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

Infection, Bacterial Clinical Trial

Official title:

Parenteral Versus Combined Parenteral With Vancomycin-soaked Graft in Decreasing the Risk of Infection in ACL Reconstruction Surgery: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06166381
• Other study ID #: 123456789
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 25, 2024
• Est. completion date: February 2025

Study information

• Verified date: January 2024
• Source: University of Duhok
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 288
• Est. completion date: February 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bacterial Infections
• Infection, Bacterial
• Infections

Intervention

Drug:
• Parenteral Antibacterial Agents
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
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Duhok

References & Publications (16)

Bansal A, Lamplot JD, VandenBerg J, Brophy RH. Meta-analysis of the Risk of Infections After Anterior Cruciate Ligament Reconstruction by Graft Type. Am J Sports Med. 2018 May;46(6):1500-1508. doi: 10.1177/0363546517714450. Epub 2017 Jul 24. — View Citation

Bohu Y, Klouche S, Sezer HB, Herman S, Grimaud O, Gerometta A, Meyer A, Lefevre N. Vancomycin-soaked autografts during ACL reconstruction reduce the risk of post-operative infection without affecting return to sport or knee function. Knee Surg Sports Trau — View Citation

Carrozzo A, Saithna A, Ferreira A, Guy S, Chadli L, Monaco E, Perez-Prieto D, Bohu Y, Vieira TD, Sonnery-Cottet B. Presoaking ACL Grafts in Vancomycin Decreases the Frequency of Postoperative Septic Arthritis: A Cohort Study of 29,659 Patients, Systematic — View 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. — View 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. — View Citation

Hu M, Zhang Y, Shang G, Guo J, Xu H, Ma X, Yang X, Xiang S. Vancomycin presoak reduces infection in anterior cruciate ligament reconstruction: a systematic review and meta-analysis. BMC Musculoskelet Disord. 2023 Apr 5;24(1):267. doi: 10.1186/s12891-023-0 — View Citation

Kapoor MC. Types of studies and research design. Indian J Anaesth. 2016 Sep;60(9):626-630. doi: 10.4103/0019-5049.190616. — View Citation

Maletis GB, Inacio MC, Reynolds S, Desmond JL, Maletis MM, Funahashi TT. Incidence of postoperative anterior cruciate ligament reconstruction infections: graft choice makes a difference. Am J Sports Med. 2013 Aug;41(8):1780-5. doi: 10.1177/036354651349066 — View Citation

Murad MH, Asi N, Alsawas M, Alahdab F. New evidence pyramid. Evid Based Med. 2016 Aug;21(4):125-7. doi: 10.1136/ebmed-2016-110401. Epub 2016 Jun 23. — View 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 — View Citation

Phegan M, Grayson JE, Vertullo CJ. No infections in 1300 anterior cruciate ligament reconstructions with vancomycin pre-soaking of hamstring grafts. Knee Surg Sports Traumatol Arthrosc. 2016 Sep;24(9):2729-2735. doi: 10.1007/s00167-015-3558-z. Epub 2015 M — View Citation

Rodriguez-Merchan EC, Ribbans WJ. The role of vancomycin-soaking of the graft in anterior cruciate ligament reconstruction. J ISAKOS. 2022 Apr;7(2):94-98. doi: 10.1016/j.jisako.2021.12.006. Epub 2022 Jan 7. — View 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: 10.1177/03635465166 — View Citation

Schub DL, Schmitz LM, Sakamoto FA, Winalski CS, Parker RD. Long-term outcomes of postoperative septic arthritis after anterior cruciate ligament reconstruction. Am J Sports Med. 2012 Dec;40(12):2764-70. doi: 10.1177/0363546512461903. Epub 2012 Oct 19. — View Citation

Stucken C, Garras DN, Shaner JL, Cohen SB. Infections in anterior cruciate ligament reconstruction. Sports Health. 2013 Nov;5(6):553-7. doi: 10.1177/1941738113489099. — View Citation

Vertullo CJ, Quick M, Jones A, Grayson JE. A surgical technique using presoaked vancomycin hamstring grafts to decrease the risk of infection after anterior cruciate ligament reconstruction. Arthroscopy. 2012 Mar;28(3):337-42. doi: 10.1016/j.arthro.2011.0 — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	infection	deep infection occurs around the graft of the ACL	1st day postoperative upto 6 months