跳至主要内容
临床试验/NCT05875896
NCT05875896已完成不适用

Investigation of the Functional Status After Wrist Arthrodesis (Medartis Aptus Model) in Patients With Rheumatoid Arthritis Compared to Patients With Post-traumatic Wrist Destruction

Waldfriede Hospital1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2023年6月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
73
试验地点
1
主要终点
Disabilities of the Arm, Shoulder and Hand questionnaire (DASH)

研究概览

简要总结

The primary working hypothesis of this study is whether wrist arthrodesis leads to an improvement in functional status in both rheumatoid arthritis and post-traumatic osteoarthritis. Functional status will be measured by Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire no earlier than 1 year after surgery.

研究设计

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

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-90
  • Wrist fusion took place between 2014 and 2022 using Aptus 2.5 TriLock Total Wrist Fusion Plate, Medartis at Hospital Waldfriede
  • rheumatoid Arthritis
  • post-traumatic osteoarthritis patterns:
  • scapholunate advanced collapse (SLAC) or
  • scaphoid nonunion advanced collapse (SNAC)

排除标准

  • post surgery bone fracture of the same limb
  • Pregnancy, lactation
  • active malignant tumor

结局指标

主要结局

Disabilities of the Arm, Shoulder and Hand questionnaire (DASH)

时间窗: all patients who underwent surgery between 2014 to 2022

Disabilities as measured by the DASH scale; No Difficulty (1), Mild Difficulty (2), Moderate Difficulty (3), Severe Difficulty (4), Unable (5)

次要结局

  • Functional assessment: Goniometry(all patients who underwent surgery between 2014 to 2022)
  • Function(all patients who underwent surgery between 2014 to 2022)
  • Postoperative complications(all patients who underwent surgery between 2014 to 2022)
  • Visual analogue scale (VAS) Pain(all patients who underwent surgery between 2014 to 2022)
  • Short-Form 36 (SF-36)(all patients who underwent surgery between 2014 to 2022)

研究者

发起方
Waldfriede Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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