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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-45
SponsorUniversity of Duhok

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ACL injury that interferes with life activities and/or sports

Disqualifiers

Patients for revision surgery of ACL reconstruction

patients with inflammatory rheumatological disorders

Refusal to participate in the study.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Parenteral Antibacterial Agents

    Drug

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

  • Parenteral Antibacterial Agents plus Vancomycin pre-soaked graft

    Drug

    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.

Treatment groups

288 Participants
are divided into 2 treatment groups
Group A: controlActive comparator 1 intervention
Group B: clinical trialExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

infection

deep infection occurs around the graft of the ACL

Time frame
1st day postoperative upto 6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.