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临床试验/NCT03383640
NCT03383640Unknown不适用

Will Early Active Finger Exercises in Replanted Fingers Improve Mobility? A Prospective Randomized Trial

Oslo University Hospital0 个研究点目标入组 42 人开始时间: 2018年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
42
主要终点
TAM

研究概览

简要总结

A controlled randomized trial, including patients undergoing finger replantation surgery. The Control Group will receive a standardized post operative rehabilitation regime, whilst the Intervention Group will receive a rehabilitation regime that includes early active exercises of the replanted digits.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age over 18 years
  • Total or subtotal amputation injury of 1-4 of the four ulnar digits
  • Injury distal to the MCP joint
  • Must have injured flexor tendon which requires suture
  • Must have a fracture
  • Surgery done with a stable osteosynthesis with acceptable post-operative x-ray imaging
  • The finger must have had a stable circulation for at least 5 days post-surgery

排除标准

  • Arthrodesis/temporary fixation of the MCP joint
  • Bilateral amputation injury
  • Severely damage of other parts if the hand compromising the patient's ability to perform active exercises of the fingers
  • Patients who cannot follow the planned controls

研究组 & 干预措施

Control

No Intervention

Control Group: Standardized post operative rehabilitation, where active exercises of the replanted digits is postponed until radiologic healing of the amputated bone.

Intervention

Other

Intervention Group: Early active exercises of the replanted digits started between day 5 and 7 after surgery, as instructed by hand therapist

干预措施: Active exercises (Other)

结局指标

主要结局

TAM

时间窗: 12 months

Total active movement of the interphalangeal joints

次要结局

  • VAS Function(12 months)
  • Quick-DASH(12 months)
  • Key pinch(12 months)
  • Grip strength(12 months)
  • VAS Pain(12 months)

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

Johanne Korslund

Doctor, orthopaedic surgeon

Oslo University Hospital

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