Findings Support Vertebral Augmentation Over Non-surgical Management of Vertebral Compression Fracture

Peer Reviewed

Strong support for vertebral augmentation over non-surgical management of vertebral compression fractures was found in a recent meta-analysis of 25 prospective studies. Balloon kyphoplasty was linked to significantly greater pain reduction over non-surgical management and significant improvements in pain reduction and disability score as compared with vertebral augmentation with implant, researchers reported in the July issue of the International Journal of Spine Surgery.

The findings “will help foster the evidence-based approach to establish the utility of vertebral augmentation, including vertebroplasty, kyphoplasty, and vertebral augmentation with implants,” said lead author Douglas P. Beall, MD, Chief of Operations, The Spine Fracture Institute, LLC, Oklahoma City, OK. “As the validity of a technology cannot be reliably based on the result of a single study, this meta-analysis highlights the advantages of vertebral augmentation over non-surgical management in every category, many of which were significantly better.”

“Balloon kyphoplasty had significantly better pain reduction as compared with non-surgical management,” Dr. Beall said. “Vertebroplasty also tended to improve pain reduction as compared with non-surgical treatment. As expected, there was also better height restoration of the vertebral body with kyphoplasty as compared with vertebroplasty.”
Post-procedural image of multi-level vertebral augmentation using vertebroplasty.Post-procedural images (not related to this study) of multi-level vertebral augmentation using vertebroplasty.Meta-analysis Design
The 25 prospective studies included in this meta-analysis were all Level I or II and compared vertebral augmentation versus non-surgical management for mid-/lower-thoracic and lumbar vertebral compression fractures. Each study included at least 20 patients, and was published between February 1, 2011 and November 22, 2016. None of the patients had traumatic non-osteoporotic or cancer-related fractures.

As shown in the Table, balloon kyphoplasty was associated with statistically superior pain reduction compared with non-surgical management. While pain reduction was greater with vertebroplasty compared with non-surgical management, this difference was not statistically significant.

When comparing kyphoplasty modalities, balloon kyphoplasty was linked to significantly greater pain reduction and disability improvement compared with vertebral augmentation with implant, and a non-significant trend toward greater anterior and posterior vertebral height restoration than vertebroplasty.
Table. Kyphoplasty Versus Non-surgical Management of Vertebral Compression Fractures.Table. Kyphoplasty Versus Non-surgical Management of Vertebral Compression Fractures.Data Confirm Previous Meta-Analyses Findings
“The results of the meta-analysis can be compared to other meta-analyses such as from Rzewuska et al, who analyzed five studies and found low quality of evidence on the benefits of opioids, non-steroidal anti-inflammatory medications, and spine bracing, and concluded that there is insufficient data to recommend optimal conservative management for the treatment of osteoporotic vertebral fractures,” Dr. Beall told SpineUniverse.1 “Based on the comparison of the findings between the meta-analyses, non-surgical management should be employed less often and guidelines should favor vertebral augmentation for the treatment of osteoporotic vertebral fractures much more often.”

Dr. Beall also noted similarities between his findings and previous meta-analyses by Papanastassiou et al and Anderson et al.2,3 However, his study “provides strong support for vertebral augmentation especially relative to non-surgical management and uses the most recent data to establish a pattern of safety and efficacy of vertebral augmentation in the treatment of vertebral compression fractures,” Dr. Beall said. “This meta-analysis also introduces readers, for the first time in this format, to vertebral augmentation with implants that have the potential to expand and improve the treatment of vertebral compression fractures.”

Commentary

Saad B. Chaudhary, MD, MBA
Minimally Invasive & Complex Spine Surgery
The Mount Sinai Hospital
Associate Director, Spine Surgery Fellowship
Assistant Professor
Icahn School of Medicine at Mount Sinai
Department of Orthopaedic Surgery

After the publication of the two New England Journal of Medicine articles by Buchbinder and Kallmes,1,2 balloon kyphoplasty and vertebroplasty procedures were considered ineffective by some. In fact, in 2011 the American Academy of Orthopaedic Surgeons (AAOS) published guidelines that recommended against cement augmentation.3 Since that time, however, several new high-level prospective studies have been done, which do show significant improvement in pain and function after cement augmentation for acute compression fractures. This meta-analysis re-affirms the aforementioned findings and hopefully this data can facilitate a reversal of the recommendations against vertebral augmentation for the appropriate patients.

While scrutiny is healthy when it comes to adopting medical treatments, biased data and methodological flaws must be critically evaluated, addressed, and updated when making medical recommendations or guidelines. The data in this meta-analysis along with several other recent prospective randomized controlled trials show a significant improvement in pain relief and functional recovery in the cement augmentation patient population vs. the non-operative patients for acute compression fractures. Therefore, the medical and surgical societies would need to consider revising some existing guidelines for the benefit of patients with this common and painful condition.

Osteoporosis is a very common disease state and resultant vertebral compression fractures will be diagnosed with more frequency in our aging population. Most clinicians agree that the first line treatment for these fractures is conservative medical management and systemic treatment and prevention of osteoporosis whenever possible. However, when patients fail six to eight weeks of conservative care and continue to have debilitating pain, cement augmentation either with a balloon kyphoplasty or vertebroplasty is an efficacious and minimally invasive treatment option. This current publication pools data from 25 relevant studies and underscores the effectiveness of this procedure.

References:
1. Buchbinder R, Osborne RH, Ebeling PR, et al. A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med. 2009;361(6):557-568.

2. Kallmes DF, Comstock BA, Heagerty PJ, et al. A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med. 2009;361(6):569-579.

3. Esses SI, McGuire R, Jenkins J, et al. American Academy of Orthopaedic Surgeons clinical practice guideline on: the treatment of osteoporotic spinal compression fractures. J Bone Joint Surg Am. 2011;93(20):1934-1936.

Disclosures
Click here for Dr. Beall’s disclosure information.
Dr. Chaudhary has no relevant disclosures.

Updated on: 08/30/18
Continue Reading
Vertebroplasty Reduces Acute Pain Following Osteoporotic Vertebral Fractures in VAPOUR Study
Douglas P. Beall, MD
Chief of Operations
The Spine Fracture Institute
Chief of Radiology Services
Clinical Radiology of Oklahoma
Saad B. Chaudhary, MD, MBA
Minimally Invasive & Complex Spine Surgery
The Mount Sinai Hospital
Associate Director, Spine Surgery Fellowship
Assistant Professor
Icahn School of Medicine at Mount Sinai
Department of Orthopaedic Surgery
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