NCT06166381 Parenteral Versus Combined Parenteral With Vancomycin-soaked Graft in ACL Reconstruction
| NCT ID | NCT06166381 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Duhok |
| Condition | Infection, Bacterial |
| Study Type | INTERVENTIONAL |
| Enrollment | 288 participants |
| Start Date | 2024-01-25 |
| Primary Completion | 2024-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 288 participants in total. It began in 2024-01-25 with a primary completion date of 2024-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06166381 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 45 Years, studying Infection, Bacterial. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06166381 currently recruiting?
Yes, NCT06166381 is actively recruiting participants. Contact the research team at jager.doski@uod.ac for enrollment information.
Where is the NCT06166381 trial being conducted?
This trial is being conducted at Duhok, Iraq.
Who is sponsoring the NCT06166381 clinical trial?
NCT06166381 is sponsored by University of Duhok. The trial plans to enroll 288 participants.