Treatment of Painful Vertebral Fractures by Kyphoplasty in Patients With Primary Osteoporosis: A Prospective Nonrandomized Controlled Study

Abstract

This study investigates the effects of kyphoplasty on pain and mobility in patients with osteoporosis and painful vertebral fractures compared with conventional medical management.Introduction: Pharmacological treatment of patients with primary osteoporosis does not prevent pain and impaired activity of patients with painful vertebral fractures. Therefore, we evaluated the clinical outcome after kyphoplasty in patients with vertebral fractures and associated chronic pain for >12 months. Materials and Methods: Sixty patients with primary osteoporosis and painful vertebral fractures presenting for >12 months were included in this prospective, nonrandomized controlled study. Twenty-four hours before performing kyphoplasty, the patients self-determined their inclusion into the kyphoplasty or control group so that 40 patients were treated with kyphoplasty, whereas 20 served as controls. This study assessed changes in radiomorphology, pain visual analog scale (VAS) score, daily activities (European Vertebral Osteoporosis Study [EVOS] score), number of new vertebral fractures, and health care use. Outcomes were assessed before treatment and at 3 and 6 months of follow-up. All patients received standard medical treatment (1g calcium, 1000 IE vitamin D 3 , standard dose of oral aminobisphosphonate, pain medication, physical therapy). Results: Kyphoplasty increased midline vertebral height of the treated vertebral bodies by 12.1%, whereas in the control group, vertebral height decreased by 8.2% (p ‫ס‬ 0.001). Augmentation and internal stabilization by kyphoplasty resulted in a reduction of back pain. VAS pain scores improved in the kyphoplasty group from 26.2 ± 2 to 44.2 ± 3.3 (SD; p ‫ס‬ 0.007) and in the control group from 33.6 ± 4.1 to 35.6 ± 4.1 (not significant), whereas the EVOS score increased in the kyphoplasty group from 43.8 ± 2.4 to 54.5 ± 2.7 (p ‫ס‬ 0.031) and in the control group from 39.8 ± 4.5 to 43.8 ± 4.6 (not significant). The number of back pain-related doctor visits within the 6-month follow-up period decreased significantly after kyphoplasty compared with controls: mean of 3.3 visits/patient in the kyphoplasty group and a mean of 8.6 visits/patient in the control group (p ‫ס‬ 0.0147). Conclusions:The results of this study show significantly increased vertebral height, reduced pain, and improved mobility in patients after kyphoplasty. Kyphoplasty performed in appropriately selected osteoporotic patients with painful vertebral fractures is a promising addition to current medical treatment.

Comparing effects of kyphoplasty, vertebroplasty, and non-surgical management in a systematic review of randomized and non-randomized controlled studies

“…Included Articles N=27 of the studies reported effects for the same group of patients and were combined into one analyzable ''study'' (Kasperk/Grafe et al, 4 total [11,12,24,25] and Rousing et al, 2 total [20,26]; see Table 1). This systematic review was reported in accordance with the PRISMA statement [27].…”

“…Both the BKP group (I 2 = 96) and the VP group (I 2 = 96) have substantial heterogeneity. Most BKP studies reporting 3.78-88 reduction, with 2 outliers that showed minimal change [12,39]. Results are summarized in Table 5, which compares mean values (where applicable) between RCTs, non-RCTs and pooled studies.…”

“…The BKP arm was more heterogeneous, but this was due to the presence of two studies that paradoxically report significant VB height restoration with no change in kyphosis [12,39]. This finding likely reflects the correction of biconcave fractures that are not associated with the development of kyphotic angulation.…”

“…There is class I evidence to support the superiority of vertebral augmentation procedures (VAPs) over NSM [8][9][10], as well as non-randomized prospective studies [11][12][13], systematic reviews [14][15][16][17][18][19], and numerous retrospective series supporting safety and effectiveness of these procedures. However, recently published randomized controlled trials (RCTs) that showed no superiority of VP over NSM [20] or over a simulated procedure (sham) [21,22] have raised questions regarding the value of VP.…”

Comparison of 5766 Vertebral Compression Fractures Treated With or Without Kyphoplasty

“…In kyphoplasty, an inflatable bone tamp is used to prepare a confined space for PMMA injection [40]. Both techniques reportedly relieve fracture pain and improve functional outcome at both short-and long-term followup [2,14,25,35,40,41]. The procedure is not without risk, however.…”