Anterior cruciate ligament injury: diagnosis, management, and prevention.
Francesca Cimino, Bradford Scott Volk, Don Setter
https://pubmed.ncbi.nlm.nih.gov/20949884Actively Recruiting
Phase Not Applicable
Age: 20Years - 45Years
All Genders
ID06166381
Parenteral Versus Combined Parenteral With Vancomycin-soaked Graft in Decreasing the Risk of Infection in ACL Reconstruction Surgery: A Randomized Controlled Trial
Led by University of Duhok · Updated on 2024-12-30
288
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Anterior cruciate ligament (ACL) tears are common knee injuries, often affecting people involved in sports or daily activities. Females are more likely to experience these injuries compared to males. Many patients with frequent knee instability undergo ACL reconstruction surgery, which involves replacing the torn ligament with a graft. Postoperative infection is a serious complication that can lead to pain, stiffness, and joint damage. Previous studies have suggested that soaking the graft in vancomycin may reduce infection risk, but no randomized controlled trials have been conducted to confirm this. This study is a randomized controlled trial comparing two methods to prevent infection in ACL reconstruction surgery. One group will receive only parenteral antibiotics (ceftriaxone) given at anesthesia induction and for two days afterward. The other group will receive the same antibiotic treatment plus soaking the ACL graft in a vancomycin solution for 20 minutes before implantation. Participants will be randomly assigned to either group in equal numbers. Participants aged 20 to 45 years with ACL injuries needing reconstruction will be followed for six months after surgery. Researchers will monitor for signs of infection during this period. The study will collect data on infection rates and other health outcomes to determine if vancomycin soaking reduces infection risk. The total participation time includes surgery and follow-up visits up to six months postoperatively.
CONDITIONS
Brief Title
Parenteral Versus Combined Parenteral With Vancomycin-soaked Graft in ACL Reconstruction
Who Can Participate
Age: 20Years - 45Years
All Genders
Eligibility Criteria
You may qualify if you...
- ACL injury that interferes with life activities and/or sports
- Age between 20 and 45 years
- Any sex
- Willingness to participate in the study
You will not qualify if you...
- Patients undergoing revision surgery of ACL reconstruction
- Presence of inflammatory rheumatological disorders
- Refusal to participate in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - 1 day
Participants undergo ACL reconstruction surgery and receive either parenteral antibiotics alone or parenteral antibiotics combined with vancomycin presoaked graft to prevent infection.
1 surgery visit
Post-operative Follow-up
Duration - Up to 6 months postoperatively
Participants are monitored for signs of infection and recovery following surgery.
Approximately 6 visits over 6 months
Trial Site Locations
Total: 1 location
1
College of Medicine/University of Duhok
Duhok, Iraq, 42001
Actively Recruiting
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Research Team
J
Jagar O Doski
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Incidence of Anterior Cruciate Ligament Tears and Reconstruction: A 21-Year Population-Based Study.
Thomas L Sanders, Hilal Maradit Kremers, Andrew J Bryan...
https://pubmed.ncbi.nlm.nih.gov/26920430Quantitation of estrogen receptors and relaxin binding in human anterior cruciate ligament fibroblasts.
Deborah A Faryniarz, Madhu Bhargava, Claudette Lajam...
https://pubmed.ncbi.nlm.nih.gov/16948498Meta-analysis of the Risk of Infections After Anterior Cruciate Ligament Reconstruction by Graft Type.
Anchal Bansal, Joseph D Lamplot, James VandenBerg...
https://pubmed.ncbi.nlm.nih.gov/28737955Incidence of postoperative anterior cruciate ligament reconstruction infections: graft choice makes a difference.
Gregory B Maletis, Maria C S Inacio, Sarah Reynolds...
https://pubmed.ncbi.nlm.nih.gov/23749343Long-term outcomes of postoperative septic arthritis after anterior cruciate ligament reconstruction.
David L Schub, Leah M Schmitz, Flavia A Sakamoto...
https://pubmed.ncbi.nlm.nih.gov/23087081Infections in anterior cruciate ligament reconstruction.
Charlton Stucken, David N Garras, Julie L Shaner...
https://pubmed.ncbi.nlm.nih.gov/24427432A surgical technique using presoaked vancomycin hamstring grafts to decrease the risk of infection after anterior cruciate ligament reconstruction.
Christopher J Vertullo, Mark Quick, Andrew Jones...
https://pubmed.ncbi.nlm.nih.gov/22112612Autograft soaking in vancomycin reduces the risk of infection after anterior cruciate ligament reconstruction.
Daniel Pérez-Prieto, Raúl Torres-Claramunt, Pablo E Gelber...
https://pubmed.ncbi.nlm.nih.gov/25416672No infections in 1300 anterior cruciate ligament reconstructions with vancomycin pre-soaking of hamstring grafts.
Michael Phegan, Jane E Grayson, Christopher J Vertullo
https://pubmed.ncbi.nlm.nih.gov/25771788