Actively Recruiting
Parenteral Versus Combined Parenteral With Vancomycin-soaked Graft in ACL Reconstruction
Led by University of Duhok · Updated on 2024-12-30
288
Participants Needed
1
Research Sites
53 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
An anterior cruciate ligament (ACL) tear is one of the knee joint's most common soft tissue injuries \[1\]. It is frequently injured in non-contact and some contact competition sports and even during ordinary life activities. With an annual incidence of 68.6 per 100,000 person-years, ACL tears remain a common orthopedic injury \[2\]. Females are two to eight times more likely to develop ACL tears in sports compared to men who play the same particular sports \[3\]. Most highly demanding persons and those who develop frequent instability of their knee require reconstructive surgery on the ACL to prevent early degenerative changes in their knees. This is done by completely removing the torn or ruptured ACL and replacement with a piece of tendon or ligament (graft) \[4\]. Post-operative infection may occur in 0.14-2.6% of ACL reconstruction despite intravenous antibiotics prophylaxis \[5,6\]. The deep infection results in poor outcomes with pain, stiffness, arthrofibrosis, and articular cartilage degeneration \[7,8\]. Few studies reported improved outcomes of infection control when the autograft presoaked in vancomycin solution during the preparation process outside the body before being transferred to the knee of the patient \[9-13\]. Systematic reviews and meta-analysis showed that all the articles discussing the outcome of vancomycin presoaked autograft in ACL reconstruction surgery were case series, observational retrospective, prospective comparative, or case-control studies \[14,15\]. Randomized control trial (RCT) provides the strongest evidence among the primary research studies to confirm the effectiveness of a new method of treatment \[16,17\]. To date, there is no available RCT study in this field.
CONDITIONS
Official Title
Parenteral Versus Combined Parenteral With Vancomycin-soaked Graft in ACL Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ACL injury that interferes with life activities and/or sports
You will not qualify if you...
- Previous ACL reconstruction surgery (revision surgery)
- Having inflammatory rheumatological disorders
- Refusal to participate in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
College of Medicine/University of Duhok
Duhok, Iraq, 42001
Actively Recruiting
Research Team
J
Jagar O Doski
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here