Introduction
Osteoporotic compression fractures (OCFs) are the most common osteoporotic fracture among the aging population, comprising 27% of all osteoporotic fractures [
1]. They represent a large economic burden on the healthcare system. In 2015, OCFs had an incidence of 102.1 per 10,000 Medicare beneficiaries, costing approximately $658 million [
2]. Of these patients, 35% required acute hospitalization within 7 days following OCF, and 61% required hospitalization greater than 8 days after OCF. Furthermore, the 1-year mortality rate following OCF among Medicare beneficiaries was 21%.
Recent literature has focused on treating OCFs. Operative management consists of percutaneous vertebral augmentation (PVA), including vertebroplasty and kyphoplasty, whereas nonoperative management consists of pain management and external orthoses [
3]. Several randomized controlled trials did not show a significant clinical benefit regarding pain or functional outcomes with vertebroplasty [
4–
7]. In contrast, several studies have found that in the aged population, vertebroplasty offers improved functional outcomes and morbidity and mortality benefits [
8,
9]. It is not currently recommended in national clinical guidelines for treating OCFs.
Several studies have been conducted to elucidate the benefits of kyphoplasty versus nonoperative treatment for OCFs. Numerous studies have shown that kyphoplasty offers greater improvement in daily activities, quality of life, and vertebral deformity than conservative treatment [
10,
11]. Patients treated operatively have also been found to have improved mortality benefit [
12]. Currently, clinical practice guidelines weakly recommend kyphoplasty [
13].
However, the number of studies examining and comparing acute complication rates between operative and nonoperative management of these fractures in patients hospitalized for OCFs is limited. This study was designed to determine whether acute PVA alters morbidity compared with nonoperative management.
Results
Cohort matching resulted in 14,850 patients who underwent operative treatment and 29,700 patients who underwent nonoperative treatment. The mean age of the patients in the operative (79.3% female) and nonoperative (82.9% female) treatment groups was 79.7 years and 79.6 years, respectively. All demographic and hospitalization characteristics are comprehensively outlined in
Table 3.
On univariate analysis, the operative group demonstrated significantly lower rates of respiratory complications, such as pulmonary embolism (PE) (odds ratio [OR], 0.68; 95% confidence interval [CI], 0.56–0.83; p<0.001), pneumonia (OR, 0.63; 95% CI, 0.59–0.68; p<0.001), and acute respiratory failure (OR, 0.84; 95% CI, 0.78–0.91; p<0.001). Operative treatment was also associated with a significantly lower risk of cardiac complications, including myocardial infarction (MI) (OR, 0.34; 95% CI, 0.28–0.42; p<0.001), cardiac arrest (OR, 0.52; 95% CI, 0.35–0.78; p=0.001), acute heart failure (OR, 0.82; 95% CI, 0.75–0.89; p<0.001), and cardiogenic shock (OR, 0.40; 95% CI, 0.23–0.70; p<0.001); moreover, lower rates of cerebral infarction (OR, 0.61; 95% CI, 0.49–0.77; p<0.001) were observed among patients undergoing operative treatment. The rates of infectious sequelae, including sepsis (OR, 0.42; 95% CI, 0.37–0.46; p<0.001) and septic shock (OR, 0.58; 95% CI, 0.46–0.73; p<0.001), were also significantly lower in the operative treatment group. Moreover, the occurrence of pressure ulcers (OR, 0.69; 95% CI, 0.61–0.78; p<0.001) and urinary tract infections (UTI) (OR, 0.92; 95% CI, 0.88–0.97; p=0.001) was significantly decreased in the operative group compared with that in the nonoperative group. Conversely, patients undergoing operative treatment were more likely to experience acute renal failure (OR, 1.10; 95% CI, 1.04–1.16; p=0.001) and radiculopathy (OR, 1.25; 95% CI, 1.09–1.43; p=0.002) than those undergoing nonoperative treatment.
On multivariate analysis, operative treatment continued to demonstrate a significantly decreased risk of complications as previously observed. Significantly lower rates of pneumonia (OR, 0.75; 95% CI, 0.67–0.84;
p<0.001) and acute respiratory failure (OR, 0.84; 95% CI, 0.74–0.96;
p=0.009) persisted in the operative group. The risk of cardiac complications, including MI (OR, 0.20; 95% CI, 0.15–0.26;
p<0.001), acute heart failure (OR, 0.80; 95% CI, 0.69–0.91;
p=0.001), and cardiogenic shock (OR, 0.23; 95% CI, 0.10–0.53;
p=0.001) remained significantly lower in the operative group, as did the rate of cerebral infarction (OR, 0.44; 95% CI, 0.32–0.62;
p<0.001). Operative treatment continued to demonstrate a significantly decreased risk of infectious sequelae, specifically sepsis (OR, 0.39; 95% CI, 0.34–0.45;
p<0.001) and septic shock (OR, 0.50; 95% CI, 0.37–0.67;
p<0.001), compared with nonoperative treatment. The incidence of pressure ulcers (OR, 0.71; 95% CI, 0.60–0.85;
p<0.001) remained significantly lower in the operative group as well. The only complication that had a higher rate in the operative group was acute renal failure (OR, 1.19; 95% CI, 1.08–1.31;
p<0.001). No significant differences in the incidence of deep vein thrombosis, PE, cardiac arrest, UTI, and radiculopathy were observed between the two groups. All complication rates and corresponding significance values are listed in
Table 4.
Operative treatment was associated with a higher mean total cost of admission and mean LOS at $76,030 and 6.73 days, respectively, compared with nonoperative treatment at $46,257 and 5.54 days, respectively (both
p<0.001). Among patients who underwent operative treatment, 69.5% were admitted to a metropolitan teaching hospital, 24.4% were admitted to a metropolitan nonteaching hospital, and 6.03% were admitted to a rural hospital compared with 66.1%, 23.2%, and 10.7%, respectively, in the nonoperative group (
p<0.001). Overall, nonoperative treatment was associated with a significantly greater in-hospital mortality rate at 2% than operative treatment at 0.67% (
p<0.001) (
Table 3).
Discussion
In this study, we found that patients hospitalized for OCFs who undergo conservative treatment have an increased rate of acute in-hospital complications, including respiratory complications, cardiac complications, sepsis, and pressure ulcerations, compared with those who undergo acute PVA within 1 week. After PVA, patients are encouraged to mobilize and have been shown to have decreased pain [
4,
14,
15]. Mobilization significantly alters the morbidity and mortality rates [
16,
17]. This may explain the increased rate of acute complications seen in patients who underwent conservative treatment in this study. Contrarily, patients who undergo PVA have a higher rate of acute renal failure. Acute renal failure is a known postoperative complication, explaining the increased risk in patients treated operatively [
18–
21].
Our findings are supported by several studies that examined the morbidity and mortality benefits of kyphoplasty and vertebroplasty. Eddin et al. [
12] have found that both kyphoplasty and vertebroplasty offer improved mortality benefits compared with nonoperative treatment at up to 4 years following OCF in a national database study. A meta-analysis by Yuan et al. [
22] has found that vertebroplasty and kyphoplasty improve quality of life, pain, and functional outcomes. Yang et al. [
8] have reported that early vertebroplasty in the aged population offered faster and better pain relief and improved functional outcomes with lower complication rates than conservative therapy. Similarly, Lin et al. [
9] have found improved morbidity and mortality with acute versus subacute vertebroplasty in the aged population. Clark et al. [
14] have recently published a randomized controlled trial, which showed that vertebroplasty is superior to sham vertebroplasty in reducing pain, improving functional outcome scores, and decreasing analgesic use up to 6 months following OCF.
In a prospective study, Hoshino et al. have found that patients treated with kyphoplasty within 2 months of a painful OCF were less likely to have a decrease in activities of daily living [
11]. Similarly, Wardlaw et al. [
10] have conducted a randomized clinical trial and found that kyphoplasty resulted in significantly greater improvements in quality of life and disability measures and reduction in back pain than nonoperative treatment in patients with acute painful vertebral fractures. These differences, however, diminished at 12 months. Our findings add to this body of literature, which indicates an improved morbidity benefit with PVA compared with nonoperative management.
Conversely, several publications refute these beneficial outcomes. In a randomized controlled trial, Firanescu et al. [
6] have found that vertebroplasty offers no improvements in pain and functional outcomes compared with a sham procedure. Kallmes et al. [
7] had similar findings in a separate randomized controlled trial with analogous methods. However, these studies assessed pain and functional outcomes and were not powered to detect differences in morbidity between the two treatment groups.
This study has several limitations. It is a national database study, so it lacks granularity on the patient level. Because of this, we could not report on fracture characteristics or radiographic parameters. An inherent selection bias exists when choosing patients for operative versus nonoperative management. A subset of patients selected for nonoperative management are likely too sick for operative treatment, despite having operative indications. While we matched our cohorts based on several comorbidities and controlled for many potential confounding factors, it is possible that we did not exclude this subset of patients. Additionally, although we believe that early mobilization may contribute to the improved morbidity benefit of acute PVA, we did not have data that support this theory because it is not recorded in the NIS database. Finally, the NIS database is an inpatient-only database, so we could not capture outpatient procedures or long-term complications following initial hospitalization.