Parenteral Versus Combined Parenteral With Vancomycin-soaked Graft in ACL Reconstruction
Status:
Not yet recruiting
Trial end date:
2025-02-01
Target enrollment:
Participant gender:
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.