Clinical trial NCT06166381: Parenteral Versus Combined Parenteral With Vancomycin-soaked Graft in ACL Reconstruction
Official title: Parenteral Versus Combined Parenteral With Vancomycin-soaked Graft in Decreasing the Risk of Infection in ACL Reconstruction Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infection, Bacterial
Keywords: Anterior cruciate ligament
reconstruction
infection
vancomycin presoaked graft
Lead sponsor: University of Duhok
Sponsor class: OTHER
First posted: 2023-12-12
Enrollment: 288
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: Aim This study aims to do RTC research on the role of vancomycin-presoaked autograft in ACL reconstruction to decrease the risk of infection.

Objectives To treat patients undergoing ACL reconstruction surgery by two methods to prevent infection (parenteral antibiotic and combined parenteral antibiotic with vancomycin presoaked autograft). To compare between odds ratio of infection occurrence. To check the superiority of the added vancomycin presoaked method in decreasing the risk of infection.

Methods Study type It will be a randomized controlled clinical trial of superiority type. It will be based on a parallel-group type with an allocation ratio of 1:1.

Study setting The research will be conducted in the orthopedic unit, at Azadi Teaching Hospital, Duhok, Iraq.

Inclusion criteria Patients between the ages of 20 to 45 years, of any sex, with ACL dysfunction and needing ACL reconstruction surgery, will be involved in this research.

Exclusion criteria Patients for revision surgery of ACL reconstruction, inflammatory rheumatological disorders, and refusal to participate in the study.

Interventions The patients will be divided into 2 groups: group one (control) will be those who will receive only parenteral antibiotics at induction of anesthesia and for 5 days after the operation. The second group (trial) will receive parenteral antibiotics combined with soaking the autograft of ACL autograft into the vancomycin solution duration preparation of the graft recipient site.

Outcomes The primary outcome will be the odds of cases developing signs of infection up to 6 months postoperatively. No secondary outcome will be recorded for this study.

Sample size The assumed sample size was calculated by using the G\*Power 3.1.9.7 computer software program. A minimum of 288 participants (144 for each group) are required to have an 80% chance of detecting the difference between the groups with a two-sided 95% confidence level (0.05 level of significance) to achieve a difference in the odds ratio of 1.8.

Randomization

The allocation of the participants into the modalities of the treatment will be done by a simple randomization method with an allocation ratio of 1:1. It will be generated by using the website program www.randomization.com.

Statistical analysis The data analysis will be performed by SPSS 23.0. The statistical analysis will include the standard descriptive statistics used to describe the basic descriptive data of the patients. The means and standard deviations (SD) or medians and interquartile ranges were used for the continuous variables, while frequencies and percentages were used for the categorical variables. The comparison between the outcomes of the treatment modalities in both groups will be done by finding the difference between the summary statistics in the Chi-squared test. The difference will be considered statistically significant when the p-value is less than 0.05.

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.

Primary outcomes:
measure: infection
timeFrame: 1st day postoperative upto 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Duhok
country: Iraq
facility: College of Medicine/University of Duhok
Study officials:
References:
citation: Cimino F, Volk BS, Setter D. Anterior cruciate ligament injury: diagnosis, management, and prevention. Am Fam Physician. 2010 Oct 15;82(8):917-22.
citation: Sanders TL, Maradit Kremers H, Bryan AJ, Larson DR, Dahm DL, Levy BA, Stuart MJ, Krych AJ. Incidence of Anterior Cruciate Ligament Tears and Reconstruction: A 21-Year Population-Based Study. Am J Sports Med. 2016 Jun;44(6):1502-7. doi: 10.1177/0363546516629944. Epub 2016 Feb 26.
citation: Faryniarz DA, Bhargava M, Lajam C, Attia ET, Hannafin JA. Quantitation of estrogen receptors and relaxin binding in human anterior cruciate ligament fibroblasts. In Vitro Cell Dev Biol Anim. 2006 Jul-Aug;42(7):176-81. doi: 10.1290/0512089.1.
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citation: Perez-Prieto D, Torres-Claramunt R, Gelber PE, Shehata TMA, Pelfort X, Monllau JC. Autograft soaking in vancomycin reduces the risk of infection after anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 2016 Sep;24(9):2724-2728. doi: 10.1007/s00167-014-3438-y. Epub 2014 Nov 22.
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