Randomized prospective clinical trial comparing reamer irrigator aspirator (RIA) to standard reaming (SR) in both minimally injured and multiply injured patients with closed femoral shaft fractures treated with reamed intramedullary nailing (IMN)

Abstract

Purpose To investigate whether inflammatory markers are improved among patients with traumatic femur fractures who undergo RIA reamed intramedullary nailing (IMN) prior to fixation when compared to patients treated with standard reamed (SR) IMN. Methods A prospective, randomized, single-blind trial was conducted on patients who had a closed femoral shaft fracture amenable to reamed IMN. Patients were randomized to undergo IMN with standard reaming or IMN with the RIA in a 1:1 ratio. Patients were stratified by Injury Severity Score (ISS) and by presence or absence of chest injury with AIS > 3. Patients had blood samples and bronchioalveolar lavage samples taken at specified time points pre- and postoperatively. Specimens from SR and RIA cohorts were compared for the presence of IL-2, IL-6, IL-8, TNF, and IL-10 in plasma and IL-1b and IL-8 in bronchioalveolar lavage (BAL) samples to determine the relationship between inflammatory markers and intramedullary reaming. Results Nineteen consecutive patients participated in the study with 9 assigned in the RIA group and 10 in SR group. Significant differences existed for ISS between SR and RIA groups (p=0.04). Bronchial lavage data showed no statistical significant differences when RIA and standard reamers were compared and when ISS >16 and <16 were compared, however there were differences for the bronchial IL-8 change when those with chest injury were compared to those without chest injury. Plasma samples showed a trend towards increased IL-6 and IL-10 levels after reaming consistent with the second hit impact. A trend towards higher levels for IL-6 in the SR group was noted at 24 hours post-operatively whereas the IL-10 levels at the post-reaming time point were higher in the RIA group. Conclusions This prospective study of reamer type indicates that RIA may be protective of systemic inflammation. This is supported by data showing decreased levels of IL-8 in the bronchial washings and increased level of IL-10 in the serum. Reaming and intramedullary fixation may cause an increase in IL-6 levels regardless of reamer type. Further investigations with a larger cohort of patients are desirable.