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Parenteral Versus Combined Parenteral With Vancomycin-soaked Graft in ACL Reconstruction

NCT06166381 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2024-12-30

No results posted yet for this study

Summary

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

  • Infection, Bacterial

Interventions

DRUG

Parenteral Antibacterial Agents

Parenteral antibiotic (ceftriaxone) 1 g to be given in 3 doses, at induction of anesthesia, 12 hours postoperative, and 24 hours postoperative.

DRUG

Parenteral Antibacterial Agents plus Vancomycin pre-soaked graft

in addition to the parenteral ceftriaxone intravenous injections, the ACL graft will be soaked in the vancomycin solution for 20 minutes when prepared outside the body of patient.

Sponsors & Collaborators

  • University of Duhok

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-25
Primary Completion
2024-12-31
Completion
2025-02-28

Countries

  • Iraq

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06166381 on ClinicalTrials.gov