Multiple Instrumentation for ACL Reconstruction Regarding Bacterial Contamination

July 11, 2022 updated by: Kerollos Zaghloul Thabet, Assiut University

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

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

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Assiut Univeristy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Total coverage of all eligible cases will be admitted to Arthoscopic Unit within 6 months

Description

Inclusion Criteria:

  1. Isolated ACL Injury.
  2. Non deformed knee.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
transportal group
swabs will be obtained from subcutaneous tissue at antromedial portal track in transportal technique (femoral tunnel drilling) , 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.
transtibial group
swabs will be obtained from subcutaneous tissue at antromedial portal track in transtibial technique (femoral tunnel drilling), 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Hesham HK El-kadi, professor, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2020

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

March 30, 2022

Study Registration Dates

First Submitted

September 14, 2019

First Submitted That Met QC Criteria

September 20, 2019

First Posted (Actual)

September 24, 2019

Study Record Updates

Last Update Posted (Actual)

July 13, 2022

Last Update Submitted That Met QC Criteria

July 11, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • contamination of ACL surgery

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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