Impact of intramedullary instrumentation versus damage control for femoral fractures on immunoinflammatory parameters: prospective randomized analysis by the EPOFF Study Group.

BACKGROUND: Damage control orthopedic surgery has recently been advocated for the management of femoral shaft fractures in severely injured patients because surgical procedures were found to represent a second-hit phenomenon regarding the operative burden. It has been attempted to determine the operative burden by means of proinflammatory cytokines. In this study in clinically stable patients with multiple injuries, the effects induced by different types of primary fracture stabilization on the systemic release of proinflammatory cytokines were evaluated.
METHODS: This was a prospective, randomized, multicenter intervention study. Inclusion criteria were long bone shaft fracture of the lower extremity; age 18 to 65 years; Injury Severity Score > 16 or more than three extremity injuries (Abbreviated Injury Scale [AIS] score of 2 or more) in association with another injury (AIS score of 2 or more); and thoracic AIS score < 4. After informed consent, randomization for the treatment of the femoral shaft fracture was performed at admission. Groups were as follows: group I degrees FN (primary, < 24 hours) intramedullary nailing, and group DCO (DCO, I degrees ex.fix.) damage control orthopedic surgery and external fixation. In DCO patients, measurements were also performed at the time of conversion to the intramedullary procedure (DCO II degrees FN). Parameters included clinical parameters and complications (acute respiratory distress syndrome, multiple organ failure, sepsis). From serially sampled central venous blood, the perioperative concentrations of interleukin IL-1, IL-6, and IL-8 were determined. RESULTS Thirty-five patients were included (I degrees FN, n = 17; DCO, n = 18). In I degrees FN-patients, a perioperative increase of IL-6 levels was measured (preoperatively, 55 +/- 33 pg/dL; 24 hours postoperatively, +254 +/- 55 pg/dL; p = 0.03), which was not found in subgroup DCO I degrees Ex.fix.: preoperatively, 71 +/- 42 pg/dL; 24 hours postoperatively, 68 +/- 34 pg/dL; not significant [NS] or in group DCO II degrees FN: preoperatively, 36 +/- 21 pg/dL; 24 hours postoperatively, +39 +/- 25 pg/dL; NS. Likewise, in I degrees FN patients, a perioperative increase of IL-8 levels was measured only at the 7-hour time point (preoperatively, 35 +/- 29 pg/dL; 7 hours postoperatively, 95 +/- 23 pg/dL; p < 0.05), which was not found in group DCO I degrees Ex.fix.: preoperatively, 43 +/- 38 pg/dL; 24 hours postoperatively, 69 +/- 39 pg/dL; NS or in group DCO II degrees FN: preoperatively, 25 +/- 20 pg/dL; 24 hours postoperatively, 36 +/- 29 pg/dL; NS. There were no differences in the complication rate in terms of acute respiratory distress syndrome, sepsis, or multiple organ failure.
CONCLUSION: In this prospective, randomized, multicenter study, a sustained inflammatory response was measured after primary (<24 hours) intramedullary femoral instrumentation, but not after initial external fixation or after secondary conversion to an intramedullary implant. These findings may become clinically relevant in patients at high risk of developing complications. It confirms previous studies in that damage control orthopedic surgery appears to minimize the additional surgical impact induced by acute stabilization of the femur.

RCT Entities:   Population Interventions Outcomes