Comparison of Surgical Fixation and Non-Operative Management Outcomes in Proximal Humerus Fractures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Kinesiophobia
研究概览
简要总结
The management of proximal humerus fractures (PHFs) remains a significant challenge in orthopaedics. The acute treatment options for PHFs are numerous and are typically guided by the fracture pattern and functional demands of the patients. The most commonly used methods include non-operative management with a sling or surgical fixation. Although non-surgical treatment is a reasonable treatment option for the majority of humerus fractures, there is an increasing interest in surgical intervention. There are no evidence-based treatment recommendations, thus permitting large local variation in treatment preferences.
There are a number of studies in the literature about how outcome measures of the patients after PHFs management change, but these results generally compare functional results before and after treatment. Misra et al. stated that conservatively managed patients with PHFs have more pain and a poorer range of motion than those managed by either fixation or arthroplasty, while cochrane review stated that surgery is not superior to nonsurgical treatment in most proximal humerus fractures. Jayakumar et al. determined that kinesiophobia is one of the strongest predictors of functional limitation and recovery from a PHF is enhanced by overcoming fears of movement or reinjury within a week after injury.
There is no clear knowledge regarding how the surgical or conservative management used in the management of PHF affects the early results of assessment parameters. The aim of this study was to compare early results of surgical fixation versus non-operative management outcomes in patients with proximal humerus fractures.
详细描述
Voluntary patients who have been diagnosed with proximal humerus fracture and managed by surgical or conservative will be included in the study.
Patients with stabilization after proximal humerus fracture with surgical fixation will be considered as the Surgery group, and patients treated with non-surgical treatment with sling immobilization will be considered as the Conservative group. Signed voluntary consent will be obtained from participants. Patients having surgical fixation or nonoperative management will be assessed for kinesiophobia, pain, range of motion, functional status, and quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- 否
入选标准
- •Stabilization after proximal humerus fracture with surgical fixation (post-op 3-6 weeks) or non-surgical treatment with sling immobilization (callus formation on radiography).
- •Volunteer
排除标准
- •Malunion tubercle majus,
- •Advanced osteoporosis,
- •Avascular necrosis of the humeral head,
- •Presence of neurological and rheumatologic disease,
- •Recurrent infection and open wound-incision in the region,
- •Communication problems
结局指标
主要结局
Kinesiophobia
时间窗: Baseline
Tampa kinesiophobia scale will be used for determining of kinesiophobia or fear of movement.The Tampa Scale for Kinesiophobia is a 17 item questionnaire used to assess the subjective rating of kinesiophobia or fear of movement. The score varies between 17 and high scores indicate an increasing degree of kinesiophobia.
次要结局
- Quality of Life of the patients(Baseline)
- Shoulder Pain(Baseline)
- Range of Motion(Baseline)
- Functional Status(Baseline)
研究者
Ayse Zengin Alpozgen
Assistant Prof.
Istanbul University - Cerrahpasa (IUC)