Multiple Instrumentation for ACL Reconstruction Regarding Bacterial Contamination

NCT04100837 | Completed

• 1 other identifier: contamination of ACL surgery
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anterior Cruciate Ligament Injuries

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Isolated ACL Injury.
• Non deformed knee.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut Univeristy

Asyut, Egypt

Location

Related 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. doi: 10.1101/sqb.1977.041.01.052. No abstract available.

  PMID: 70300 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

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.

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Hesham HK El-kadi, professor

  Assiut University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedics & traumatology doctor

Study Record Dates

• First Submitted: September 14, 2019
• First Posted: September 24, 2019
• Study Start: January 15, 2020
• Primary Completion: September 30, 2021
• Study Completion: March 30, 2022
• Last Updated: July 13, 2022

Record last verified: 2022-07

Locations

EG (1)