Treatment of Vertebral Compression Fracture
Chronic symptoms do not tend to respond to the management strategies for acute pain such as bed rest, immobilization or bracing device, and analgesic medication, sometimes including narcotic analgesics. The source of chronic pain after vertebral compression fracture may not be from the vertebra itself but may be predominantly related to strain on muscles and ligaments secondary to kyphosis. This type of pain frequently does not improve with analgesics and may be better addressed through exercise or physical therapy. Improvements in pain and ability to function are the principal outcomes of interest for the treatment of osteoporotic fractures.
Treatment of Sacral Insufficiency Fractures
Similar interventions are used for sacral fractures and include bed rest, bracing, and analgesics. Initial clinical improvements may occur quickly; however, resolution of all symptoms may not occur for nine (9) to 12 months.
Vertebral and Sacral Body Metastasis
Metastatic malignant disease of the spine generally involves the vertebrae/sacrum, with pain being the most frequent complaint.
Treatment of Vertebral and Sacral Body Metastasis
While radiotherapy and chemotherapy are frequently effective in reducing tumor burden and associated symptoms, pain relief may be delayed days to weeks, depending on tumor response. Further, these approaches rely on bone remodeling to regain strength in the vertebrae/sacrum, which may necessitate supportive bracing to minimize the risk of vertebral/sacral collapse during healing. Improvements in pain and function are the primary outcomes of interest for treatment of bone malignancy with percutaneous vertebroplasty or sacroplasty.
Surgical Treatment Options
Vertebroplasty is a surgical procedure that involves the injection of synthetic cement (e.g., polymethylmethacrylate, bis-glycidal dimethacrylate [Cortoss]) into a fractured vertebra. It has been suggested that vertebroplasty may provide an analgesic effect through mechanical stabilization of a fractured or otherwise weakened vertebral body. However, other mechanisms of effect have been postulated, including thermal damage to intraosseous nerve fibers.
Sacroplasty evolved from the treatment of insufficiency fractures in the thoracic and lumbar vertebrae with vertebroplasty. The procedure, essentially identical to vertebroplasty, entails guided injection of polymethylmethacrylate through a needle inserted into the fracture zone. Although first described in 2000 as a treatment for symptomatic sacral metastatic lesions, it is most often described as a minimally invasive alternative to conservative management for sacral insufficiency fractures.
Pain and function are subjective outcomes and, thus, may be susceptible to placebo effects. Furthermore, the natural history of pain and disability associated with these conditions may vary. Therefore, controlled comparison studies would be valuable to demonstrate the clinical effectiveness of vertebroplasty and sacroplasty over any associated nonspecific or placebo effects and to demonstrate the effect of treatment compared with alternatives such as continued medical management.
In all clinical situations, adverse events related to complications from vertebroplasty and sacroplasty are the primary harms to be considered. Principal safety concerns relate to the incidence and consequences of leakage of the injected polymethyl methacrylate or another injectate.
Summary of Evidence
For individuals who have symptomatic osteoporotic vertebral fractures between six (6) weeks and one (1) year old who receive vertebroplasty, the evidence includes two (2) randomized sham-controlled trials, nonblinded RCTs comparing vertebroplasty with conservative management, and several meta-analyses. Relevant outcomes are symptoms, functional outcomes, quality of life, hospitalizations, medication use, and treatment-related morbidity. Despite the completion of multiple RCTs, including two (2) with sham controls, the efficacy of vertebroplasty for painful osteoporotic compression fractures remains uncertain. Two meta-analysis studies, which included the two (2) sham-controlled trials, have demonstrated mixed results. The two (2) studies had methodologic issues, including the choice of sham procedure and the potential of the sham procedure to have a therapeutic effect by reducing pain. Questions have also been raised about the low percentage of individuals screened who participated in the trial, the volume of polymethylmethacrylate injected, and the inclusion of individuals with chronic pain. Other meta-analyses had numerous limitations due to the heterogeneity of included studies or not specifying the timeframe for osteoporotic vertebral compression fractures. Overall, conclusions about the effect of vertebroplasty remain unclear. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.
For individuals with symptomatic osteoporotic vertebral fractures less than six (6) weeks old who receive vertebroplasty, the evidence includes a randomized sham-controlled trial and nonblinded RCTs comparing vertebroplasty with conservative management. Relevant outcomes are symptoms, functional outcomes, quality of life, hospitalizations, medication use, and treatment-related morbidity. For acute fractures, conservative therapy consisting of rest, analgesics, and physical therapy is an option, and symptoms will resolve in a large percentage of individuals with conservative treatment only. However, a sham-controlled randomized trial in individuals who had severe pain of fewer than six (6) weeks in duration found a significant benefit of vertebroplasty for the treatment of osteoporotic vertebral fracture at the thoracolumbar junction. Other RCTs without sham controls have reported that vertebroplasty is associated with significant improvements in pain and reductions in the duration of bed rest. Given the high morbidity associated with extended bed rest in older adults, this procedure is considered to have a significant health benefit. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.
For individuals with sacral insufficiency fractures who receive sacroplasty, the evidence includes two (2) prospective cohort studies and a case series. Relevant outcomes are symptoms, functional outcomes, quality of life, hospitalizations, medication use, and treatment-related morbidity. No RCTs have been reported. The prospective cohort studies and retrospective series of 243 individuals have reported rapid and sustained decreases in pain following percutaneous sacroplasty. Additional literature has mostly reported immediate improvements following the procedure. However, due to the small size of the evidence base, the harms associated with sacroplasty have not been adequately studied. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.