Angle Stable Plate Versus Reverse Shoulder Treatment for Proximal Humeral Fractures: Should the Psychological Health Influence the Choice of Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 主要终点
- Change in Constant's score
研究概览
简要总结
It was conducted a prospective study with a series of 63 patients treated with O.R.I.F. (Open Reduction and Internal Fixation) (group A) and with RSA (Reverse Shoulder Arthroplasty) (group B) for three and four-part proximal humeral fractures according to Neer classification system. One independent observer performed clinical and a psychological evaluation at one(T0), six(T1) and twelve months(T2) postoperatively.
The Constant's score and The Disabilities of the Arm, Shoulder and Hand (DASH score) were used for clinical evaluation, while General Anxiety Disorder-7 (GAD-7) and Caregiver Strain Scale (CSS) were used for psychological evaluation.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Three and four-part proximal humeral fractures according to Neer classification system;
- •Patients seventy years or older;
- •Shoulder surgery within one week after trauma
排除标准
- •Exposed fractures;
- •Pathological fractures;
- •Proximal humerus fractures with metaphyseal or diaphyseal extension;
- •Contraindications to surgery associated with organ dysfunctions or with coagulopathy;
- •Allergy or hypersensitivity to the orthopedic implants;
- •Patients who were unable to attend the different follow-ups;
- •Patients with psychiatric disorders
结局指标
主要结局
Change in Constant's score
时间窗: T0 (one-month), T1 (six months), T2 (one year) post operatively
The shoulder functionality was quantified using the Constant's score ranging between 0 (most disability) and 100 points (least disability).
次要结局
未报告次要终点