An Interim Analysis of the First 102 Patients Treated in the Prospective Vertebral Augmentation Sacroplasty Fracture Registry

Clinical question

Is sacroplasty an effective and safe procedure for reducing pain and improving function in the treatment of patients with sacral insufficiency fractures?

Take away point

Sacroplasty effectively and safely reduced painful sacral insufficiency fractures while maintaining patient-reported outcomes over 6 months.

Reference

An Interim Analysis of the First 102 Patients Treated in the Prospective Vertebral Augmentation Sacroplasty Fracture Registry. Beall D. P et al. Journal of Vascular and Interventional Radiology, Volume 34, Issue 9, 1477 – 1484. doi.org/10.1016/j.jvir.2023.05.024

Click here for the abstract

Study design

Multicenter, prospective, single-arm registry.

Funding Source

D.P.B. reports compensation from Medtronic related to consultancy, research, and teaching; grants from Benvenue, Alphatech Spine, Medical Metrics, Liventa, Vexim, and Mesoblast; grants and personal fees from Medtronic, Halyard, Vivex, and Vertiflex; consultancy fees from Dfine and Osseon; and other from Lilly, Smith & Nephew, Biomet, Vertiflex, Synthes, and Integral Spine Solutions. N.H.S. reports compensation related to royalties from Globus and consulting, research, and teaching from Medtronic.

Setting

10 sites in the United States consisting of small community practices, radiology group practices, multispecialty group practices, and large academic medical centers.

Figure 2

Mean Numerical Rating Scale scores at the 1-, 3-, and 6-month time points.

Summary

    Sacral insufficiency fractures (SIFs) are painful fractures of the sacrum that can occur in patients with osteoporosis or neoplastic involvement. These fractures often go undiagnosed and are a common source of low back pain in elderly patients. Sacroplasty has been shown to be an effective and safe treatment for sacral fractures with minimal adverse effects. However, no prospective observational trials (registries) have reported basic safety and efficacy data. The authors performed a multicenter, prospective, single-arm registry study with 102 patients to assess the efficacy and safety of sacroplasty for the treatment of sacral insufficiency fractures.

    The study included 102 patients presenting with SIF. Patient-reported outcome (PRO) data was collected via phone call surveys at the 1-, 3-, and 6-month mark after the initial sacroplasty procedure. The PROs obtained included pain, assessed using the Numerical Rating Scale (NRS), and function, assessed using the Roland-Morris Disability Questionnaire (RMDQ). The minimal clinically important difference was defined as a change of greater than or equal to 2 points from baseline on the NRS for pain and greater than or equal to 5 points from baseline on the RMDQ for function. The secondary endpoints were cement leakage, adverse effects, hospital readmission, new neurologic deficits, and death.

    Patients were analyzed using frequencies for categorical variables and means for continuous variables, while PROs were reported at baseline, 1, 3, and 6 months. Generalized estimating equation models were used to analyze the effects of time on repeated measurements for pain and function. Post hoc tests with Bonferroni adjustments were used to compare the mean differences between PROs.

    The most common treated levels were both S1 and S2, and prior to cement augmentation, nonsurgical management was attempted in 93.1% of the patients, and 78.4% of patients with sacral fractures had an osteoporosis diagnosis. The study demonstrated statistically significant (P < .001) improvements in NRS and RMDQ scores at 6 months compared to baseline. Mean RMDQ scores decreased from 17.7 to 5.2 over a 6-month period and mean NRS scores decreased from 7.8 to 0.9 over the same period. Out of the 102 patients, only one experienced an adverse effect of cement extravasation leading to new neurologic deficits. Cement leakage was observed in 17.7% of the patients but remained asymptomatic except for one patient with new-onset neurological deficits. There were no patient deaths, and hospital readmission after sacroplasty occurred in 8 of the 102 patients (7.8%) at 6 months and one patient each after 1 and 3 months.

Commentary

    The purpose of the study was to provide prospective observational data on the efficacy and safety of sacroplasty for treating sacral insufficiency fractures using patient-reported outcomes. The study used a prospective registry approach, enabling the collection of real-world data from a diverse patient population across the United States. Considering the inherent limitations of a registry study the methods and study approach was well-structured. The statistical model and equation models used to analyze the data appear to be appropriate. However, the study does not provide further detail on the statistical analysis process. The presented outcomes are convincing, indicating significant improvements in pain and function following sacroplasty in SIF patients. The study’s results align with data from previous studies and meta-analyses. Areas of improvement include a clearer explanation of the statistical analyses and independent radiographic evaluations of patients. Overall, the paper provides compelling evidence that support the safety and efficacy of sacroplasty for patients with SIF.

Post author

Aric Patel, MS
University of New England College of Osteopathic Medicine