Reconstruction Plate Compared With Flexible Intramedullary Nailing for Midshaft Clavicular Fractures: a Prospective, Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- DASH score
研究概览
简要总结
The purpose of this study is to compare the clinical and radiographic results of patients with midshaft clavicular fractures treated with plates or intramedullary flexible nails fixation.
详细描述
Midshaft clavicular fractures are classically treated with non-surgical methods, supported by many authors as an effective treatment. However, different researches have shown high rates of nonunion and clavicle malunion related to the nonoperative treatment. Currently, indications for surgical treatment are wider and include mainly the following: shortening greater than or equal to 2.0 cm, multiple trauma, open fractures or with imminent exposure and associated neurovascular injury.
Plate fixation of midshaft clavicular fractures is widely described in the literature, and is considered the gold standard by different authors, associated with a high union rate and a low complication rate. Different types of plates have been used, including reconstruction plates, dynamic compression plates (DCP), low-contact dynamic compression plates (LC-DCP), semi-tubular plates, and pre-molded locking plates. Possible complications are postoperative infection, hardware loosening or failure, peri-incision paresthesia, neurovascular iatrogenic lesions, nonunion, and hardware related symptoms.
Elastic stable intramedullary nailing (ESIN) technique has been used in recent years in the treatment of midshaft clavicular fractures. Different studies report excellent functional results and low complication rates. Some theoretical advantages in relation to plates are the 3-point flexible nail support, which provides superior biomechanics resistance and uses the relative stability principle, favoring callus formation. When compared to plain steel wires, titanium nails have lower migration risk, due to its greater flexibility and better bone fixation.
The purpose of this study is to compare the clinical and radiographic results of patients with midshaft clavicular fractures treated with reconstruction plates or ESIN.
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 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Displaced Fractures of the middle third of the clavicle (no contact between the main fragments)
- •Age between 16 and 65 year old;
- •Terms of consent signed by the patient or guardian.
排除标准
- •Fracture of medial or lateral third of the clavicle;
- •Cortical contact between the main fracture fragments;
- •Age below 16 years old or more than 65 years old;
- •Pathological fracture;
- •Ipsilateral previous injuries of the shoulder or upper limb;
- •Ipsilateral associated fractures of the shoulder or upper limb;
- •Neuro-vascular injury associated;
- •Open fracture not eligible for primary internal fixation;
- •Clinical contraindication for surgery;
- •Fracture older than 30 days;
- •Patient not cooperative or ineligible for the follow-up;
- •Lack of consent to participate.
结局指标
主要结局
DASH score
时间窗: 6 months
Disabilities of the Arm, Shoulder and Hand score (0: best function; 100: worst function)
次要结局
- DASH score(12 months)
- Constant-Murley Score(6 and 12 months PO)
- Time to Union(Monthly)
- Radiographic residual shortening(6 months)
- Patient satisfaction with the treatment(6 and 12 months)
- Complication rate(Monthly)
研究者
Fernando B Andrade-Silva, MD
MD
University of Sao Paulo