Double Plating Versus Single Plating Techniques in Midshaft Clavicle Fractures
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 336
- 主要终点
- Number of surgical re-interventions
研究概览
简要总结
The goal of this mutlicenter quasi-randomized observational cohort study is to compare single vs double plating in patients with a midshaft clavicle fracture. The main question it aims to answer is:
- Does low profile double plating of midshaft clavicle fractures with one 2.0mm plate and a second 2.4 or 2.7 mm plate lead to a lower rate of re-intervention when compared to either single superior or single anterior plating?
详细描述
Clavicle fractures account for 2% to 5% of all fractures in adults, with a majority of patients being young and active. A gold standard for the treatment of clavicle fractures has yet to be established, but single plated surgical intervention is most widely used. In recent years a smaller double plating technique has been described as a possible solution to the high removal rates associated with single plating. In (orthopaedic) surgery however, randomized controlled trials (RCTs) are recognized for their limitations. Although RCTs are considered the gold standard for testing the efficacy of new interventions, randomisation and blinding can be challenging. Simultaneously, there is an inclination for the usage of RCTs in clinical protocols, frequently based on the credo that it is the only valid method of comparing treatments. A natural experiment (NE), or quasi-experiments, in which groups are compared by nature of factors outside the control of the investigator (i.e. different surgical techniques between centres), offers a possible solution for methodological quality control. This study aims to increase the knowledge on surgical outcomes for single vs double plating in midshaft clavicle fractures following a natural experiment design.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years and older
- •Primary mid-shaft clavicula fracture defined as the middle third of the clavicle (Robinson Type II or AO 15.2)
- •Patients that are eligible for operative treatment of clavicle fractures.
- •Generally accepted indications include:
- •Displacement of one or more shaft width
- •Shortening of more than 1cm in length
- •High demand patients (physical activity)
排除标准
- •Delayed presentation (> 14 days)
- •Initial operative treatment at non-participating hospitals
- •Open fractures
- •Pathological fractures
- •Re-fractures of clavicle
- •Concomitant ipsilateral injury of upper extremity (including but not limited to shoulder, scapula, and ribs)
- •Cognitive impairment or language barrier precluding answering questionnaires
- •Unable to complete follow-up (e.g. different residential area/tourists)
结局指标
主要结局
Number of surgical re-interventions
时间窗: 2 years follow-up
Any type of re-intervention (i.e. plate removal, screw adjustment etc.)
次要结局
- Fracture realted infections(2 years follow-up)
- Symptomatic non union(1 year follow-up)
- Asymptomatic non-union(1 year follow-up)
- Numbness below scar line(1 year follow-up)
- Self-reported implant irritation/implant prominence(1 year follow-up)
- Operative time(Baseline)
- Length of surgical incision(basline)
- DASH score(baseline, 3- and 12-monts follow-up)
- EQ-5D(baseline (pre-injury), 3- and 12-months follow-up)
- VAS pain score(3- and 12-months follow-up)
- VAS for patient satisfaction(3- and 12-months follow-up)
- Number of surgical re-interventions(1 year follow-up)