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临床试验/NCT05264675
NCT05264675招募中不适用

Functional Outcome After Suture or EIP-transfer in EPL-rupture After Distal Radius Fracture

Vastra Gotaland Region1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
range of motion

研究概览

简要总结

Rupture of the extensor pollicis longus, (EPL) is a common complication after distal radius fractures. A rupture prevents the thumb extension, which in turn has a negative impact on hand function. An EPL-rupture can either be surgically treated by primary suture, which means that the ends of the tendon are sutured. This is however not recommended if the tendon is weakened. In such cases the rupture can be treated by a transfer of, most often, extensor indicis proprius (EIP) to the thumb.

Distal radius fractures are common and a rupture of the EPL-tendon is a known complication thar interferes with hand function and therefore more studies on this patient group are warranted.

The aim of this prospective study is to compare regaining of thumb function after surgery, with the non-injured side, after primary suture and EIP-transfer after EPL-rupture as a complication following distal radius fracture.

详细描述

Rupture of the long extensor tendon of the thumb (extensor pollicis longus, EPL) is a common complication after distal radius fracture. The incidence has been shown to be about 1% after surgical treatment of the fracture and up to 5% after non-surgical treatment.

The reason why the tendon ruptures after minimally displaced fractures may be reduced blood flow to the tendon. After surgical treatment of a fracture, the cause of rupture may be irritation of the tendon caused by the osteosynthesis material. A rupture means that the thumb cannot be extended, which affects the function of the hand negatively.

EPL rupture can either be operated with primary suture, which means that the ends of the tendon are found and sutured, however this is not recommended if the tendon is weakened, for example due to poor vascularisation. In such a case, the EPL rupture can be repaired by moving a tendon, (usually the extensor indicis proprius, EIP), to the thumb .

Previous studies focusing on function after EPL rupture have been small and have not differentiated EPL ruptures with different underlying causes and the regimen of post-operative care has not been uniform.

Since distal radius fracture is a very common injury and rupture of the EPL tendon is a known complication that affects hand function, it is important that more studies are done on this patient group. Function should be evaluated both with objective and patient-related outcome measures. Knowledge of function after surgery is important for patients, surgeons and rehabilitation staff.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • comorbidity interfering with thumb function
  • inability to fill in forms

结局指标

主要结局

range of motion

时间窗: 6 months postoperatively

extension, flexion, abduction, retroposition of thumb

次要结局

  • strength(6 months postoperatively)

研究者

发起方
Vastra Gotaland Region
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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