Actively Recruiting

Phase Not Applicable
Age: 20Years - 45Years
All Genders
NCT06166381

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

Age: 20Years - 45Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • ACL injury that interferes with life activities and/or sports
Not Eligible

You will not qualify if you...

  • Previous ACL reconstruction surgery (revision surgery)
  • Having inflammatory rheumatological disorders
  • Refusal to participate in the study

AI-Screening

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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

CONTACT

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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