Surgeons remain divided on how to treat vertebral compression fractures

Vertebral compression fractures are most commonly caused by osteoporosis, but these injuries can also result from trauma to the back or from tumors that develop in the spine or spread to the spine from elsewhere in the body.

Vertebroplasty or kyphoplasty procedures to treat a vertebral compression fracture (VCF) involve a cement solution injected into the space of a collapsed vertebrae to stabilize the injury and in some instances restore vertebral height. They are often used when the surgeon believes a surgical route is the best solution for the patient, and opinions about the effectiveness of both procedures vary.

Hyun Bae, MD, medical director at Cedars Spine Center and research director at The Spine Center in Santa Monica, Calif., told Spine Surgery Today, if a patient comes into his office in considerable pain after 4 weeks to 8 weeks of conservative treatment, then it is time to treat the injury in an aggressive manner.

“Getting the patient’s functional status restored is the besttreatment,” Bae said.

Since most patients with a VCF are elderly, he said, keeping them ambulatory is the best approach to care. If they are still in significant pain after conservative treatment, such as bracing or medication, he starts considering either vertebroplasty or kyphoplasty as an option.

In a patient who is cancer-free and the compression fracture is not due to a tumor or myelopathy, many surgeons take a conservative route first to see if a patient responds to that type of treatment, Alexander R. Vaccaro, MD, PhD, president of the Rothman Institute and chairman of the Department of Orthopaedic Surgery at Sidney Kimmel Medical College at Thomas Jefferson University, in Philadelphia, told Spine Surgery Today.

“You need to find out how they developed their vertebral compression fracture, first. Was it a simple fall, osteoporosis? Then you get the patient in tune with a medical physician to get a DEXA scan, a full metabolic workup, and get them on the appropriate medication,” he said.

Initially, Vaccaro puts patients with a VCF in a comfortable brace to see if it makes them feel better and then gives them medication to make them feel better. He will then rule out if it is an infiltrative lesion, such as cancer.

“That happens very rarely, but that is in the initial workup,” Vaccaro said, noting this kind of conservative approach can often save a patient from undergoing one of the surgical options.

Initial workup is required

The initial workup of a patient with a VCF is key to determining the best treatment course, according to Heidi Prather, MD, a physiatrist and director of the Chesterfield Orthopedic Spine Center at Washington University School of Medicine, in St. Louis. She told Spine Surgery Today she agreed with Vaccaro’s assessment that MRI or radiographs should be taken of a patient presenting with this type of injury to confirm the compression fracture, to see how old the injury is and if it is an acute fracture.

“If the patient only has axial back pain, no leg pain, no pain other than the spine, I will start with conservative treatment. We work first on pain relieving things, like bracing, which can help provide proprioceptive feedback to muscles that work to stabilize the spine and limit lumbar flexion, a pain provocative position for patients with acute and sub-acute compression fractures. Medications and ice in the acute setting can help pain related to bony fracture and soft tissue inflammation,” Prather said.

She said she then starts the patients on a therapeutic exercise intervention that moves toward improving posture, maintaining strength, and building strength if they maybe lost it prior to the fracture.

Prather stressed that situations where physicians have to push patients into vertebral augmentation procedures without first trying conservative treatment should be avoided.

Surgery not always necessary

According to Prather, the procedures performed for VCFs today are safe and offer good results, but they are invasive. Furthermore, they can be costly for patients and additional fractures after vertebral augmentation also need to be managed.

“Not everyone with a compression fracture needs augmentation. We still see that in my community, at times, where a person presents to an ER with first onset of back pain with a newly identified compression fracture, and they are offered augmentation immediately. It is expensive. A study from 2006 conducted at our university of patients with non-pathological vertebral compression fractures with 8 weeks or more of pain and continued edema in the vertebral body on MRI treated with vertebroplasty found that 30% of people had another fracture at another site within the first 3 months of treatment,” she said.

However, some physicians find it difficult to not offer vertebral augmentation to patients who present in the emergency room with pain, but not offering patients a conservative form of treatment can deny patients a more natural way of healing, she said.

Conservative treatment and physical rehabilitation should be offered as a first resort for 8 weeks to patients who have an uncomplicated compression fracture, Prather said.

In the right patient this avoids the complications that occur above and below the treated level or changes that occur due to the procedure, she said. But if after that time the patient still presents with pain, then vertebral augmentation may be needed.

“You need to treat the patient, not the fracture,” Prather said.

Aggressive care is best

Not everyone believes conservative treatment is the necessary first step or that it is effective in the treatment of most VCFs.

Douglas P. Beall, MD, of Clinical Radiology of Oklahoma, in Edmond, Okla., told Spine Surgery Today if a patient with a VCF presents to him with a pain score of 7 points out of a possible 10 points, conservative treatment will likely not work and will be a waste of time.

“If you have moderate to severe pain or more, I do not start with non-surgical management. The primary indicators are that people do not get better with that. If people do start with moderate to low pain, then maybe [I will prescribe] conservative management provided they can tolerate conservative management because its relative rate of mortality is between 8 times and 9 times more than somatic control,” Beall said.

He cited a 2008 study by Suzuki and colleagues that showed patients with severe VCF pain who were treated conservatively still have severe pain at 1-year follow-up, and 76% of patients still had pain that was regarded as severe in the study. Only 10% reported no or very little pain, Beall said.

“We fail tremendously at treating patients with fractures. We put a brace on them, do non-surgical management, and there is incredibly little evidence about this,” he said. “We argue there is very little level 1 evidence about vertebral augmentation, but the last time I checked there were 27 level 1 and level 2 articles about vertebral augmentation. There is only one level 1 article I know of about bracing.”

Which surgery is best?

If surgery is indicated, Vaccaro said kyphoplasty and vertebroplasty are both effective and have been found to greatly reduce pain when compared with non-surgical management in patients with osteoporotic VCFs.

He discussed a 2012 study in EuroSpine Journal in which by Papanastassiou and colleagues compared the two procedures with non-surgical management.

“[Papanastassiou] reviewed 27 studies, and he noted the pain reduction in kyphoplasty and vertebroplasty was superior to nonsurgical treatment, with a P value of less than 0.01,” Vaccaro said. “He could not find a difference between kyphoplasty and vertebroplasty for pain, but he found subsequent fractures were more common in non-surgical groups. He also found quality of life improvement favored kyphoplasty over vertebroplasty.”

Individualize the approach

Bae said to determine which surgical procedure he will use he typically considers whether void creation is necessary. For a fracture with suspected malignancy, creating a void may be beneficial in order to better guide cement placement. In a typical osteoporotic fracture, Bae will typically favor vertebroplasty over kyphoplasty, due to simplicity and more uniform cement dispersion.

“The only time I will consider using kyphoplasty is truly in the acute setting, when I really feel I can get some type of height correction. Even when that happens, I do not think the height correction impacts the overall results significantly,” he said. “There are some indications when I will absolutely use a balloon, such as a fracture which may have a heterogenerous nature, meaning that vertebra may not only contain bone but a tumor mass,” Bae said.

Kyphoplasty for cancer cases

If Bae suspects the fracture resulted from metastatic disease, he typically prefers performing kyphoplasty, mostly because he is unsure of what is inside the space of the compression fracture. A soft tissue mass could be present in the space, he said, and that would make the control of cement at injection much more difficult.

With an empty space you can usually tell where the cement will go and how it will set, according to Bae, but if you have a soft tissue mass then the cement placement and fluidity cannot be predicted.

It is also difficult to control cement distribution when it is injected into a soft tissue mass, Bae said.

“It is like injecting cement into an orange. If you inject it into an orange, you have no idea where it will seep out. If you inject into a sponge, you know that it will be somewhat contained around the injection site,” he said. “So, in those cases I think it is a lot safer to create a void first and inject cement; not for height restoration, but to create a void for controlled cement placement.”

Not mutually exclusive

The two methods of surgical treatment for VCFs are not mutually exclusive, Isador H. Lieberman, MD, MBA, FRCSC, of the Texas Back Institute, told Spine Surgery Today. They each have their negatives and positives and should therefore be tailored to a patient’s needs, he said.

“Vertebroplasty and kyphoplasty are not mutually exclusive. They represent treatment options in the spectrum,” Lieberman said. “If you simply need stabilization, than a vertebroplasty technique is used, and if you need a reconstruction, then a kyphoplasty technique is used.”

Prather, who does not perform either of these augmentation procedures, disagreed, saying both of the techniques seem to offer the same results in the literature she has read on the subject. The evidence is very mixed and there is no consensus as to which procedure has a better health outcome than the other, she said.

Training may best direct treatment

However, Prather manages the care of patients treated with both procedures at her hospital and has seen the results. Knowing the literature is mixed, it makes the most sense that a physician does the procedure for which he or she is best trained because the biggest concern for patients is that the procedure is technically done well and they attain a good health outcome, she said.

“If someone is highly trained in kyphoplasty and that is what is available for you, I do not think asking for vertebroplasty would be a wise thing, and vice versa,” Prather said. “At our university, surgeons will often, in unique cases, use kyphoplasty in an area around a tumor that they have got to fuse above and below, for stability. There are some unique and great reasons to use it in those settings. Then it is a game changer,” she said. “But, I think for the average person with just a vertebral compression fracture with no other outliers or comorbidities directly related to that fracture, I think it is probably best to go with what the expertise is of the person performing the procedure. If you have the choice of two and they are equal, then cost may drive where the patient goes, as well.”

Kyphoplasty outcomes

Beall told Spine Surgery Today that vertebroplasty should no longer be the jumping off point for vertebral augmentation that it was in the past. Recent studies have shown kyphoplasty provides better health outcomes for patients than vertebroplasty and better pain reduction.

“I do not do vertebroplasty as a first line anymore and we should not be doing it as a first line anymore. The RAND [RAND/UCLA Appropriateness Method] criteria said we should only use it about 6% of the time. Vertebroplasty is less optimal than kyphoplasty because it has less pain relief; it has 4.55 points of pain reduction as opposed to 5.07 points for kyphoplasty,” Beall said. “[The criteria] also said kyphoplasty provides a better quality of life. Now that we have mortality data from several papers, kyphoplasty provides mortality reduction statistically significantly more than vertebroplasty. It is my strong position that we should not be doing vertebroplasty in the first line anymore.”

Different cements used

In addition to the various procedures to treat a VCF, another factor is the type of cement slurry used in the procedures. No one type of cement is used in every vertebroplasty or kyphoplasty procedure, Vaccaro said, and a number of different factors come into play based on the material that is selected.

If cost is not considered at all by a hospital or surgeon when doing the VCF repair procedure, Vaccaro said he would prefer to use acrylic cement.

“Acrylic cements: the pros are good mechanical properties, a simple mix and delivery, and they are euthermic, which means you are not going to burn the surrounding tissues,” Vaccaro said. “They do have downsides though, such as monomer toxicity. They have not been around too long and some companies say they are osteoconductive. However, that is up to question.”

Cements used for treating VCFs have made advances during the past few years, according to Bae. Cements are now more viscous or thicker and have more consistent polymerization or set times. Cements used in the past were watery or less viscous and more difficult to control than the thicker cements of today, he said.

“If you are just talking about methylmethacrylate cement, every major vertebroplasty company now has high viscosity cement with a consistent prolonged polymerization phase. The cements which can achieve high viscosity rapidly after they are mixed and can hold that viscosity for long periods before complete polymerization, those are the cements I like best,” Bae said.

The runny cements used for vertebroplasty cases are associated with increased leakage outside the vertebral body and inconsistent set times,” he said. “Basically we now have cements that are very thick and they stay thick for a long time. This allows for increased working time with safer and more dependable delivery of cement,” he said. – by Robert Linnehan

References:

Klazen CA. Lancet. 2010;doi:10.1016/S0140-6736(10)60954-3.
Papanastassiou ID. Eur Spine J. 2012;doi:10.1007/s00586-012-2314-z.
Prather H. J Bone Joint Surg Am. 2006;88:334-341.
Suzuki N. Eur Spine J. 2008;doi:10.1007/s00586-008-0753-3.

 

Safe and effective

My answer is yes from my personal experience, which started in 1997 for vertebroplasty and in 1998 for kyphoplasty. With more than 6,000 cases (approximately 50% of them vertebroplasty), I have found rapid relief in a matter of a few hours at the conclusion of the procedure for both osteoporotic and malignant vertebral compression fractures. I have found this is hardly ever the case for conservative management in which patients remain miserable for weeks to often months after fracture onset. Most of the literature supports a success rate of 80% to 90% significant pain reduction.

Vertebroplasty and kyphoplasty are extremely safe procedures with almost negligible complications if performed properly with complication rates of less than 2% for osteoporotic fractures and less than 5% for malignant vertebral compression fractures.

I tend to favor kyphoplasty for recent fractures less than 4 weeks old, difficult anatomy such as vertebra plana, retropulsion in a stable fracture, some malignant processes and other situations where there is a potential for cement leakage. However, positive results are encountered with both forms of vertebral augmentation.

Wade Wong, DO, FACR, FAOCR, is a professor emeritus of Radiology and chief of Spinal Interventional Radiology at UC San Diego School of Medicine.

Disclosure: Wong previously served on the speaker’s bureau for Kyphon Medtronic, Stryker, ArthroCare, Smith & Nephew and CareFusion.

References:
Mathis JM. Am J Neuroradiol. 2001;doi:22:1212–1216.
Theodorou DJ. J Clin Imaging. 2002;doi:26:1-5
Wong W. J Wom Imag. 2000;2:117-124.

 

Balloon kyphoplasty provides fast, effective relief

Vertebral augmentation methods include vertebroplasty, balloon kyphoplasty ([BKP], considered the gold standard during the last 10 years) and now Kiva, a new, implant-based approach.

The Fracture REduction Evaluation Study (FREE) showed that BKP resulted in more rapid improvement in back pain relief compared to conservative care in treating acute vertebral compression fractures (VCFs). Patients also experienced more rapid improvement in quality of life, back function and mobility than with non-surgical care. The FREE study was a 300-patient, multicenter, randomized controlled trial and 1-year results were published in The Lancet. Another study by Edidin published in the Journal of Bone and Mineral Research showed significantly higher survival rates among patients treated with BKP vs. patients treated with either vertebroplasty or non-surgical care.

Kiva is a new option to treat VCFs that was not available when the FREE and Edidin studies were published. In three separate studies, Kiva was shown to be equivalent to BKP in safety, reducing pain and restoring function. An independent study published in Pain Physician Journal showed that using Kiva resulted in statistically significant advantages over BKP in addressing pain, as well as in improving longer term results by reducing future fractures.

In my opinion, significant clinical evidence demonstrates that vertebral augmentation, particularly BKP, provides greater and faster pain relief and improved function than conservative care and should be considered earlier than at 6 weeks. Now Kiva presents us with a new option for vertebral augmentation that, based on initial research, appears to demonstrate advantages over BKP.

Wayne Olan, MD, is the director of Minimally Invasive and Endovascular Neurosurgery at GW Hospital and an Associate Professor of Neurosurgery and Radiology,  in Bethesda, Md.

Disclosure: Olan is a consultant for Benvenue Medical and is on the speaker’s bureau for Benvenue Medical and Stryker.

References:
Edidin AA. J Bone Miner Res. 2011;doi:10.1002/jbmr.353.
Korovessis P. Spine. 2013;doi:10.1097/BRS.0b013e31826b3aef.
Otten LA. Pain Physician. 2013;doi:16:E505-E512.
Tutton SM. J Vasc Interv Radio. 2014;doi:http://dx.doi.org/10.1016/j.jvir.2013.12.307.
Wardlaw D. Lancet. 2009;doi:10.1016/50140-6736(09)60010-6.