BackgroundStudies addressing the management of intramedullary infection are mainly retrospective and with a limited number of cases. Reaming can be performed using either conventional reaming or using the reamer/irrigator/aspirator (RIA) system. Until now there have been no comparative prospective studies between these two methods. We aimed to compare the efficacy of RIA with conventional reaming followed by insertion of antibiotic-loaded cement, for the treatment of intramedullary nail infection of long bones. We assessed the rate of remission between groups after two-year follow-up and identified microorganisms using tissue cultures and sonication of explanted intramedullary nail (IMN).MethodsA noninferiority, randomized clinical trial was carried out between August 2013 and August 2015 involving 44 patients of whom a locked IMN implant of the femur and/or tibia was retrieved and who all met the clinical and radiological criteria for IMN-associated osteomyelitis. Patients were randomized into two groups: RIA alone versus conventional reaming followed by antibiotic-loaded cement insertion. Both groups also underwent six-weeks of antibiotic treatment according to the results of the antibiogram. Patients were evaluated after 1, 3, 6, 12 and 24 months for radiological and clinical follow-up.ResultsAfter 24 months, the rate of infection remission was similar between the two groups, 87% in the RIA group and 95.5% in the conventional reaming group (p = 0.60). Among four patients who had recurrence of infection, the time to reappearance of symptoms varied from 20 days to twenty-two months. Staphylococcus aureus and coagulase-negative Staphylococci were isolated in 23 (40.4%) and 13 (22.9%) patients, respectively. Interestingly, we identified 20% (9/45) of polymicrobial infection.ConclusionThis study concludes that the RIA system alone, is noninferior to conventional reaming followed by antibiotic cement spacer in the treatment of IMN infection. However, RIA shows greater efficacy in the collection of infected medullary bone tissue, mainly in cases of infected retrograde nail of the femur.Trial registrationISRCTN82233198. Retroactively registered on July 29, 2019.