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临床试验/NCT02030496
NCT02030496已完成不适用

Volar Internal Plate Fixation vs. Plaster in Extra- Articular Distal Radial Fractures

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2013年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
2
主要终点
Wrist function/pain/disability at one year assessed with DASH score

研究概览

简要总结

BACKGROUND:

Fractures of the distal radius are common and account for an estimated 17% of all fractures diagnosed. Two-thirds of these fractures are displaced and require reduction. Although distal radius fractures are considered to be relatively harmless, inadequate treatment may result in impaired function of the wrist. The consequences of post-traumatic loss of function are comprehensive, both on an individual and a social level, and have long been underestimated. Despite the substantial implications, no evidence-based treatment method yet exists. Good results have been described both in patients treated conservatively and surgically. Nevertheless, 60% of all fractures redislocate after conservative treatment at which point surgical reduction and fixation is the treatment of choice. Recently, the use of volar locking plates has become more popular. This type of osteosynthesis employs a volar approach to the wrist and provides immediate stable fixation of the reduced fracture. This stability allows for early mobilisation and may therefore result in an improved regain of function. The aim of this study is to compare the functional outcome following surgical reduction and fixation with a volar locking plate with the functional outcome following closed reduction and plaster immobilisation at one year follow-up in patients with displaced extra-articular distal radius fractures.

DESIGN:

This single blinded randomised controlled trial will randomise between open reduction and internal fixation with a volar locking plate (intervention group) and closed reduction followed by plaster immobilisation (control group). The study population will consist of all consecutive adult patients who are diagnosed with a displaced extra-articular distal radius fracture which has been adequately reduced at the Emergency Department. The primary outcome (functional outcome) will be assessed by means of the Disability Arm Shoulder Hand Score (DASH). Since the treatment allocated involves a surgical procedure, randomisation status will not be blinded. However, the researcher assessing the outcome at one year will be unaware of the treatment allocation. In total, 90 patients will be included in this trial which will be conducted in the Academic Medical Centre Amsterdam and its partners of the regional trauma care network.

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
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients ≥ 18 years and ≤ 75 years
  • Extra-articular (AO type A) displaced distal radius fracture, as classified on lateral, posterior anterior and lateral carporadial radiographs by a radiologist or trauma surgeon.
  • Acceptable closed reduction obtained according to current Dutch guidelines within 12 hours after presentation at the Emergency Department (ED).

排除标准

  • Open distal radius fractures
  • Multiple trauma patients (Injury Severity Score (ISS) ≥16)
  • Other fractures of the affected extremity
  • Patients with impaired wrist function prior to injury due to arthritis/neurological disorders of the upper limb
  • Patient suffering from disorders of bone metabolism, connective tissue or (joint) hyperflexibility.
  • Insufficient comprehension of the Dutch language to understand the treatment information and informed consent forms as judged by the attending physician.

研究组 & 干预措施

Closed reduction and plaster

Active Comparator

Closed reduction will be performed and after adequate reduction has been confirmed, the wrist will be immobilised according to Dutch guidelines: a splint for one week followed by a circular cast for another four weeks.

干预措施: Closed reduction and plaster (Other)

open reduction and internal fixation

Active Comparator

The intervention group will be treated with open reduction and internal fixation with a volar locking plate.

干预措施: open reduction and internal fixation (Procedure)

结局指标

主要结局

Wrist function/pain/disability at one year assessed with DASH score

时间窗: At12 months follow up

the primary endpoint of this study is wrist function, pain and disability as measured with the DASH score. The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item, self-report questionnaire designed to measure physical function and symptoms in patients with any or several musculoskeletal disorders of the upper limb.

次要结局

  • Wrist function at one year assessed with PRWE score(6 weeks, three, six and 12 months)
  • Complications(1 week, 2-3 weeks, 6 weeks, 3, 6 and 12 months)
  • Quality of Life(6 weeks, three, six and 12 months)
  • Patient satisfaction(at one year)
  • Range of motion(6 weeks, 3, 6 and 12 months)
  • Grip strength(6 weeks, 3, 6 and 12 months)
  • Radiological parameters(At one year)
  • Pain(6 weeks, 3, 6 and 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

J.C. Goslings

Prof, PhD

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

研究点 (2)

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