Evaluation of the Functional Outcomes of Surgical Treatment in Displaced, Closed, and Isolated Distal Clavicle Fractures in Adults, A Comparative Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- The Rate of wire migration
研究概览
简要总结
Clavicle fractures are common among young people, generally as a consequence of car accidents, bike falls, and contact sports injuries. 15-20% of all clavicle fractures involve the lateral end of the bone. Thus, the distal clavicle fractures, in particular, have a high nonunion rate ranging from 21-33% when treated non-operatively, underscoring the usual advice for operative treatment. While significant research has been conducted on clavicle fractures and their treatment options, no definitive guidelines or optimal approaches have been established. Hence, this study aimed at assessing the clinical and radiological results of the two highly used surgical techniques, the Tension Band Wiring (TBW) and Hook plate ones, in addition to investigating the associated functional recovery and outcomes.
详细描述
Clavicle fractures are common among young people, generally as a consequence of car accidents, bike falls, and contact sports injuries. 15-20% of all clavicle fractures involve the lateral end of the bone. Thus, the distal clavicle fractures, in particular, have a high nonunion rate ranging from 21-33% when treated non-operatively, underscoring the usual advice for operative treatment. While significant research has been conducted on clavicle fractures and their treatment options, no definitive guidelines or optimal approaches have been established. Hence, this study aimed to assess the clinical and radiological results of the two highly used surgical techniques, Tension Band Wiring (TBW) and Hook plate ones, in addition to investigating the associated functional recovery and outcomes.
Between August 2019 and 2022, An analytical retrospective comparative study was done on 38 patients (20 TBW and 18 Hook plate) diagnosed with a fracture of the lateral third of clavicle (Neer 2) and followed up for more than 12 months at Tishreen University Hospital, Lattakia, Syria.
This research study included patients who met the following criteria: Patients with unstable distal third clavicle fracture (Neer type 2), aged between 18 and 65 years old. Nevertheless, Patients who had open fractures, pathological fractures, fractures associated with brachial plexus or pulmonary or vascular injury, acromioclavicular joint disruption, and musculoskeletal disease that affects the joint, were excluded.
Preoperative shoulder x-rays in AP with (10-15) ° cephalic tilt (ZANCA View) and axillary view were taken. In addition, Basic lab tests were done for all patients on admission. this study used A.O Hook plate with (4-7) holes, (3.5) mm screws, and (12.15.18) mm of hook depth, 2 Kirschner-wires of (2.0) mm, and a stainless steel wire of (18) gauge in the TBW technique.
Furthermore, Radiological assessment was performed immediately after surgery, followed by evaluations at 3, 6, 12, and 24-week intervals to monitor healing progress and implant positioning. Recorded complications included infection, non-union, mal-union, pin migration, hardware impingement, and stiffness. The outcome was assessed based on union status, time to fracture union, shoulder joint range of motion, ability to perform daily activities and return to pre-injury status
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with unstable distal third clavicle fracture (Neer type 2)
- •Patients aged between 18 and 65 years old
排除标准
- •Patient who had open fractures, pathological fractures, fractures associated with brachial plexus or pulmonary or vascular injury, acromioclavicular joint disruption, and musculoskeletal disease that affects the joint
结局指标
主要结局
The Rate of wire migration
时间窗: Up to 12 months, Regular monitoring of wire stability and migration during scheduled follow-up visits, typically conducted monthly for the duration of the study.
The rate of wire migration refers to the occurrence of movement or displacement of wires used in surgical procedures, particularly those intended for fixation or support, Wire migration can lead to various complications depending on the location and purpose of the wire, including malpositioning, tissue damage, or loss of efficacy in providing support or stabilization.
The incidence of sub-acromial impingement
时间窗: Continued monitoring of shoulder function and pain at intermediate time points during the study, up to 12 months post-treatment,
Sub-acromial impingement syndrome is a common shoulder disorder characterized by compression or irritation of the structures located beneath the acromion, including the rotator cuff tendons and sub-acromial bursa.
The Rate of Skin erosion
时间窗: Continued monitoring immediate post-intervention period up to 12 months post operatively.
Skin erosion refers to the gradual wearing away or breakdown of the skin surface, leading to the exposure of underlying tissues.skin erosion may occur as a result of various factors, including the type of medical device or implant used, repeated friction or pressure on the skin, or underlying infection. Monitoring skin erosion is important as it can indicate potential complications related to the intervention, such as device failure, tissue irritation, or infection.
The Rate of Wound infection
时间窗: Estimated time is up to 6 weeks, follow-up visits typically at 2 weeks, 4 weeks, and 6 weeks post-surgery.
Wound infection refers to the occurrence of microbial contamination or colonization leading to clinical signs and symptoms of infection at the surgical site. It encompasses various types of infections, including superficial, deep, and organ/space surgical site infections, as defined by the Centers for Disease Control and Prevention (CDC) criteria.
次要结局
未报告次要终点