will be X-ray initially, postoperatively and after 12 months. Sub-objectives in the study are analyses of cost-effectiveness (measured by EQ 5D, personnel use, use of additional healthcare service and absence from work), and differences in complications between the two methods.

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
None

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • distal radius fractures of AO- A2, A3 and C1 which should be operated on in accordance with Norwegian guidelines
  • >18 years and <65 years
  • address in Oslo municipality

排除标准

  • multitrauma
  • previous fracture same wrist
  • multiple injuries on the same side
  • not competent to consent
  • dementia / nursing home patient
  • substance abuse
  • foreign / tourists
  • median nerve compression requiring emergency surgery
  • pathological fracture
  • open fracture
  • congenital malformations that make it difficult to interpret data
  • patient does not want surgical treatment
  • not operable due to comorbidity (ASA 4, some ASA 3 after assessment by anesthesiologist)
  • more than 10 days after injury

结局指标

主要结局

Patient-Related Wrist and Hand Evaluation (PRWHE) score

时间窗: 1 year

PROM of 15 questions, score ranging from 0 (best) to 100 (worst)

次要结局

  • Range of motion(1 year)
  • Quick Dash score(1 year)
  • X-ray wrist posterior-anterior and lateral view(1 year)
  • Grip strength(1 year)

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Børge Olsen

MD Børge Olsen

Oslo University Hospital

研究点 (2)

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