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临床试验/NCT05270551
NCT05270551尚未招募不适用

The Effect of Accelerated Rehabilitation After Anterior Cruciate Ligament Reconstruction With and Without Suture Tape Reinforcement

Assiut University0 个研究点目标入组 114 人开始时间: 2026年5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
尚未招募
入组人数
114
主要终点
Clinical outcome

研究概览

简要总结

The aim of our study is to evaluate the effect of accelerated rehabilitation post ACL reconstruction with and without augmentation on graft healing and return to normal activity clinically by scoring system and radiologically.

详细描述

ACL reconstruction is the most commonly performed knee ligament reconstruction and employs a variety of surgical techniques. However, despite high success rates, it is still challenged by residual laxity and graft rupture.

While the majority of patients who undergo ACLR will have good to excellent results, a subset of patients is at a higher risk for graft failure. For those that require revision surgery, the second operation often fails. Anterior cruciate ligament injuries account for 50% of knee ligament injuries for high school-aged adults.

The most commonly used autografts for ACLR are the hamstring tendons (HT) and the bone-patellar tendon-bone (BPTB). However, questions remain about how patients with either an HT or a BPTB autograft recover knee muscle strength postoperatively.

To help address and prevent future ACL failures, new repair and reconstruction techniques have been employed that incorporate suture augmentation. The goal of augmentation is to protect the newly repaired or reconstructed ligament during rehabilitation.

Despite advances in anterior cruciate ligament (ACL) reconstruction surgical techniques and rehabilitation, recent studies report that between 20% to 50% of those with ACL reconstruction do not return to the same sports after surgery and 10% to 70% of those who resume preinjury sports participate at a reduced level or with significant functional impairments.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
15 Years 至 50 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age from 15 to 50 years old.
  • With or without meniscal injury.
  • Isolated ACL injury without any other ligament injury.
  • Recent and chronic injury.

排除标准

  • Multiligament injury.
  • Deformed knee (Genu varus or valgus).
  • Previous ACL reconstruction or repair.
  • Older than 50 years old and younger than 15 years old.
  • Failed ACL reconstruction or repair -

研究组 & 干预措施

Group 2

Active Comparator

With augmentation

干预措施: ACL Reconstruction (Procedure)

Group 1

Active Comparator

Without augmentation

干预措施: ACL Reconstruction (Procedure)

结局指标

主要结局

Clinical outcome

时间窗: 1 year follow up

Tegner Lysholm scores, which assesses activity levels

次要结局

  • Radiological outcome(6 months follow up)

研究者

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

Mohamed Abdel-Tawab

Principal Investigator

Assiut University

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