NCT01051869已完成不适用
A Multicentre, Randomized Trial of Simple Decompression Versus Anterior Transposition of the Ulnar Nerve for Acute, Displaced Fractures of the Distal Humerus Treated With Plate Fixation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- The primary outcome will be signs of ulnar neuropathy, measured using two clinical staging systems to assess the degree of dysfunction of the ulnar nerve (the classification system of Gabel and Amadio13).
研究概览
简要总结
Both simple decompression and anterior transposition of the elbow nerve (ulnar nerve) for acute displaced fractures of the elbow (distal humerus) treated with plate fixation are currently used by surgeons. We want to examine which treatment will overall give better results in regards to arm function and residual pain.
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 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged 16 to 60 years of age
- •Displaced, distal humerus fracture (OTA 13A or 13C) as seen in radiographs
- •Fractures ≤ 28 days post injury
- •Closed fractures
- •No history of previous ulnar neuropathy or elbow pathology
- •Provisin of informed consent
排除标准
- •Vascular injury
- •History of previous ulnar neuropathy or elbow pathology
- •Fractures more than 28 days post-injury
- •Limited life expectancy due to significant medical co-morbidity or medical contraindication to surgery
- •Inability to comply with rehabilitation or form completion
- •Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, patients not mentally competent to give consent, etc.)
结局指标
主要结局
The primary outcome will be signs of ulnar neuropathy, measured using two clinical staging systems to assess the degree of dysfunction of the ulnar nerve (the classification system of Gabel and Amadio13).
时间窗: 1 Year
次要结局
- Secondary outcome measurement will include a patient-oriented, limb-specific, functional measurement questionnaire (Disabilities of the Arm, Shoulder and Hand Instrument-DASH)(1 Year)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Comparing the effectiveness of two treatments for severe cubital tunnel syndromeAdvanced cubital tunnel syndromeNervous System DiseasesISRCTN91919572Third Hospital of Hebei Medical University90
撤回
不适用
Acute Nerve Decompression Versus Non-operative Treatment for Peroneal Nerve Palsy Following Primary Total Knee ArthroplastyPeroneal Palsy (Foot Drop)NCT02856958Rush University Medical Center
已完成
4 期
Randomized Double-Blind Controlled Trial: Comparison outcomes between Conventional open carpal tunnel release and Mini-open carpal tunnel releaseConventional open carpal tunnel releaseMini-open carpal tunnel releasePostoperative painPain scoreBCTQCarpal tunnel syndromeTCTR20230703005/A40
尚未招募
不适用
Peripheral nerve decompression surgery as treatment of secondary headache caused by entrapment neuropathy of extracranial sensory nervesNL-OMON49524Erasmus MC, Universitair Medisch Centrum Rotterdam70
已完成
不适用
Minimal Invasive Carpal Tunnel Release With the Novel DeviceCarpal Tunnel SyndromeNCT05067205Kaohsiung Medical University41