Multiple Instrumentation for ACL Reconstruction Regarding Bacterial Contamination

Anterior Cruciate Ligament Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04100837
• Other study ID #: contamination of ACL surgery
• Status: Completed
• Start date: January 15, 2020
• Est. completion date: March 30, 2022

Study information

• Verified date: July 2022
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 30, 2022
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries

Locations

Country	Name	City	State
Egypt	Assiut Univeristy	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Barnstable CJ, Jones EA, Bodmer WF, Bodmer JG, Arce-Gomez B, Snary D, Crumpton MJ. Genetics and serology of HL-A-linked human Ia antigens. Cold Spring Harb Symp Quant Biol. 1977;41 Pt 2:443-55. — View Citation

Outcome

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