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Many investigations have evaluated local and systemic consequences of intramedullary (IM) reaming and suggest that reaming may cause, or exacerbate, injury to the soft tissues adjacent to fractures. To date, no study has examined the effect on local muscular physiology as measured by intramuscular pH (IpH). Here, we observe in vivo IpH during IM reaming for tibia fractures. Methods: Adults with acute tibia shaft fractures (level 1, academic, 2019-2021) were offered enrollment in an observational cohort. During IM nailing, a sterile, validated IpH probe was placed into the anterior tibialis (<5 cm from fracture, continuous sampling, independent research team). IpH before, during, and after reaming was averaged and compared through repeated measures ANOVA. As the appropriate period to analyze IpH during reaming is unknown, the analysis was repeated over periods of 0.5, 1, 2, 5, 10, and 15 minutes prereaming and postreaming time intervals. Results: Sixteen subjects with tibia shaft fractures were observed during nailing. Average time from injury to surgery was 35.0 hours (SD, 31.8). Starting and ending perioperative IpH was acidic, averaging 6.64 (SD, 0.21) and 6.74 (SD, 0.17), respectively. Average reaming time lasted 15 minutes. Average IpH during reaming was 6.73 (SD, 0.15). There was no difference in IpH between prereaming, intrareaming, and postreaming periods. IpH did not differ regardless of analysis over short or long time domains compared with the duration of reaming. Conclusions: Reaming does not affect IpH. Both granular and broad time domains were tested, revealing no observable local impact.
RESUMO
INTRODUCTION: Orthopaedic trauma and fracture care commonly cause perioperative anaemia and associated functional iron deficiency due to a systemic inflammatory state. Modern, strict transfusion thresholds leave many patients anaemic; managing this perioperative anaemia is an opportunity to impact outcomes in orthopaedic trauma surgery. The primary outcome of this pilot study is feasibility for a large randomised controlled trial (RCT) to evaluate intravenous iron therapy (IVIT) to improve patient well-being following orthopaedic injury. Measurements will include rate of participant enrolment, screening failure, follow-up, missing data, adverse events and protocol deviation. METHODS AND ANALYSIS: This single-centre, pilot, double-blind RCT investigates the use of IVIT for acute blood loss anaemia in traumatically injured orthopaedic patients. Patients are randomised to receive either a single dose infusion of low-molecular weight iron dextran (1000 mg) or placebo (normal saline) postoperatively during their hospital stay for trauma management. Eligible subjects include adult patients admitted for lower extremity or pelvis operative fracture care with a haemoglobin of 7-11 g/dL within 7 days postoperatively during inpatient care. Exclusion criteria include history of intolerance to intravenous iron supplementation, active haemorrhage requiring ongoing blood product resuscitation, multiple planned procedures, pre-existing haematologic disorders or chronic inflammatory states, iron overload on screening or vulnerable populations. We follow patients for 3 months to measure the effect of iron supplementation on clinical outcomes (resolution of anaemia and functional iron deficiency), patient-reported outcomes (fatigue, physical function, depression and quality of life) and translational measures of immune cell function. ETHICS AND DISSEMINATION: This study has ethics approval (Oregon Health & Science University Institutional Review Board, STUDY00022441). We will disseminate the findings through peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: NCT05292001; ClinicalTrials.gov.
