跳至主要内容
临床试验/NCT03996512
NCT03996512撤回不适用

Early Active Controlled Motion (EACM) Rehabilitation Protocol Post Open Reduction and Internal Fixation (ORIF) of Scaphoid Fractures: A Pilot Study

University of Florida0 个研究点开始时间: 2019年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
主要终点
functional outcome range of motion

研究概览

简要总结

There is poor research supporting the benefits of Early Active Controlled Motion (EACM) protocols post operative scaphoid fixation. Advances in surgical fixation technique for scaphoid fractures should allow for start of earlier mobilization, however there is little evidence in the literature that supports the use of these protocols within the early phases of healing. The study uses a pre-experimental design with purposeful sample population recruitment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Date of injury and diagnosis: scaphoid fracture less than 3 weeks old
  • •Waist fractures in the middle 1/3 and distal pole 1/3 of scaphoid bone.
  • •Surgical procedure includes ORIF with screw fixation and/or percutaneous pin with screw fixation.
  • •To be included in the study the patient needs to have started rehab within the first 10 days after surgery date.

排除标准

  • •Proximal pole scaphoid fracture
  • •Past medical history of diabetes and other peripheral vascular disorders.
  • •History of osteopenia and osteoporosis.
  • •Previously failed ORIF of scaphoid
  • •Neurovascular or nerve lesion to the involved upper extremity
  • •Cognitive deficits related to memory, attention span, judgment as documented in the EMR or need for a legal guardian to be a medical proxy

研究组 & 干预措施

Post scaphoid fracture with screw fixation

Experimental

Post surgical rehabilitation using an early active controlled wrist motion rehab protocol that limits the amount of proximal carpal row loading forces

干预措施: Early Active Controlled Motion (EACM) (Other)

结局指标

主要结局

functional outcome range of motion

时间窗: at entry and up to 12 months

Using a goniometer measuring the angle of wrist flexion and extension NEED TO ENTER EXPECTED ROM ranges

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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