Pathological fracture risk assessment in patients with femoral metastases using CT-based finite element methods. A retrospective clinical study.

Physician recommendation for prophylactic surgical fixation of a femur with metastatic bone disease (MBD) is usually based on Mirels' criteria and clinical experience, both of which suffer from poor specificity. This may result in a significant number of these health compromised patients undergoing unnecessary surgery. CT-based finite element analyses (CTFEA) have been shown to accurately predict strength in femurs with metastatic tumors in an ex-vivo study. In order to assess the utility of CTFEA as a clinical tool to determine the need for fixation of patients with MBD of the femur, an ad hoc CTFEA was performed on a retrospective cohort of fifty patients. Patients with CT scans appropriate for CTFEA analysis were analyzed. Group 1 was composed of 5 MBD patients who presented with a pathologic femoral fracture and had a scan of their femurs just prior to fracture. Group 2 was composed of 45 MBD patients who were scheduled for a prophylactic surgery because of an impending femoral fracture. CTFEA models were constructed for both femurs for all patients, loaded with a hip contact force representing stance position loading accounting for the patient's weight and femur anatomy. CTFEA analysis of Group 1 patients revealed that they all had higher tumor associated strains compared to typical non-diseased femur bone strains at the same region (>45%). Based on analysis of the 5 patients in Group 1, the ratio between the absolute maximum principal strain in the vicinity of the tumor and the typical median strain in the region of the tumor of healthy bones (typical strain fold ratio) was found to be the 1.48. This was considered to be the predictive threshold for a pathological femoral fracture. Based on this typical strain fold ratio, twenty patients (44.4%) in Group 2 were at low risk of fracture and twenty-five patients (55.5%) high risk of fracture. Eleven patients in Group 2 choose not to have surgery and none fractured in the 5month follow-up period. CTFEA predicted that seven of these patients were below the pathological fracture threshold and four above, for a specificity of 63% Based on CTFEA, 39% of the patients with femoral MBD who were referred and underwent prophylactic stabilization may not have needed surgery. These results indicate that a prospective randomized clinical trial evaluating CTFEA as a criterion for determining the need for surgical stabilization in patients with MBD of the femur may be warranted.