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临床试验/NCT00848263
NCT00848263已完成不适用

Unstable Fractures of the Distal Radius: Randomised Controlled Trial of Volar Plate Versus Dorsal Nail Plate Fixation.

Sykehuset Asker og Baerum2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2009年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
2
主要终点
DASH score

研究概览

简要总结

Fractures of the distal radius are one of the most common orthopaedic injuries and are associated with a high complication rate. There is a lack of clinical trials comparing the different treatment modalities of fractures of the distal radius. The purpose of this randomized trial is to assess differences in functional outcome, radiological results, and complication rate in patients 55 years and older with an unstable displaced fracture of the distal radius without articular involvement treated with a dorsal nail plate or a volar plate.

详细描述

Surgical treatment is needed for distal radius fractures that can not be treated with a simple plaster cast, and is indicated in a substantial amount of these patients. There is a well known correlation between a good anatomical result and a good functional outcome for the patient. The most common methods for operative fixation are external fixation with a metal frame, percutaneous pin fixation, and open surgery with insertion of a metal plate and screws on the dorsal or the volar side of the fracture. Biomechanical studies have shown differences in mechanical stability between different plate fixation systems.

The investigators are conducting this randomized trial to investigate the differences in outcome after treatment with a DVR volar plate and a DNP dorsal nail plate. The DVR volar plate follows the same principles of fixation as other volar plates using locking screws and/or pegs. It has smooth or threaded pegs that are multidirectionally placed in the distal part of the plate. The dorsal nail plate (DNP) is a relatively new implant that is inserted through a less invasive technique, with a minimum of soft tissue exposure. It is inserted through a 3-4 cm long incision on the dorsal side of the wrist and is introduced into the medullary canal. It is fixed with screws on the proximal (nail) side of the fracture and threaded or smooth locked multidirectional pegs on the distal (plate) side of the fracture. It has been suggested as a good alternative to regular plate fixation where less invasive surgery is desired. Clinical patient series have been published showing good clinical results.

There are no clinical trials comparing these two types of treatment. Therefore the investigators want to conduct a randomised controlled trial, with the purpose of finding potential differences in functional outcome for the patients.

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 (Outcomes Assessor)

入排标准

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

入选标准

  • Unstable dorsally displaced fracture of the distal radius without articular involvement
  • Age 55 years or older

排除标准

  • Previous fracture of the same wrist
  • More than one acute fracture (except the ulnar styloid process)
  • Open fracture
  • Mental impairment or unable to understand and sign an informed consent
  • Fracture older than 14 days

结局指标

主要结局

DASH score

时间窗: 52 weeks

次要结局

  • EQ-5D score(52 weeks)
  • Radiological result(52 weeks)
  • Pain VAS score (1-10)(52 weeks)
  • Grip strength(52 weeks)
  • PRWE score(52 weeks)

研究者

发起方
Sykehuset Asker og Baerum
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wender Figved

Md PhD

Sykehuset Asker og Baerum

研究点 (2)

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