Evidence-Based Physiatry: Cochrane Corner
The aim of this commentary is to discuss, from a rehabilitative perspective, the recently published Cochrane Review “Percutaneous vertebroplasty for osteoporotic vertebral compression fracture” by Buchbinder et al.,1 under the supervision of Cochrane Musculoskeletal Group. Cochrane Corner is produced in agreement with the American Journal of Physical Medicine and Rehabilitation by Cochrane Rehabilitation.
Vertebral compression fractures (VCFs) are the most common fractures in patients with osteoporosis,2 impacting the life of patients in short- (pain, spinal deformity, and functional impairments) and long-term periods (neurologic and pulmonary complications, lower quality of life, increased risk of further VCFs, and mortality).3 There are several conservative approaches, but the use of percutaneous vertebroplasty (PV) is proposed as the standard care for VCFs in patients nonresponsive to conservative treatment.4 Percutaneous vertebroplasty is defined as percutaneous insertion of bone cement (usually polymethyl methacrylate) with a large-caliber needle under imaging guidance into the affected vertebral body.5 Despite numerous systematic reviews and meta-analyses, evidence of its efficacy is conflicting, and many adverse events due to the procedure have been documented.
PERCUTANEOUS VERTEBROPLASTY FOR OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURE (Buchbinder et al., 2018)
What Is the Aim of the Cochrane Review?
The aim of the Cochrane Review was to assess the efficacy and safety of PV for treating patients with vertebral compression osteoporotic fractures.
What Was Studied in the Cochrane Review?
The review included 2852 patients (21 studies; mostly female; age, 62.6–81 yrs) with symptoms duration from 1 wk to more than 6 mos.
The comparison interventions were placebo (no injection, primary comparison), usual care (the best supportive care, included pharmacologic and nonpharmacologic treatments), percutaneous kyphoplasty (an expansion balloon inserted into the vertebral body before injection of bone cement), and facet joint injection of glucocorticoids.
Outcomes, measured with specific clinical scales, were related to pain (overall or proportion with a clinically relevant pain reduction), back-related disability, disease-specific and general health-related quality of life (HRQoL), treatment success (patient’s impression), presence of new clinical and new radiographic VCF, and number of serious or minor adverse events due to the procedure. In most of the included studies, these outcomes were evaluated at several assessment times (up to 24 mos).
How Up-to-Date Is This Review?
Authors have updated the results of their previous Cochrane Review published in 2015,6 including studies until November 15, 2018.
What Are the Main Results of the Review?
- Percutaneous vertebroplasty versus placebo (benefits)
- - Pain/disability/vertebral fracture, HRQoL: no evidence of clinically important differences between the groups, even if a small benefit in PV was recorded at 1 mo (pain and disability).
- Percutaneous vertebroplasty versus usual care (benefits)
- - Pain: possible greater improvements in PV for the assessments up to 12 mos, whereas no evidence of important differences between the groups at 24 mos;
- - Disability: possible improvements in PV in every assessment; and
- - Health-related quality of life/treatment success: probably no evidence of important differences between the groups.
- Percutaneous vertebroplasty versus placebo and usual care (harms)
- - Clinical and radiographic new fractures: uncertain whether there are differences in the risk of new fractures between the groups because of low number of events;
- - Serious adverse events: several trials reported serious adverse events due to the procedure (including osteomyelitis, lesion/injury of the thecal sac, cord compression, and respiratory arrest due to sedation failure among the main reported adverse events), but the difference in risks between the treatments was uncertain because of low number of events.
- Percutaneous vertebroplasty versus kyphoplasty (benefits-harms)
- - Pain/disability/general HRQoL: possibly no important differences between the groups in every assessment;
- - Clinical and radiographic new fractures: uncertain differences between the groups;
- - Serious adverse events: uncertain differences at 12 and 24 mos (device/procedure/anesthesia related/or possibly related).
- Percutaneous vertebroplasty versus facet joint injection (benefits-harms)
- - Pain/disability/HRQoL: possible improvement in PV group at 1 wk (no data for HRQoL) with no difference at other times of assessment (up to 12 mos);
- - New radiographic fractures: uncertain differences at 12 mos.
How Did the Authors Conclude on the Evidence?
In the treatment of VCFs in patients with osteoporosis, Buchbinder et al.1 noted that vertebroplasty provides little or no benefit in terms of pain, disability, disease-specific or overall quality of life, or treatment success (high- to moderate-quality evidence), compared with placebo, independently of the duration of pain before the intervention. Evidence for generic quality of life and treatment success was downgraded to moderate quality for imprecision. They also indicate uncertainty around the risk of harms with vertebroplasty compared with placebo or usual care because of imprecision and potential bias from the usual care–controlled trials. When compared with usual care, PV seems to improve the study outcomes, but this is uncertain because of bias in the studies and variation in results across trials. No important differences were recorded when PV was compared with kyphoplasty or facet joint injection. The authors concluded that it is important to inform patients with VCF that high- to moderate-quality evidence shows no important benefit of PV or its potential for harm.
Recommendations for Research by the Authors of the Cochrane Review (Buchbinder et al.)
Although future high-quality studies may reduce the uncertainty around the estimates of risk for further vertebral fracture and serious adverse events after PV, high-quality evidence from placebo-controlled trials indicates that there is likely no benefit of VP. Thus, the need for further trials is questionable.
WHAT ARE THE IMPLICATIONS OF THE COCHRANE EVIDENCE FOR PRACTICE IN REHABILITATION?
The lack of evidence of PV as a successful treatment for VCFs opens to questions on the role of rehabilitation. The frailty of these patients (high age, comorbidity, and chronic illness) entails a need of global care to contrast a general decline of health status and a consequent increased risk of mortality. The beneficial effects of multicomponent exercise programs have been suggested to reduce levels of pain and prevent falls in patients with osteoporosis.7 A collaborative program for all professionals involved in their care may help ameliorate the outcomes of PV in the long-term period, more than those obtained by single treatments.
The author thanks Cochrane Rehabilitation and Cochrane Musculoskeletal Group for reviewing the contents of the Cochrane Corner.
1. Buchbinder R, Johnston RV, Rischin KJ, et al: Percutaneous vertebroplasty for osteoporotic vertebral compression fracture. Cochrane Database Syst Rev
2. Amin S, Achenbach SJ, Atkinson EJ, et al: Trends in fracture incidence: a population-based study over 20 years. J Bone Miner Res
3. Lau E, Ong K, Kurtz S, et al: Mortality following the diagnosis of a vertebral compression fracture in the Medicare population. J Bone Joint Surg Am
4. Leake CB, Brinjikji W, Cloft HJ, et al: Trends of inpatient spine augmentation: 2001–2008. AJNR Am J Neuroradiol
5. Hide IG, Gangi A: Percutaneous vertebroplasty: history, technique and current perspectives. Clin Radiol
6. Buchbinder R, Golmohammadi K, Johnston RV, et al: Percutaneous vertebroplasty for osteoporotic vertebral compression fracture. Cochrane Database Syst Rev
7. Giangregorio LM, Papaioannou A, Macintyre NJ, et al: Too fit to fracture: exercise recommendations for individuals with osteoporosis or osteoporotic vertebral fracture. Osteoporos Int