Pathological sacral fractures, such as sacral insufficiency fractures, are common among certain subsets of the population. Sacral insufficiency fractures are typically diagnosed in a frail elderly patient who experiences pain preventing or limiting ambulation. The most common cause is osteoporosis. Many other conditions lead to weakening of the bones that predispose to these insufficiency fractures. The most common are people on chronic steroids, poor nutrition, radiation exposure, and in those with cancer.
This article is sponsored by Medtronic
The diagnosis is often delayed because of clinical unfamiliarity and the fact that most transverse or nondisplaced sacral fractures are not clearly identified on conventional X-rays. Specifically, they often require advanced imaging techniques such as CT or MR imaging (MRI is the gold standard for diagnosis) for accurate diagnosis and characterization.
The prevalence of vertebral compression fractures (VCFs) in the U.S. is around 800,000 cases annually. It is estimated that 1.8 percent of women over the age of 55 who present at a hospital with back pain have sacral insufficiency fractures.i The actual figure is likely higher, as many sacral insufficiency fractures go undiagnosed because they may not show up on routine sacral X-rays and aren’t always associated with a traumatic event. In fact, studies show more than two-thirds of the patients diagnosed with sacral fractures aren’t able to associate their pain with a traumatic event.ii As a result, physicians often prescribe conservative treatment for patients with sacral insufficiency fractures, including physical therapy and prolonged bed rest. Patients report 20-45-day inpatient stays at the hospital and chronic narcotic use associated with pain from untreated sacral insufficiency fractures, which are a significant drain on healthcare dollars and result in lost productivity. Patients who undergo bed rest are at increased risk of pulmonary embolism and DVT as well as further muscle atrophy and bone loss.
However, there is another treatment option: sacroplasty.
During a sacroplasty procedure, physicians use specialized instruments to place bone cement into the sacrum, stabilizing the fracture and providing pain relief (similar to fracture treatment of any weight bearing bones).
“Our goal is to invest in technologies which will provide more patients sustainable treatment options, achieve better diagnoses and apply the right therapy earlier in the continuum of care. We are driving more awareness with primary care physicians, emergency room personnel, specialists and consumers about this treatment for sacral insufficiency fractures,” says Jeff Cambra, General Manager of the Interventional Pain Therapies Business at Medtronic. “We present therapy awareness programs to physicians and at society meetings, highlighting the need to conduct routine sacral X-rays to ensure sacral insufficiency fractures aren’t missed as part of the diagnosis. We offer primary and advanced training for physicians to diagnose these patients, and to better understand the sacroplasty procedure.”
Early intervention is an important consideration for both hospital costs and patient outcomes. Sacroplasty can have a large economic impact on the healthcare system. Underdiagnosis may lead to long-term pain and disability. Inpatient length of stay could range from 20 to 45 days for sacral fracture patients in addition to disability from prolonged bed rest and narcotic use.i Sacroplasty, on the other hand, is typically a 20-minute procedure and patients may experience full pain relief.iv Allan Brook, MD,FSIR, an interventional neuroradiologist at Montefiore Medical Center, Bronx, N.Y.- reports sustained clinical and functional success with his patients.
“My outcomes are fantastic,” says Dr. Brook. “A patient in severe pain can have sacroplasty performed and overnight their pain is relieved. I’ve had secretaries with sacral insufficiency fractures come in, undergo the procedure and return to work the next day.” Stabilizing a fracture is important to allow the body to heal, just like a broken leg, so they can ambulate, and do their daily activities without pain.
A. Orlando Ortiz, MD, MBA, and Dr. Brook published an article in Techniques in Vascular and Interventional Radiology titled “Sacroplasty” describing the procedure and identifying outcomes in properly selected patients.
A recent multi-center retrospective study of 243 patients with osteoporotic SIFs treated with sacroplasty reported significant pain relief for patients immediately following the procedure and at one-year follow-up; the authors indicated that there were no major complications or procedure-related deaths. The study reported a low procedure-related complication rate with 1 of 243 subjects (0.4%) having symptomatic cement leakage requiring decompression.iii
Physicians perform sacroplasty under image guidance, either with CT or fluoroscopic technology.
“Visualization is critical to the success of the procedure. It is essential to employ high-quality fluoroscopy or CT equipment,” says Sam Lee, product development director at Medtronic. “The sacrum is a unique shape, so it’s also very important for physicians to perform the proper pre-operative planning steps to orient themselves to the anatomy of the fracture in this bone.”
Sacroplasty involves percutaneously inserting one or more bone needles into the sacrum and injecting bone cement to stabilize the fracture. Medtronic’s Kyphon Xpede™ Bone Cement is a polymethylmethacrylate (PMMA) bone cement formulation which rapidly reaches a doughy viscosity appropriate for injecting into bone, including indications for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty. There are risks to the procedure, including serious complications, including infection and leakage of bone cement into the muscle and tissue.
“In my practice, ideally, we augment the bone with cement and the patient then returns home the same day,” says Dr. Brook. “Among normal bone fractures, the physician will usually cast the bone and expect the bone to heal in six weeks. But when the patient has bad bones, the fracture doesn’t heal well and they’re left in pain. It’s harder to treat these patients conventionally, because you can’t stabilize the pelvis or put a cast on the spine. Instead, we do internal casting through the needle.”
The Kyphon™ Cement Delivery System is a hydraulic system for remote delivery of bone cement, featuring four feet of tubing to allow surgeons to stand outside of the fluoroscopic field, which has been shown to reduce radiation exposure to the hands by up to 70 percent*. The system also features a quick-release button to immediately relieve pressure and stop the flow of cement to minimize potential cement extravasation.
“Control is very important to physicians for the safety of the patient, and this device allows surgeons a high degree of control,” says Mr. Lee. “The quick-release button means if surgeons suspect a leak at any time they can hit that button and stop cement flow instantly.”
Clinical studies have shown rapid pain relief that was maintained up to a year after surgery. A study of 233 patients undergoing sacroplasty for sacral insufficiency fractures or sacral lesions reported significant and durable pain relief; 31 percent of the patients reported complete pain relief. The average cement volume used in the study was 4.1 mL, and no major complications were reported.iii
“Sacroplasty is essentially performing a vertebroplasty for the sacrum. Injecting bone cement has been shown to alleviate pain rapidly by stabilizing the micromotion of bone fragments rubbing together,” says Mr. Lee.
Patients with severe pain due to sacral insufficiency fractures are the best candidates for these procedures, extending to patients with primary or metastatic neoplasms of the sacrum. It is crucial to identify patients early and move forward with treatment.
“The sooner you can treat patients, the less deformed their bones become. When bones are partially healed, they are harder to treat, and the patients remain in severe pain,” says Dr. Brook. “The best candidates are known osteoporotic patients with a previous fracture and they fall again, or cancer patients without any other treatment options. The sooner they get treatment, the better the outcome will be, because the bone otherwise heals in a nonanatomic way.”
In the future, Medtronic plans to continue investment in the fracture management arena, in the spine as well as in other bones. “We want to drive innovation through the continuum of care with image-guided treatments,” says Mr. Cambra. “Our largest customer segment is interventional radiologists, and we want to continue developing image-guided and needle based, smaller percutaneous procedures for them while complementing our portfolio with products aimed at minimally invasive spine surgery.”
Payer coverage for sacroplasty may vary. Medtronic recommends providers review all payer coverage policies and/or call payers to determine coverage criteria and appropriate coding. Risks of acrylic bone cements include cement leakage, which may cause tissue damage, nerve or circulatory problems, and other serious adverse events, such as: cardiac arrest, cerebrovascular accident, myocardial infarction, pulmonary embolism and cardiac embolism.
*The mean radiation reduction at the hands was 77.8% (p <0.001). Based on internal testing of 24 cadaveric procedures (n = 12 using Kyphon™ CDS; n = 12 using Kyphon™ Bone Filler Device). Dosimeters were placed on the wrist and fingers to measure radiation when delivering bone cement into the vertebral body. Radiation results are based on adherence to the Directions for Use.
A prescription is required. This therapy is not for everyone. Please talk to your doctor about the risks and benefits of this procedure and to decide whether this procedure is right for you. Results may vary. For more information, please call Medtronic at 1-763-505-5000 and/or consult Medtronic’s website at www.medtronic.com.
Disclaimer: Dr Allan Brook is a consultant for Medtronic and has received compensation from Medtronic for participating in this segment.
References:
i. Ortiz AO, Brook AL. Sacroplasty. Tech Vasc Interv Radiol. 2009: 12(1); 51-63. doi: 10.1053.
ii. Wagner D, Ossendorf C, Gruszka D, Hofmann A, Rommens PM. Fragility fractures of the sacrum: how to identify and when to treat surgicall? Eur J Trauma Emerg. Surg. 2015; 41(4): 349-362. doi: 10.1007/s00068-015-0530-z.
iii. Frey M, DePalma M, Cifu D, et al. Percutaneous sacroplasty for osteoporotic sacral insufficiency fractures: a prospective, multicenter observational pilot study. Spine J. 2008; 8(2): 367-373.
iv. Kortman K, et al. Multicenter study to assess the efficacy and safety of sacroplasty in patients with osteoporotic sacral insufficiency fractures or pathologic sacral lesions. J Neurointerv Surg. 2013 Sep 1;5(5):461-6.
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