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What Is the Adverse Event Profile After Prophylactic Treatment of Femoral Shaft or Distal Femur Metastases?

McLynn, Ryan P., MD; Ondeck, Nathaniel T., MD; Grauer, Jonathan N., MD; Lindskog, Dieter M., MD

Clinical Orthopaedics and Related Research®: December 2018 - Volume 476 - Issue 12 - p 2381–2388
doi: 10.1097/CORR.0000000000000489
CLINICAL RESEARCH
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Background Prophylactic surgical treatment of the femur is commonly offered to patients with metastatic disease who have a high risk of impending pathologic fracture. Prophylactic fixation is associated with improved functional outcomes in appropriate patients selected based on established criteria, but the perioperative complication profile has received little attention. Given the substantial comorbidity in this population, it is important to characterize surgical risks for surgeons and patients to improve treatment decisions.

Questions/purposes (1) What is the incidence of postoperative adverse events after prophylactic surgical stabilization of metastatic lesions of the femoral shaft or distal femur? (2) How does this complication profile compare with stabilization of pathologic fractures adjusted for differences in patient demographics and comorbidity?

Methods We performed a retrospective study using the National Surgical Quality Improvement Program (NSQIP) database. We identified patients undergoing prophylactic treatment of the femoral shaft or distal femur by Current Procedural Terminology (CPT) codes. Patients undergoing treatment of a pathologic fracture were identified by CPT code for femur fracture fixation as well as an International Classification of Diseases code indicating neoplasm or pathologic fracture. We tracked adverse events, operative time, blood transfusion, hospital length of stay, and discharge to a facility within 30 days postoperatively. There were 332 patients included in the prophylactic treatment group and 288 patients in the pathologic fracture group. Patients in the prophylactic treatment group presented with greater body mass index (BMI), whereas the pathologic fracture group presented with a greater incidence of disseminated cancer. The odds of experiencing adverse events were initially compared between the two groups using bivariate logistic regression and then using multivariate regression controlling for age, sex, BMI, and American Society of Anesthesiologists (ASA) class and disseminated cancer causing marked physiological compromise per NSQIP guidelines.

Results With multivariate analysis controlling for age, sex, BMI, and ASA class, patients with pathologic fracture were more likely to experience any adverse event (odds ratio [OR], 1.53; 95% confidence interval [CI], 1.03-2.29; p = 0.036), major adverse events (OR, 1.61; 95% CI, 1.01-2.55; p = 0.043), death (OR, 1.90; 95% CI, 1.07-3.38; p = 0.030), blood transfusion (OR, 1.57; 95% CI, 1.08-2.27; p = 0.017), and hospital stay ≥ 9 days (OR, 1.51; 95% CI, 1.05-2.19; p = 0.028) compared with patients undergoing prophylactic treatment. However, when additionally controlling for disseminated cancer, the only difference was that patients with pathologic fractures were more likely to receive a blood transfusion than were patients undergoing prophylactic fixation (OR, 1.61; 95% CI, 1.12-2.36; p = 0.011).

Conclusions After controlling for differences in patient characteristics, prophylactic treatment of femoral metastases was associated with a decreased likelihood of blood transfusion and no differences in terms of the frequency of other adverse events. In the context of prior studies supporting the mechanical and functional outcomes of prophylactic treatment, the findings of this cohort suggest that the current guidelines have achieved a reasonable balance of morbidity in patients with femoral lesions and further support the current role of prophylactic treatment of impending femur fractures in appropriately selected patients.

Level of Evidence Level III, therapeutic study.

R. P. McLynn, N. T. Ondeck, J. N. Grauer, D. M. Lindskog, Department of Orthopaedics and Rehabilitation, Yale School of Medicine, New Haven, CT, USA

R. P. McLynn, Department of Orthopaedic Surgery, University of Alabama at Birmingham School of Medicine, Birmingham, AL, USA

N. T. Ondeck, Department of Orthopedic Surgery, Hospital for Special Surgery, New York, NY, USA

J. N. Grauer, Department of Orthopaedics and Rehabilitation, Yale School of Medicine, 47 College Street, New Haven, CT 06510, USA, email: jonathan.grauer@yale.edu

The institution of one or more of the authors (RPM) has received, during the study period, funding from the James G. Hirsch, MD, Endowed Medical Student Fellowship at Yale University (New Haven, CT, USA) in an amount less than USD 10,000. One of the authors (JNG) certifies that he, or a member of his immediate family, has received or may receive payments or benefits, during the study period, an amount of less than USD 10,000 from Andante Medical Services (White Plains, NY, USA); an amount of less than USD 10,000 from Vertex (Boston, MA, USA); an amount of less than USD 10,000 from Bioventus (Durham, NC, USA); an amount of USD 10,000 to USD 100,000 from Stryker (Kalamazoo, MI, USA); and an amount of less than USD 10,000 from the Orthopaedic Trauma Association (Rosemont, IL, USA), none related to this study.

All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research® editors and board members are on file with the publication and can be viewed on request.

Clinical Orthopaedics and Related Research® neither advocates nor endorses the use of any treatment, drug, or device. Readers are encouraged to always seek additional information, including FDA approval status, of any drug or device before clinical use.

Each author certifies that his institution waived approval for the reporting of this investigation and that all investigations were conducted in conformity with ethical principles of research.

This work was performed at Yale School of Medicine, New Haven, CT, USA.

Received April 11, 2018

Accepted August 22, 2018

© 2018 Lippincott Williams & Wilkins LWW
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