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临床试验/NCT04323410
NCT04323410招募中不适用

Casting in Finger-trap Traction Without Reduction Versus Closed Reduction and Percutaneous Pin Fixation of Dorsally Displaced, Overriding Distal Metaphyseal Radius Fractures in Under Eleven Years Old Children

Töölö Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年6月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Wrist ROM

研究概览

简要总结

This is a randomized controlled trial comparing casting in finger-trap traction without reduction versus closed reduction and percutaneous pin fixation of dorsally displaced, overriding distal metaphyseal radius fractures in under eleven years old children.

详细描述

Overriding pediatric distal radius fractures have been managed with anatomical reduction performed under anesthesia with or without percutaneous pinning. This research protocol was developed due to good results reported on leaving the fractures in an overriding position.

In this randomized controlled trial, we will compare objective outcomes between casting in finger-trap traction without reduction versus closed reduction and percutaneous pin fixation of dorsally displaced, overriding distal metaphyseal radius fractures in children.

Inclusion criteria are patients younger than 11 years old (Tanner 0) with completely overriding distal radius fractures. At the emergency department patients are randomized into two groups: finger trap traction and cast immobilization (experimental group) and anatomic reduction and percutaneous pin fixation (control group).

The current controversy is whether cast immobilization alone is an adequate stabilization or whether percutaneous pin fixation is more appropriate for displaced, complete, distal forearm (overriding) metaphyseal fractures. The objectives of this trial are to compare the outcomes between conservative treatment with finger trap method for completely displaced distal radius fractures and surgical treatment with percutaneous pinning. Our null hypothesis is that there are no radiological or clinically relevant differences in outcome measures between the two treatment groups. We consider non-inferiority proven if there is no clinically significant difference at 6 months between the two treatments groups in the primary outcome: ratio (%) of forearm rotation and wrist extension-flexion range of motion (ROM) compared to the non-affected side at 6 months (non-inferiority margin 10%).

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
— 至 10 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Child with open epiphysis with closed overriding metaphyseal distal radial fracture with or without an associated fracture of the ulna
  • •Normal communication development (languages Finnish, Swedish, English)

排除标准

  • •Bilateral forearm injuries
  • •Gustillo-Anderson grade II or III open fracture
  • •Galeazzi fracture-dislocation
  • •Polytrauma
  • •Neurovascular injury of the ipsilateral upper extremity
  • •History of a displaced forearm fracture
  • •Underlying disease affecting fracture healing

研究组 & 干预措施

Cast immobilization

Experimental

In the casting group, padded synthetic dorsal above elbow and volar below elbow splints are applied in ED without local or general anesthesia. Dorsal displacement and shortening of the radius are not corrected, but the forearm is attempted to be manipulated straight during application of the splints. The casted forearm is then supported by a collar and cuff sling. Splints are removed in an outpatient clinic at 4 weeks.

Cast immobilization is discontinued after 4 weeks and when the fracture site is nontender. If palpated tenderness is still present, the patient is given a dorsal forearm splint which can be removed (maximum of 2 weeks usage).

干预措施: Cast immobilization (Procedure)

Percutaneus pinning

Active Comparator

In the surgery group, a padded dorsal above elbow splint is applied in ED. Reduction and percutaneous pinning are performed under anesthesia in operating room by an experienced attending pediatric orthopedic surgeon within 7 days from the injury. Pin fixation is performed with two 1.6 mm pins. Padded dorsal above elbow and volar below elbow splints are applied. Splints and pins are removed at the outpatient clinic at 4 weeks after surgery.

干预措施: Percutaneus pinning (Procedure)

结局指标

主要结局

Wrist ROM

时间窗: 6 months

The ratio (injured side/non-injured side) in total active range of motion of the wrist in the flexion-extension plane.

Forearm ROM

时间窗: 6 months

The ratio (injured side/non-injured side) in the total active forearm rotation.

次要结局

  • Forearm ROM(3 months, 1 year)
  • Wrist ROM(3 months, 1 year)
  • Grip strength(3 and 6 months, 1 year)
  • Patient-reported pain(1 and 4 weeks, 3 and 6 months, 1 year)
  • Overall satisfaction(6 months)
  • Patient-reported outcome (PROM)(4 weeks, 3 and 6 months, 1 year)
  • Radiographic outcomes(1 and 4 weeks, 3 and 6 months, 1 year)
  • Forearms length(3 and 6 months, 1 year)

研究者

发起方
Töölö Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Topi Laaksonen

Principal Investigator

Helsinki University Central Hospital

研究点 (1)

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