NCT01984112已完成不适用
Proximal Humerus Fractures: Randomized Study Between Intramedullary Locking Nails and Locking Plates for Neer 2 and 3 Parts Displaced Fractures
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Shoulder function, pain, strength and range of motion, measured by Constant-Murley Score
研究概览
简要总结
The hypothesis of this study is to determine whether the technique of intramedullary locking nail presents clinical results comparable to the technique of locking plates, based on the Constant Score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fracture with less than 21 days;
- •Fractures of the proximal humerus classified as 2 or 3 parts of Neer, with involvement of the humeral head and one of the tuberosities;
- •Fracture with unacceptable deviation for the non-surgical treatment, according to the criteria of Neer Neer: fractures with deviation greater than 45 ° or 1 cm for the fragment of the humeral head and fractures with a deviation of the tuberosity greater than 0.5 cm;
- •Closed fractures;
排除标准
- •Characteristics of the fracture:
- •fracture between the greater tubercle and the smaller, independent of the deviation;
- •Isolated fracture of the greater or lesser tuberosity
- •4-part fractures of Neer;
- •Fracture involving the articular surface of the humeral head;
- •Fracture-dislocation of the proximal humerus
- •Other criteria:
- •Neurological injuries in the affected limb;
- •previous surgery on the affected shoulder;
- •associated fractures in the affected limb;
- •pathologic fractures;
- •lesions of the rotator cuff tendons previously diagnosed;
- •Psychiatric illnesses or inability to understand preoperative questionnaires;
- •Active infection or previous infection on the shoulder;
研究组 & 干预措施
Intramedullary Locked Nail
Experimental
干预措施: Intramedullary locked nail (Device)
Locked Plate
Active Comparator
干预措施: Locked plate (Device)
结局指标
主要结局
Shoulder function, pain, strength and range of motion, measured by Constant-Murley Score
时间窗: 12 months
Absolute Constant-Murley Score, that measures: Shoulder function, pain, strength and range of motion 0-100 points score 12 months as the final outcome
次要结局
- Number of patients with complications(12 months)
- Superior limb function, measured by DASH score(12 months)
- Shoulder function, pain, strength, range of motion and satisfaction with treatment, measured by UCLA score(12 months)
- Shoulder function, pain, strength and range of motion compared with non-injuried shoulder, measured by Individual Relative Constant-Murley Score(12 months)
研究者
Mauro Gracitelli
MD
University of Sao Paulo
研究点 (2)
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