NCT00872105已完成不适用
A Multicentre, Randomized Trial of Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Distal Clavicle
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- The primary outcome measurement will be patient DASH (Disabilities of the Arm, Shoulder and Hand Instrument) scores. The DASH is a patient-oriented, limb-specific, functional measurement questionnaire.
研究概览
简要总结
This is a multicentre randomized clinical trial prospectively comparing operative treatment versus conservative (nonoperative) care in the management of displaced distal (Type II) clavicle fractures.
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
- •Completely displaced (no cortical contact), closed fracture of the distal 3rd of the clavicle (Type II) confirmed by radiograph
- •Fractures within 28 days post injury
- •Provision of informed consent
排除标准
- •Pathological fractures
- •Non-displaced (cortical contact) distal clavicle fractures
- •Open clavicle fractures
- •Presence of vascular injury
- •Fractures more than 28 days post-injury
- •Limited life expectancy due to significant medical co-morbidity
- •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 measurement will be patient DASH (Disabilities of the Arm, Shoulder and Hand Instrument) scores. The DASH is a patient-oriented, limb-specific, functional measurement questionnaire.
时间窗: 2 years
次要结局
- The secondary outcome measurement patients' functional shoulder scores as defined by Constant's Shoulder Score (i.e. pain, activities of daily living, range of motion and power).(2 years)
研究者
研究点 (2)
Loading locations...
相似试验
招募中
不适用
Conservative Treatment of Early Adhesive CapsulitisAdhesive CapsulitisNCT06041282Second Affiliated Hospital, School of Medicine, Zhejiang University300
已完成
不适用
Conservative or Operative Treatment of Fractures in the Neck of the 5th Metacarpal BoneFractures of the NeckNCT01139528Oslo University Hospital85
Unknown
不适用
Patella Fracture : A Randomized Controlled TrialPatella FractureAgingNCT03445819Unity Health Toronto84
Unknown
3 期
Different Surgical Approaches in Patients of Early-stage Cervical CancerUterine Cervical NeoplasmLaparotomyLaparoscopySurvivalMortalityMorbidityQuality of LifePelvic Floor DisordersCost-Benefit AnalysisNCT03739944Lei Li700
招募中
不适用
Study Comparing SBS and LRTI for Treatment of CMC ArthritisArthritisNCT05111405Fraser Orthopaedic Research Society138