• Neal H Shonnard, Sigurd Berven, Paul A Anderson, Evert Verschuyl, Justine Norwitz, Nell Shonnard, Sara Khor, Derrick D Wagoner, Edward S Yoon, and Douglas P Beall.
• Rainier Orthopedic Institute, Puyallup, WA.
• Pain Physician. 2020 Jul 1; 23 (4): E343-E352.

BackgroundThe BenchMarket Medical (BMM) Vertebral Compression Fracture (VCF) Registry, now known as Talosix, is a collaborative effort between Talosix (the authorized registry vendor), Noridian Healthcare Solutions, and clinicians to gather outcomes evidence for cement augmentation treatments in patients with acute painful osteoporotic VCFs. The VCF Registry was designed to provide outcomes evidence to inform the Medicare payer's "coverage with evidence development" decision to authorize reimbursement for cement augmentation treatments.ObjectivesThe purpose of this article was to present a pathway for appropriate use of vertebral augmentation based on the findings of the VCF Registry.Study DesignProspective observational data, including patient characteristics, diagnosis, process of care, and patient-reported outcomes (PROs) for pain and function, were collected from patients undergoing cement augmentation treatment. The PROs were collected at baseline, 1, 3, and 6 months following the procedure.SettingThe VCF Registry is a national ongoing registry with no specified end time or designated sample size.MethodsPrimary outcomes were pain improvement measured using the Numeric Rating Scale and function improvement, measured using the Roland Morris Disability Questionnaire (RMDQ). Secondary outcomes included cement leakage, new neurologic deficits, adverse events, readmissions, and death.ResultsThe VCF Registry delivered outcomes data to support Noridian's "coverage with evidence development" decision. A total of 732 patients were included in this study. Registry outcomes confirmed postmarket evidence of highly significant pain relief with mean pain score improvement of 6.5/10 points at 6 months. Function also improved significantly with mean RMDQ score change of 11.4/24 points 6 months after surgery. Results also showed the safety and reliability of cement augmentation.LimitationsThe nature of the registry data is that it contains nonrandomized, nonplacebo controlled data and should not be perceived as such. The real-world setting and the large number of patients within the dataset should increase the external validity of the findings.ConclusionsCement augmentation treatments of patients with acute painful VCFs reliably results in highly significant benefits of pain decrease and functional improvement for this Medicare population.Key WordsVertebral compression fractures, osteoporosis, kyphoplasty, back pain, registry.

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