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临床试验/NCT07236593
NCT07236593已完成不适用

Remnant Preservation in Anterior Cruciate Ligament Reconstruction: Does Stump Suturing Reduce the Risk of Tibial Tunnel Widening? A CT-Based Study

Cairo University1 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2021年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
190
试验地点
1
主要终点
Rate of Tibial Tunnel Enlargement

研究概览

简要总结

Anterior Cruciate Ligament (ACL) reconstruction is one of the most commonly performed orthopedic procedures. Tibial tunnel widening is a recognized postoperative complication that may affect graft stability and long-term outcomes. Recent studies have suggested that preserving the ACL remnant may improve biological healing and reduce tunnel widening, but the evidence remains inconclusive.

This prospective randomized study aims to evaluate whether remnant (stump) preservation and suturing during ACL reconstruction can reduce the risk of tibial tunnel widening compared with the conventional stump-resection technique.

A total of 190 patients with recent ACL tears (<6 months) were randomly assigned into two equal groups: Group A underwent arthroscopic ACL reconstruction with remnant suturing, while Group B underwent standard reconstruction with stump resection. All patients were followed for 12 months postoperatively with serial CT evaluations to assess tunnel diameters and positioning.

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
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 45 years
  • Acute ACL injury (<6 months)
  • Medically fit for surgery

排除标准

  • Age <18 or >45 years
  • Old or chronic ACL injuries (>6 months)
  • Multi-ligamentous knee injuries
  • Failed previous ACL reconstruction
  • Associated mal-alignment deformities
  • Absence of identifiable ACL stump

结局指标

主要结局

Rate of Tibial Tunnel Enlargement

时间窗: 12 months postoperatively

次要结局

  • Percentage of Tibial Tunnel Enlargement(12 months)
  • Tibial Tunnel Positioning (X & Y coordinates)(2 Weeks)
  • Femoral Tunnel Positioning (X & Y coordinates)(2 Weeks)
  • Femoral Tunnel Diameter Change(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mahmoud Ahmed El-Desouky

Associate Professor of Orthopedic surgery

Cairo University

研究点 (1)

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