跳至主要内容
临床试验/NCT01016197
NCT01016197撤回不适用

Surgical Versus Conservative Treatment of Acute Mallet Fingers; a Randomised Controlled Trial

Mid Cheshire Hospitals NHS Foundation Trust1 个研究点 分布在 1 个国家开始时间: 2010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
状态
撤回
试验地点
1
主要终点
DASH score

研究概览

简要总结

The investigators are investigating if surgical treatment of injuries to the tendon which straightens the finger tip gives a better functional outcome than treatment with a splint while the tendon heals.

详细描述

The investigators will randomise patients to receive splinting of their finger while their tendon heals or have surgical intervention. Surgical intervention will entail fixing the tendon with bone anchors and splinting. Conservative treament involves splinting while the tendon heals. We will then monitor the functional outcome of the hand using the DASH questionare over 18 months.

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
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •soft tissue mallet finger
  • •acute injury

排除标准

  • •ASA 3 or above
  • •Unable to give informed consent
  • •Infection in digit affected

研究组 & 干预措施

Conservative

Active Comparator

Four weeks of splinting followed by mobilisation.

干预措施: Mallet splint for 4 weeks (Procedure)

Surgery

Experimental

Surgical repair of the tendon with a bone anchor followed by four weeks of splinting and then mobilisation.

干预措施: extensor tendon repair (Procedure)

结局指标

主要结局

DASH score

时间窗: up to 18 months

次要结局

  • Range of movement at distal interphalyngeal joint.(3, 6, 12 and 18 months)

研究者

申办方类型
Other Gov

研究点 (1)

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