In this systematic review, we included all retrievable prospective controlled trials that compared percutaneous cement augmentation to conservative treatment or placebo in the management of OVFs in the elderly. Pooled results indicate significant pain relief and functional improvement up to 12 months of follow-up for percutaneous cement augmentation compared to conservative treatment.
Consensus guidelines about the role of percutaneous cement augmentation in OVFs are lacking, and divergent opinions exist. In the European Guidance for the diagnosis and management of osteoporosis in postmenopausal women, a role for percutaneous cement augmentation has been suggested in patients with recent OVF in whom pain persists for 2–3 weeks despite a well-conducted analgesic program . In accordance with the European guidance, the UK NICE guidelines recommend percutaneous cement augmentation only in patients who have severe ongoing pain after a recent, unhealed fracture despite optimal pain management . The American Academy of Orthopaedic Surgeons strongly recommends against vertebroplasty based on evidence regarding two Level I studies that compared vertebroplasty to a sham procedure and showed no significant difference between the two procedures in pain relief and function . However, these two studies have been criticized thoroughly [32, 33]: Both studies included patients with symptoms of up to 1-year duration, which is a time period in which fractures can heal naturally. Moreover, patients with an NRS score of three points out of ten were eligible for inclusion. Ryu and Park reported that there is a strong correlation between severity of pre-intervention pain score and the post-intervention outcome; more severe pain resulted in more significant improvement following PV . The low participation rates of eligible patients and high crossover rates in both studies have also been questioned. In the study of Kallmes et al., at 3-month follow-up, many patients in the control group (43%) crossed over to the PV group due to persisting pain, as compared to the number of patients in the PV group who crossed over to the control group (12%), a difference that reached statistical significance (p < 0.001). Finally, patients assigned to the sham procedures received injection of Bupivacaine into the periosteum next to the facet joints. However, in a study of Tischer et al., degenerative facet joint lesions were found on gross histologic analysis in 80% of the elderly, with most found at the L4–L5 level . In the Framingham Heart Study, moderate or severe lumbar facet joint osteoarthritis on CT-imaging was present in 89% of those above 65 years of age . Pain improvement rates after facet blocks or an medial branch block in patients with back pain has been reported in the range of 29–60% in the literature . Park et al. reported a satisfaction level of “excellent” or “good” 12 months after the first injection in 78.9% of the patients with osteoporotic spinal compression complaining of persistent low back pain . In the series of Heui Seung Lee and the study of Kim et al., 69.6% and 70% of the patients have benefitted from a medial branch block for their back pain, respectively [39, 40]. In our systematic review, a tertiary analysis with a random effects model showed a substantial within-group reduction in VAS score of 3.6 (95% CI: 1.2; 3.0, p < 0.001, I2 = 93.0%) in a 6-month follow-up period for the sham groups. A blinded RCT studying the outcome of facet blocks against percutaneous cement augmentation in the elderly would be of great value.
Because of the results of the two sham trials of 2009, in some countries PV/PKP were not reimbursed anymore . Ong et al. showed us that the mortality risk for VFC is high. In this study, more than two million patients were analyzed and the mortality in the overall VFC cohort was 85.1 (95% CI 84.7–85.5) at 10 years. The conservative-treated group showed a 24% and 8% larger mortality risk than the PKP and PV, respectively. The mortality of patients was also significantly greater in the period 2010–2014 compared to 2005–2009 .
A more recently published blinded Australian trial comparing PV to placebo treating patients with a less than 6 weeks old fracture showed a larger mean reduction in pain in the PV group than in the placebo control group at all follow-up moments . The patients in this trial were older, had higher pain scores and increased disability at enrollment than those patients in previous placebo-controlled trials. In contrast to previous trials in which the posterior vertebral cortex was anesthetized, this trial used local anesthesia subcutaneously. Also, this trial used odorless PMMA kits with a closed mixing and delivery system that was not opened during placebo procedures. Additionally, in this trial there was the absence of a crossover option and 57% of patients were in-hospital patients, in contrast to the other placebo-controlled trials which excluded or did not report on these patients. A median reduction in 5.5 hospital days was achieved in the PV group of the VAPOUR trial. This trial has been criticized for its lack of generalizability and methodological flaws. On average, 84% of the patients were recruited from one institute, while the study was performed as a multicentre trial. Besides, comorbidities in the studied cohorts were not recorded and most subgroup analyses had a limited number of patients achieving outcome. The differences in results for primary outcomes of the placebo-controlled studies could be explained by inclusion criteria and study methodology.
The Cochrane vertebroplasty review of April 2018 was updated in November 2018 to address complaints to the Chief Editor of Cochrane about errors in the report . There is ongoing debate that the review does not accurately report the evidence for vertebroplasty in patients with severe symptoms and early fractures.
The importance of early interventions positively affecting final outcome has already been studied in hip fractures, which have been traditionally regarded to represent frailty. A Canadian cohort of 42.230 patients with a mean age of 80 years found significant benefits of early surgery. Significantly lower 30-day mortality (5.8% vs. 6.5%), less postoperative complications and significantly less adverse outcomes at 30 days (10% vs. 12%) were found with early surgery (< 24 h) . Appropriate attention and early management are also needed for frail patients with OVFs because of reciprocal interaction. Frailty deficits worsen by fracture, and accelerated risk of OVFs arises by frailty . Delaying surgical intervention in the fragile elderly can sometimes lead to suboptimal care. The results of recent RCTs suggest a shift to an earlier and more aggressive approach in the form of percutaneous cement augmentation instead of conservative treatment for acute and subacute thoracolumbar fractures in the elderly [11, 12].
Moreover, delayed diagnosis and lack of proactive management may result in a vicious circle with recurrent or prolonged hospitalization, acute and chronic back pain, polypharmacy with painkillers (often poorly tolerated by the elderly population), reduced pulmonary function, failure in overall sagittal compensation and progressive spinal kyphosis with consequent loss of function and independency and potential premature death. Furthermore, severe osteoporosis and aging are risk factors for failure of conservative treatment [23, 45]. In the study of Lee et al., a cutoff value of 76.5 years old was a risk factor for failure. The failure rate for early (3 weeks) conservative treatment was 35% in this study. Zhang et al. showed that a modified frailty index (mFI) of > 3 and severe osteoporosis were important risk factors for conservative treatment failure. The failure rate was 41% for early (3 weeks) conservative treatment.
In summary, many authors suggest to choose for conservative treatment in the early weeks after OVFs. Minimal invasive treatments like PV and PKP are indicated if conservative treatment fails. Elderly patients with osteoporotic fractures should be considered as frail elderly. In the frail elderly, prolonged non-effective conservative management can lead to a patient becoming bedridden with a range of complications and even premature death as a consequence. Besides, the increasing danger of opioid abuse should be recognized.
This systematic review is limited by the significant heterogeneity and moderate quality evidence of included studies. Potential bias cannot be excluded due to inadequate blinding of patients and personnel. In some studies, the control groups were formed by the population that rejected percutaneous cement augmentation, which introduces selection bias. Besides, conservative treatment characteristics varied considerably: offering bed rest, analgesia, a variation of rehabilitation program or brace treatment, and in one study, even intrathecal infusion was offered. In addition, outcome measures varied between studies. Adverse events of the procedures were not described in detail since most studies mainly focused on pain or function.
In this review, we conclude that in the frail elderly with (sub)acute OVF, severe pain despite early conservative measures, focal tenderness and edema on MRI scans concordant with the level of the fracture, when no absolute contraindications are present, percutaneous cement augmentation is safe and effective and can be offered to hasten return to normal function and bypass the consequences of prolonged immobilization. Given the limited methodological quality of included studies, the present findings should be confirmed with more high-quality and well-designed studies.