Overview

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

Status:
Not yet recruiting

Trial end date:
2025-02-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

N/A

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of Duhok

Treatments:

Anti-Bacterial Agents
Ceftriaxone
Vancomycin

Criteria

Inclusion Criteria:

- ACL injury that interferes with life activities and/or sports

Exclusion Criteria:

- Patients for revision surgery of ACL reconstruction

- patients with inflammatory rheumatological disorders

- Refusal to participate in the study.