Multiple Instrumentation for ACL Reconstruction Regarding Bacterial Contamination

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04100837

Enrollment

Registered

2019-09-24

Start date

2020-01-15

Completion date

2022-03-30

Last updated

2022-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Cruciate Ligament Injuries

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Assessment the concentration of contamination in ACL operation.	Through study completion, an average of 1 year.	Effect of instrumentation on contamination of the operation,swabs will be obtained intraoperative for cultures.

Countries

Egypt

Outcome results