Prospective Case Series to Assess the Handling, Healing and Complications of Using a Titanium Small Fragment Plating System With a New Shape Specifically Adapted to the Distal Ulna
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 主要终点
- Complicationsrate
研究概览
简要总结
Background of the study:
Various studies show that the outcome of unstable distal ulna fractures after open reduction and internal fixation is better than closed reduction. The previous plate system for the distal ulna fractures is applied exclusively on the extensor side. This often leads to irritation of the extensor tendons, as well as problems with pronation and supination. With the new shape of the angle-stable distal ulna plate, the investigator hopes that the stability of the fracture osteosynthesis will remain the same and that it will be better tolerated with regard to the surrounding soft tissue, especially the extensor tendons. In this way, an otherwise practically unavoidable removal of osteosynthesis material could - at least in some cases - be avoided and some patients spared a follow-up operation.
With this in mind, the investigator tries to achieve the greatest possible reconstruction and stability for early functional follow-up treatment with a slightly bulky implant placed in the tendon-free area.
详细描述
With this study, the application and usability of the new angle-stable plate system should be determined and documented.
New value of the study:
This system enables an optimal position of the plate on the distal ulna, on the one hand due to the position on the flexor side and on the other hand due to the new shape, adapted to the anatomy of the distal ulna. The locking system using angle-stable screws corresponds to the systems previously used by I.T.S.
Design:
Prospectively, handling, advantages and possible complications of the angle-stable, distal ulna plate; Company I.T.S. in the osteosynthesis of the unstable distal ulna fracture. A total of 20 patients with unstable distal ulna fractures are to be treated and evaluated over a period of 12 months according to the study design.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years
- •unstable distal ulna fractures
- •Fracture classification according to Biyani [4]: all types
排除标准
- •Age under 18 years old
- •stable fractures of the ulna
- •Patient had one before ulna fracture
- •Patient may result in physical or intellectual disability consent not grant
- •Patient is for more Check-ups not available (Abroad)
- •Patient does not have full legal capacity
- •Alcohol and drug abuse
- •Increased risk of anesthesia (from ASA 3)
结局指标
主要结局
Complicationsrate
时间窗: 1 year
Percentage of complications rate of patients treated with DUL
次要结局
- Clinical outcome (range of motion)(1year)
- Clinical outcome (grip strength wrist)(1year)
- Patient Reported Outcome (function)(1 year)
- Patient Reported Outcome (pain)(1 year)
