Randomized studies demonstrate significant reduction in patient-reported outcome measures in patients with malignant disease and painful vertebral lesions compared to conservative treatment. The risk of symptomatic cemental leaks in patients with fracture of the posterior wall of the vertebral body is not described in any publications.
To our knowledge, this is the first guideline evaluating treatment efficacy on cancer-related painful vertebral lesions. This guideline demonstrates significant improvement in pain, quality of life, and mobility.
In 2019, a systematic review on the same topic was published . This review included not only randomized studies, but also other publications involving vertebral augmentation techniques. In all, 87 studies were included in the study and a meta-analysis was performed. The review demonstrated clinically relevant improvement in VAS, ODI, and KPS. The results from the review support the conclusion in this guideline.
This guideline and the review find a high level of cemental leaks, but symptomatic complications are rare. We did not find any study demonstrating a higher risk of cemental leaks into the spinal canal in case of fracture of the posterior wall. However, care should always be taken while injecting the cement, to decrease the risk of cemental leak into the spinal canal and to avoid escape of cement to the venous system leading to pulmonary cemental embolies. Injecting the cement should be performed under continues radiation.
The major limitation of this guideline is the sparse number of randomized studies.
Furthermore, we did not distinguish between kyphoplasty and vertebroplasty, the number of levels treated, the volume of injected cement, and type of malignant disease. The effect of the procedure and risk of complications may depend on parameters mentioned above.
To find any differences in patient-reported outcome measures in patients with these parameters when comparing cemental augmentation with conservative treatment, randomized studies with a higher number of included patients are necessary.
The primary purpose of vertebral augmentation, especially in patients with malignant disease, is fast and effective pain relief, and in this case, the type of cancer and the prognosis for survival might be less relevant.
We are not aware of evidence describing any correlation between the volume of injected cement and level of pain reduction. In order to avoid complications, the injection of cement is ceased when cemental leaks are observed. The final injected volume depends on both the initial volume of the fractured vertebral body and on any leaks observed.
We expect that the majority of patients with malignant disease and painful vertebral lesions will accept cemental augmentation. Reduction in pain for these patients is of great importance. In addition, the risk of symptomatic complications is low. Life expectancy for these patients may be short, and pain is a major impact factor on quality of life.
To confirm the conclusion in this guideline, more randomized studies on patients with different malignant diseases and painful vertebral lesions comparing percutaneous vertebroplasty/kyphoplasty with conservative treatment are needed. If possible, double-blinded studies should be performed in order to avoid confounders and risk of bias.