Background context:

While osteoporosis is a risk factor for adverse outcomes in spinal fusion patients, diagnosing osteoporosis reliably in this population has been challenging due to degenerative changes and spinal deformities. Addressing that challenge, biomechanical computed tomography analysis (BCT) is a CT-based diagnostic test for osteoporosis that measures both bone mineral density and bone strength (using finite element analysis) at the spine; CT scans taken for spinal evaluation or previous care can be repurposed for the analysis.

Purpose:

Assess the effectiveness of BCT for pre-operatively identifying spinal fusion patients with osteoporosis who are at high risk of reoperation or vertebral fracture.

Study design:

Observational cohort study in a multi-center integrated managed care system using existing data from patient medical records and imaging archives.

Patient sample:

We studied a randomly sampled subset of all adult patients who had any type of primary thoracic (T4 or below) or lumbar fusion between 2005-2018. For inclusion, patients with accessible study data needed a pre-op CT scan without intravenous contrast that contained images (before any instrumentation) of the upper instrumented vertebral level.

Outcome measures:

Reoperation for any reason (primary outcome) or a newly documented vertebral fracture (secondary outcome) occurring up to five years after the primary surgery.

Methods:

All study data were extracted using available coded information and CT scans from the medical records. BCT was performed at a centralized lab blinded to the clinical outcomes; patients could test positive for osteoporosis based on either low values of bone strength (vertebral strength ≤ 4,500 N women or 6,500 N men) and/or bone mineral density (vertebral trabecular bone mineral density ≤ 80 mg/cm³ both sexes). Cox proportional hazard ratios were adjusted by age, presence of obesity, and whether the fusion was long (4 or more levels fused) or short (3 or fewer levels fused); Kaplan-Meier survival was compared by the log rank test. This project was funded by NIH (R44AR064613) and all physician co-authors and author 1 received salary support from their respective departments. Author 6 is employed by, and author 1 has equity in and consults for, the company that provides the BCT test; the other authors declare no conflicts of interest.

Results:

For the 469 patients analyzed (298 women, 171 men), median follow-up time was 44.4 months, 11.1% had a reoperation (median time 14.5 months), and 7.7% had a vertebral fracture (median time 2.0 months). Overall, 25.8% of patients tested positive for osteoporosis and no patients under age 50 tested positive. Compared to patients without osteoporosis, those testing positive were at almost five-fold higher risk for vertebral fracture (adjusted hazard ratio 4.7, 95% confidence interval = 2.2-9.7; p<0.0001 Kaplan-Meier survival). Of those positive-testing patients, those who tested positive concurrently for low values of both bone strength and bone mineral density (12.6% of patients overall) were at almost four-fold higher risk for reoperation (3.7, 1.9-7.2; Kaplan-Meier survival p<0.0001); the remaining positive-testing patients (those who tested positive for low values of either bone strength or bone mineral density but not both) were not at significantly higher risk for reoperation (1.6, 0.7-3.7) but were for vertebral fracture (4.3, 1.9-10.2). For both clinical outcomes, risk remained high for patients who underwent short or long fusion.

Conclusion:

In a real-world clinical setting, BCT was effective in identifying primary spinal fusion patients aged 50 or older with osteoporosis who were at elevated risks of reoperation and vertebral fracture.