Is Vertebral Augmentation Beneficial for Compression Fractures in the Elderly?
Findings from six randomized controlled studies suggest that vertebral augmentation is efficacious for the treatment of compression fractures in elderly patients with osteoporosis, James S. Harrop, MD, told attendees at Spine Summit 2016 in Orlando, Florida.
Vertebral compression fractures contribute to a downward spiral leading to back pain, spinal deformity, impaired function, less activity, more bone loss, additional compression fractures, and pulmonary disorders, said Dr. Harrop, who is a Professor in the Departments of Neurological and Orthopedic Surgery at Thomas Jefferson University in Philadelphia, PA. In fact, the five-year mortality rate in patients with compression fractures is increased by approximately 20%, Dr. Harrop noted.1
“The best opportunity to intervene is before compression fracture occurs,” Dr. Harrop said. He stressed the importance of early diagnosis and treatment of osteoporosis to prevent vertebral compression fractures from occurring, and noted that the single greatest risk factor for a vertebral compression fracture is a previous compression fracture.
In addition, he emphasized the need to properly screen patients at risk for osteoporosis using bone density scanning, particularly given that approximately two-thirds of patients with vertebral compression fractures are asymptomatic.
Surgical and Nonsurgical Treatment Options
In the 2010 guidelines from the American Academy of Orthopaedic Surgeons (AAOS), calcitonin was the only treatment recommended as having a “moderate” level of evidence supporting efficacy in the treatment of symptomatic osteoporotic spinal compression fractures.2 The AAOS recommended against vertebroplasty in patients who are neurologically intact and considered kyphoplasty to be a “weak” option.
Unfortunately, some patients with vertebral compression fractures lose neurologic function and require surgery. “If you don’t operate on these patients, many will go downhill,” Dr. Harrop said.
In patients who require surgery for vertebral compression fracture, Dr. Harrop prefers to use multiple points of fixation, not ending the construct within kyphotic segments, and accepting lesser degrees of sagittal alignment.
When considering the approach to surgery for osteoporotic vertebral collapse, Dr. Harrop referred to a retrospective study by Uchida et al showing no significant difference in kyphotic angle at follow-up between patients (N=50) who received an anterior versus posterior approach to surgery.3 In addition, no difference in neurologic outcomes or complication rate was found between the two groups.
Vertebroplasty Versus Kyphoplasty: Which is Better?
In a comparison of data from 6 randomized controlled trials of vertebroplasty or kyphoplasty (Table), Dr. Harrop noted that the improvement in pain score was slightly greater with vertebral augmentation, but not remarkably so.4-9
“The interesting thing is that there is probably not a huge difference between vertebroplasty and kyphoplasty,” Dr Harrop said. While vertebroplasty may have an early benefit over kyphoplasty, kyphoplasty may have better efficacy overall, he noted.
Kallmes et al Trial
Dr. Harrop highlighted data from 3 of these trials. In the Kallmes et al study, the control group received an alternative procedure involving a local anesthetic injected into the skin periosteum, as well as pressure and polymethylmethacrylate (PMMA) mixed to mimic the vertebroplasty procedure.6 Dr. Harrop noted that the psychological benefit of using a nonoperative intervention (rather than a sham procedure) allowed the control group to do “unbelievably well” at 1-month follow-up in terms of improved pain rating.
“If you don’t prove your hypothesis, that doesn’t necessarily mean it is wrong; it means you didn’t prove your hypothesis for multiple reasons,” Dr. Harrop said. In addition to the lack of a true control group, Dr. Harrop pointed out several other limitations of the study: 1) fracture age was nebulous; 2) only 131 enrolled in the study out of 1,812 patients who were screened, indicating a possible selection bias; and 3) the location of back pain was not well-defined.
Another point of interest is that more patients in the control group chose to cross over to the vertebroplasty group at 1-month follow-up. Dr. Harrop noted that this may indicate that patients in the control group may have had poorer outcomes that were not recognized using the outcomes measures chosen for this study that vertebroplasty is better for a certain unrecognized subgroup of patients, or that patients learned they received a control group and chose to receive surgery instead.
Klazen et al Trial
The open-label prospective randomized trial known as VERTOS II supported the use of vertebroplasty, Dr. Harrop said.8 The mean improvement in visual analogue pain score showed a significant benefit of vertebroplasty both at 1 month and 1 year (P<0.0001 at both time points). No serious adverse events or serious complications were reported in this study.
Wardlow et al Trial
In a randomized controlled multicenter study of kyphoplasty versus nonoperative care, Wardlaw et al found that kyphoplasty resulted in a mean improvement of 3.5 points over the control group (P<0.004).5 The study included younger patients (age 21 and older), used effective outcome metrics (the Short-Form 36 Physical Component Summary) and had excellent follow-up rates (92% and 85% of the intervention and control groups, respectively, completed follow-up at 1 month), Dr. Harrop said.
“This study gets criticized because it included tumor patients,” Dr. Harrop said. “However, only two patients in this study had tumors, so it is actually an exceptionally well done study. The primary and secondary outcomes were significant in favor for kyphoplasty,” he added.
Together, the data from these 6 randomized controlled trials, published in highly regarded journals suggest that surgical treatment in the form of vertebral augmentation is effective in the treatment of osteoporotic vertebral compression fractures, Dr. Harrop concluded.