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临床试验/NCT02441790
NCT02441790撤回不适用

Early Range of Motion in 5th Metacarpal Fracture: A Randomized Controlled Trial

McMaster University1 个研究点 分布在 1 个国家开始时间: 2015年5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
试验地点
1
主要终点
Hand function as measured by validated scoring - the Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure

研究概览

简要总结

Fractures of the fifth metacarpal neck are the most common injury involving the upper extremity. Patients are typically young adult males. Restoring function quickly and reliably for return to work and/or activity is important; these patients are a significant labour force demographic. Treatment is historically splinting for approximately 3-4 weeks. Splinting a fracture is a "trade-off". Immobilization allows stabilization and fracture healing, but also causes hand stiffness and weakness leading to impaired function. Little prospective research exists; there is no agreement for ideal duration of splinting or therapy, demonstrating clinical equipoise. A new concept in hand rehabilitation is "early active range of motion" (EAROM). The objective of this trial is to establish if EAROM provides improved early (6 week) hand function when compared to standard immobilization.

详细描述

Fractures of the fifth metacarpal neck ("boxer's fractures"), are the most common injury to the upper extremity. They are the result of axial force on a flexed metacarpalphalangeal (MCP) joint. Typically, they are caused by striking a hard object with a closed fist, breaking the knuckle on the "little" finger. Restoring hand function quickly and reliably for return to work and/or activity is of utmost importance. These patients are a significant labour force demographic. Since the injury is not characteristically sustained at work, "return-to-work"is an important patient consideration for lost wages. Treatment for fractures of the fifth metacarpal neck is typically non-operative. In the absence of urgent operative indications (ie. "open fractures" or contamination), non-operative management is initiated. Closed reduction is performed with local anaesthesia and manual manipulation. A splint is then applied. Repeat x-rays are obtained to determine positioning. If anatomic alignment is stable, no surgery is indicated and the patient remains splinted for 3-4 weeks. "Early active range of motion" (EAROM) refers to actively moving the fractured digit once fracture callus has begun formation at 3 days. In practice, EAROM begins at 3-14 days.It involves controlled, active tendon glide exercises where the patient attempts to move joints in the injured hand. This motion is perpendicular to the fractures pattern, applying a compressive force to the fracture. From basic science models, compressive forces of EAROM improve rate of bone callus differentiation,early healing,fracture angulation and load bearing.This study aims to translate these basic science concepts to practice.

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 (Care Provider)

入排标准

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

入选标准

  • •Age equal or greater than 18 years
  • •Fifth metacarpal neck fracture, 9 or fewer days since injury
  • •Equal or less than 40 degrees of dorsal fracture angulation on lateral x-ray. Angle is measured between the line along the longitudinal axis of the metacarpal shaft and the line from the centre of the metacarpal head to the fracture site.
  • •No angulation or malrotation
  • •No clinical fracture shortening (ie. Inability to extend fifth digit)
  • •Non-operative treatment
  • •Volar or ulnar gutter splint (MCP flexed, IPs extended)

排除标准

  • •Metabolic bone disease
  • •"Open fracture" with soft tissue loss overlying fracture site
  • •Tendon injury
  • •Neurovascular injury
  • •Clinical rotatory malalignment
  • •Fracture shortening demonstrated by "pseudoclawing"
  • •Other fracture in the ipsilateral upper extremity
  • •Any operative indication
  • •Previous fracture to the involved fifth ray

研究组 & 干预措施

Standard Immoblization

Active Comparator

Standard immobilization with plaster splint for 21-27 following hand fracture

干预措施: Standard Immobilization (Behavioral)

Early Active Range of Motion

Experimental

Early Active Range of Motion (EAROM) 3-9 days following hand fracture

干预措施: Early Active Range of Motion (Behavioral)

结局指标

主要结局

Hand function as measured by validated scoring - the Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure

时间窗: 6 weeks

次要结局

  • HR-QOL(3, 6 and 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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