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临床试验/NCT02461680
NCT02461680终止不适用

Management Of The Partial Lesions Of The Fingers Flexor Tendons, Prospective Randomized Trial Of 2 Surgical Procedures: Tangential Resection Versus Direct Suture

University Hospital, Strasbourg, France2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2016年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
3
试验地点
2
主要终点
Total active motion Grasp

研究概览

简要总结

Flexors tendon injuries are frequent and serious with a potential of definitive functional aftereffects. In the case of partial injury, the treatment is debated. There are 2 techniques of possible repair, the direct suture and the tangential resection. The investigators have already demonstrated that this last technique was favorable for injuries going to 50 %. In the case of partial section between 50 and 75 %, the investigators think that the technique of tangential resection compared with the direct suture would not increase the risks of secondary breaks, would authorize even an immediate mobilization and would decrease the secondary complications.

The main objective is to highlight that the tangential resection is not lower than the classic technique on the clinical plan The secondary objectives are to highlight the non-inferiority of the tangential technique in clinical terms (pains, dexterity, complications), radiologics (MRI, ultrasound) and functional (function, go back to leisures and professional activities)

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 (Participant)

入排标准

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

入选标准

  • wound dating less than 48 hours
  • partial section from 50 % to 75 % of the flexor tendons (deep and/or superficial flexors, long flexor of the thumb) in zones 1, 2, 3, T1 and T2
  • tendinous injuries on a single finger

排除标准

  • 未提供

研究组 & 干预措施

Tangential resection

Experimental

the tendon's injury is treated with a tangential resection

干预措施: tangential resection (Procedure)

Suture

Active Comparator

The tendon's injury is sutured

干预措施: suture (Procedure)

结局指标

主要结局

Total active motion Grasp

时间窗: third month,

Total active motion is the addition of angles in flexion of IPP, IPD and MCP joints of a finger in active mobility

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (2)

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