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临床试验/NCT01106963
NCT01106963已完成不适用

Nail Position Has an Influence on Anterior Knee Pain After Tibial Intramedullary Nailing

University of Zagreb1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2006年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Anterior knee pain

研究概览

简要总结

Anterior knee pain (AKP) is a common complication following intramedullary (IM) nailing of a tibial shaft fracture. The purpose of this prospective study was to determine if there is an association between AKP and nail position. The investigators have analyzed postoperative outcome results and the possible relationship between AKP according to the visual-analog scale (VAS) scale, and nail position marked as a distance from the tip of the nail to the tibial plateau (NP) and tuberositas tibiae (NT), measured postoperatively on L-L knee X-rays.

详细描述

The aim of this study was to determine the possible relationship between anterior knee pain (AKP) and nail position marked as a distance from tip of nail to tibial plateau (NP) and to the tuberositas tibiae (NT).

We evaluated postoperative outcome results of 50 patients in the last 3 years with healed fractures initially treated with intramedullary (IM) reamed nails with 2 or 3 interlocking screws on both parts of the nail and with the use of medial peritendinous incision for nail entry portal. Patients marked a point on the visual analog scale (VAS) that corresponded to the level of postoperative AKP felt. Two groups of patients were formed on the basis of AKP (pain level was neglected): groups A and B, with and without pain, respectively.

We found that the difference between the two groups concerning NP measurements was statistically significant, but not concerning NT measurements (P < 0.05). Patients were classified by pain with high accuracy (98%) according to a classification tree.

We conclude that the symptoms of AKP did not appear if the tip of the nail position was more than 6.0 mm from the NP and more than 2.6 mm from the NT. However, for better evaluation of these results it will be necessary to examine more postoperative patients with AKP.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • tibial shaft fractures
  • fracture treatment with intramedullary nailing with 2 or 3 interlocking screws on both ends of the nail

排除标准

  • amputated legs

结局指标

主要结局

Anterior knee pain

时间窗: 1 year

Anterior knee pain was assessed postoperatively with the visual analog scale (VAS). Patients generally had pain when kneeling, at the insertion point of surgical screws, or at the back of knee upon flexing.

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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