The Influence of Local Bone Status on Complications After Surgical Treatment of Proximal Humerus Fractures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 148
- 试验地点
- 10
- 主要终点
- Local bone quality-related complication
研究概览
简要总结
The purpose of this study is to evaluate if poor bone quality increases the risk of specific types of treatment complications in patients with proximal humerus fractures treated with open reduction and angle-stable plates (Proximal Humeral Internal Locking System - PHILOS).
详细描述
More than 70% of patients with a proximal humerus fracture are older than 60 years, up to three quarters are women and the incidence of low-energy fractures increases exponentially with age. The standard diagnostic method for classifying osteoporosis is the measurement of Bone Mineral Density at specific body sites - hip, vertebra or distal radius. Despite the fact that osteoporotic fractures are very frequent at the shoulder, no study investigated the correlation between local bone quality and fracture treatment at the proximal humerus.
There is a concern among the clinicians that osteoporotic bone in proximal humerus fractures increases the risk of treatment complications. However, to our knowledge this has not yet been evaluated in clinical studies. One major reason for this lack of studies is the fact that no standardized method exists for the determination of bone density at the proximal humerus.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Radiologically confirmed closed fracture (within 10 days) of the proximal humerus
- •All dislocated (mod. Neer) proximal humerus fractures except dislocated fractures of the greater and lesser tuberosity
- •Primary fracture treatment with a PHILOS-plate
- •Age equal greater than 50 and equal younger than 90 years
- •Normal function of both shoulders (pre-trauma) according to age
- •Monotrauma
- •Willing and able to give written informed consent to participate in the study
- •Willing and able to participate in the study follow-ups according to the CIP
- •Willing and able to comply with the postoperative management program
- •Able to understand and read country national language
排除标准
- •Open proximal humerus fractures
- •Concomitant contralateral proximal humerus fracture
- •Previous proximal humerus fracture on either side after the age of 25
- •Time to operation > 10 days
- •Polytrauma
- •Cuff-arthropathy of the contralateral proximal humerus
- •Associated nerve or vessel injury
- •Regular systemic therapy with corticosteroids due to chronic disease
- •Legal incompetence
- •Patient received radio- or chemotherapy prior to, during or within the last year
- •Currently active cancer
- •Recent history of substance abuse (i.e. recreational drugs, alcohol)
- •Currently involved in a pharmaceutical clinical study§
- •Has a disease process that would preclude accurate evaluation (e.g. neuromuscular or rheumatic disease, significant psychiatric or metabolic disorders)
- •Simultaneous participation in another orthopedic/surgical study with the same or another fracture has to be approved by the AOCID.
结局指标
主要结局
Local bone quality-related complication
时间窗: From enrollment to 12 months postoperative
The qualifying events are those involving either directly the local bone and fracture or the implant and its surgical application whether they are anticipated or not.
次要结局
- Occurence of any complication(Baseline)
- Range of motion(at 12 month follow-up)
- Constant-Murley Score(12 months)
- Patient self-assessment of shoulder function - SPADI(3 months)
- Patient self-assessment of shoulder function with the SPADI(12 months)
- Disability of the shoulder and hand - DASH(Baseline)
- Patient self-assessment of upper extremity function with the DASH(12 months)
- Health-related quality of life - EuroQoL5(Baseline)
- Bone mineral density at the distal radius by DXA(until 6 week postoperative)
- EuroQoL5(12 months)
- Validation of a Computed Tomography (CT)-based method for BMD-measurement at the proximal humerus(preoperative)
- Association between the BMD at the proximal humerus (measured by CT) and the BMD at the distal radius (measured by DXA)(until 6 weeks postoperative)