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Completed

NCT Number: NCT04100837

Multiple Instrumentation for ACL Reconstruction Regarding Bacterial Contamination

To determine the Effect of multiple instrumentation regarding bacterial contamination in transportal and transtibial techniques in ACL reconstruction .A Randomized controlled study

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Key information

Conditions

Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Assiut Univeristy

Asyut, Egypt

About this study

Infection is a catastrophic and one of the most dreaded complications in orthopaedic surgery. Several measures have been undertaken to reduce the risk of infection, one of which is the use of systemic prophylactic antibiotics.

The purpose of this study is to determine the effect of multiple instrumentation regarding bacterial contamination in transportal and transtibial techniques in ACL reconstruction . About Eighty consecutive patients having surgical indication for ACL-R will be included, the cases will be divided into two groups, 35 cases will undergo for the transtibial technique and the other 45 cases will undergo for the transportal technique. After preparation, swabs will be obtained from subcutaneous tissue at antromedial portal track in transportal technique (femoral tunnel drilling) and in transtibial technique before and after the instrumentation and femoral screw insertion, a control sample will be taken at antrolateral track in both techniques, then samples will be sended to the lab to be studied.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Isolated ACL Injury.
  • Non deformed knee.

Exclusion criteria

  • Associated knee injury (eg. PCL).
  • Deformed knee ( eg. genu varus , genu valgus more than 4 degree )
  • patient with medical history of being immune compromized patient eg,DM

Treatment and study plan

Primary outcomes

  1. Assessment the concentration of contamination in ACL operation.

    Time frame: Through study completion, an average of 1 year.

    Effect of instrumentation on contamination of the operation,swabs will be obtained intraoperative for cultures.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Effect of Multiple Instrumentation in Transportal and Transtibial Techniques for ACL Reconstruction Regarding Bacterial Contamination: A Randomized Control Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Sep 24, 2019
Registry last updated
Jul 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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