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临床试验/NCT05315284
NCT05315284Unknown不适用

The Clinical and Radiological Outcomes of the Use of Titanium Elastic Nail in The Fixation of Fresh Non-comminuted Fracture Mid-shaft Clavicle

Sohag University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
2
主要终点
The Clinical Outcome of the Use of Titanium Elastic Nail in The Fixation of Fresh Non-comminuted Fracture Mid-shaft Clavicle

研究概览

简要总结

The Clinical and Radiological Outcomes of the Use of Titanium Elastic Nail in The Fixation of Fresh Non-comminuted Fracture Mid-shaft Clavicle

详细描述

Introduction:

The midshaft clavicle fractures account for 3 to 5% of all injuries and 70 to 80% of all clavicle fractures.[1,2] In young adults, these fractures are usually related to sports or vehicle accidents, whereas in children and elderly, they are usually related to falls.[1,2] In general, clavicle fractures are treated conservatively and have a good outcome. In 1960, Neer reported a non-union rate of 0.1% with conservative treatment[3] and Rowe corroborated these findings in 1968 and showed a nonunion rate of 0.8% in conservatively managed patients.[4] Since then, however, other authors have failed to demonstrate similar good results with conservative treatment.[5,6] This may be due to the fact that the initial series included children and adolescents and their enormous potential for bone healing may have skewed the results, and that patient-based scoring systems were not used in the initial series to record the outcome.[7] Hill et al. showed that displacement of more than 20 mm resulted in 15% non-union and 18% of the patients had thoracic outlet syndrome following union.[5] McKee et al. noted reduced patient satisfaction due to asymmetry and cosmesis following malunion in patients with more than 20 mm shortening.[6] Hence, more recently, there has been a trend toward surgical fixation.

Surgery has been indicated for completely displaced fractures, potential skin perforation, shortening of clavicle by more than 20 mm, neurovascular injury, and floating injury.[8] The gold standard for the surgical treatment has been open reduction and plate fixation through a large incision.[8] Other surgical options include intramedullary pinning with Kirschner wire, Rush pins, Knolwes pin, Steinman pin, Haige pin, ESIN (elastic stable intramedullary nailing), and external fixation.[9] Intramedullary fixation for clavicular fractures was first described by Peroni in 1950.[10] A systematic review showed relative risk reduction of 72% and 57% for non-union when using intramedullary fixation and plate fixation, respectively, when compared with non-operative treatment of midshaft clavicle fractures.[11] Intramedullary devices behave as internal splints that maintain alignment without rigid fixation. The use of an intramedullary device carries advantages of a smaller incision, less soft tissue dissection, load sharing fixation with relative stability that encourages copious callus formation.[12] The titanium ESIN has been successfully used in fixation of pediatric long bone fractures. One advantage of the titanium ESIN is that it can block itself in the bone and provide a three-point fixation within the Sshaped clavicle.[8,13] However, some studies have shown a relatively high complication rate and technical difficulties with intramedullary nailing.[7,8] The aim of this study was to investigate the union rate and complication rate of our patients with displaced midshaft clavicle fractures treated with titanium ESIN. Aim of the study Investigating the union rate and complications rate following titanium elastic stable intramedullary nailing (ESIN) for midshaft non-comminuted clavicle fractures with >20 mm shortening/displacement. Materials and methods Place of the study: Orthopaedics and Traumatology Department, Sohag University Hospital. Type of the study: Prospective study. Study period: from December,2021 till December,2022. Inclusion criteria: (1) Type IIA2 (angulation > 45 ) or IIB1 (shortening or overlapping displacement length > 2 cm) fresh unilateral midshaft clavicular fractures according to Robinson classification. (2) Patient without underlying diseases such as primary hypertension and cardiac diseases. Exclusion criteria: (1) pathological fractures. (2) multiple injuries of upper limbs. (3) open fractures. (4) combined with injuries of blood vessels or nerves. (5) other diseases which affected the functions of upper limbs. (6) Proximal and distal clavicular fractures. (7) Comminuted clavicular fractures. Preoperative assessment: (1) Clinical evaluation: pain, tenderness, deformity, shortening, skin tethering and loss of function. (2) Radiological assessment: plain X-ray imaging is the corner stone for establishing the diagnoses of clavicular fractures. CT scans can be used to exclude comminuted clavicular fractures if the comminution of the fracture couldn't be visualized by the plain X-ray studies (3) Laboratory assessment: routine laboratory investigations for any surgery.

Standard protocol approvals and patient consents:

This study will be approved by the Medical Research Ethics committee at faculty of medicine, Sohag University. An informed written consent will be obtained from each patient.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • : (1) Type IIA2 (angulation > 45 ) or IIB1 (shortening or overlapping displacement length > 2 cm) fresh unilateral midshaft clavicular fractures according to Robinson classification. (2) Patient without underlying diseases such as primary hypertension and cardiac diseases.

排除标准

  • (1) pathological fractures. (2) multiple injuries of upper limbs. (3) open fractures. (4) combined with injuries of blood vessels or nerves. (5) other diseases which affected the functions of upper limbs. (6) Proximal and distal clavicular fractures. (7) Comminuted clavicular fractures.

结局指标

主要结局

The Clinical Outcome of the Use of Titanium Elastic Nail in The Fixation of Fresh Non-comminuted Fracture Mid-shaft Clavicle

时间窗: 3 months

Investigating the union rate and complications rate following titanium elastic stable intramedullary nailing (ESIN) clinically for midshaft non-comminuted clavicle fractures with \>20 mm shortening/displacement.

The Radiological Outcome of the Use of Titanium Elastic Nail in The Fixation of Fresh Non-comminuted Fracture Mid-shaft Clavicle

时间窗: 3 months

Investigating the union rate and complications rate following titanium elastic stable intramedullary nailing (ESIN) radiologically for midshaft non-comminuted clavicle fractures with \>20 mm shortening/displacement.

次要结局

未报告次要终点

研究者

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

Mostafa Salah Mohamed

Resident Doctor

Sohag University

研究点 (2)

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