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Percutaneous Vertebroplasty 2016-10-24T14:00:00+00:00
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Percutaneous Vertebroplasty

An Effective Intervention for the Treatment of Vertebral Compression Fractures

Paul J. Lynch, MD, DABA
Assistant Professor of Anesthesiology
Mayo Clinic College of Medicine, Rochester, Minnesota
Consultant, Anesthesiology and Pain Management
Mayo Clinic Scottsdale/Phoenix, Arizona
Founder, Arizona Pain Specialists, Scottsdale, Arizona

Nicole E. Berardoni, MD
Director of Research
Arizona Pain Specialists
Scottsdale, Arizona
www.ArizonaPain.com

Vertabra-Fracture Vertebral compression fractures (VCFs) are a major health concern today, with an estimated 700,000 osteoporosis-related VCFs occurring annually; the result is 150,000 hospitalizations. To put it in perspective, a VCF occurs every 45 seconds. The number of VCFs has reached epidemic proportions, particularly among elderly white women. After the first fracture, the risk for subsequent fractures increases five-fold. The lifetime risk for a VCF is 16% in women and 5% in men.

Causes and Symptoms

VCFs can be suspected at the time of clinical presentation and diagnosed by radiography (Figure 1). VCFs most frequently occur when the combined axial and bending stress on the spine exceeds the strength of the vertebral body (Figure 2).

Osteoporosis, the most common condition related to VCFs, affects ten million people—including 45% of white women older than 50 years of age—according to the National Osteoporosis Foundation (Figure 3). Osteoporotic VCFs often remain stable and asymptomatic; however, in many patients, symptoms such as severe pain with limited mobility and function will develop acutely. A patient with a VCF classically presents with pain near the fractured level; sometimes vertebral collapse causes a loss of height, known as kyphotic deformity. However, pain may be the only symptom if the fracture is acute.

At first glance, VCFs seem to be a benign condition that is a normal part of aging. The data are clear, however, that VCFs cause significant morbidity and mortality that can be avoided with proper early intervention. Untreated VCFs can lead to chronic pain and kyphotic deformity, thus causing depression, decreased pulmonary function, impaired mobility, increased risk for deep vein thrombosis, and an overall reduction in the quality of life. Indeed, the mortality rate in patients with VCFs is 23% to 34% higher than that of patients with no fracture.

Currently, osteoporotic compression fractures cost more than $13.8 billion in direct expenditures, with a projected cost in 2030 of more than $60 billion, according to the National Osteoporosis Foundation.Vertebro Fracture, Broken back, Compression Fracture

Diagnosis and Treatment

The primary care physician plays a crucial role in the diagnosis and treatment of VCFs. All patients older than 50 who present with pain of acute onset in the middle or lower back should be evaluated for VCF. The pain is often relieved by lying down and exacerbated by activity. A thorough physical examination may find tenderness over the vertebrae (the pain can be inflicted by applying direct pressure over the corresponding spinous process). Kyphosis can also be seen. Other manifestations suggestive of nerve involvement include changes in bowel or bladder habits, the loss of lower extremity reflexes, and sensory changes.

Radiologic imaging should be ordered early if there is any suspicion of a VCF. This is a new teaching tool acquired within the last ten years and requires many primary care physicians to change their thinking about treatment algorithms for suspected fractures. Ten years ago, it was useless to order plain films or magnetic resonance imaging (MRI) for suspected fractures because no viable treatment option was available. Now, early imaging and diagnosis are necessary to reduce the morbidity and mortality associated with VCF.

Obtaining a plain X-ray film can assist in the diagnosis because the classic wedge-shaped vertebral body with anterior narrowing is seen in most patients with a compression fracture. However, in most cases, MRI, computed tomography, or a bone scan will be necessary. MRI with short tau inversion recovery (STIR) images or T2-weighted fat-suppressed images is quickly becoming the gold standard for diagnosing VCF, especially if a vertebroplasty is planned. If malignant metastases are suspected based on lesions seen with radiography, a complete malignancy workup should also be done at the same time.

After diagnosing a VCF, the primary care physician may choose to manage the patient medically or refer the patient to a specialist for an evaluation of further treatment options. The medical management of symptoms, including bed rest, analgesics, and physical therapy and rehabilitation, is currently the mainstay of therapy for VCF. However, 33% of patients managed medically have persistent pain and other symptoms requiring further treatment. Additionally, medical management does not include treating or preventing the development of kyphotic deformity.

Certain medications (e.g. non-steroidal anti-inflammatory drugs) are not well-tolerated by elderly persons, the population most often afflicted with VCFs. Similarly, the elderly are typically not good candidates for surgical decompression and stabilization of the vertebrae; thus, surgical fixation of the fractures is not an option. Furthermore, because of the fragility of osteoporotic bone, surgical fixation often fails. The combination of these factors has moved the standard of care toward early intervention with percutaneous vertebroplasty.

The evidence is good that diagnosing and treating osteoporosis reduces the incidence of compression fractures of the spine. Consistent exercise and other activities that strengthen muscles and improve flexibility help to decrease the incidence of vertebral fractures and the back pain associated with osteoporosis. Certain medications are prescribed for reducing the effects of osteoporosis—most commonly bisphosphonates, selective estrogen receptor modulators, calcitonin, parathyroid hormone, calcium, and vitamin D supplements.

Healthy BonesHealthy Bone
Osteoporotic BoneOsteoporotic Bone

Osteoporotic vertebral compression fractures often remain stable and asymptomatic; however, many patients will acutely develop symptoms such as severe pain with limited mobility and function. VCF classically present with pain near the fractured level and can sometimes produce a loss of height caused by vertebral collapse, known as kyphotic deformity. However, pain may be the only symptoms on presentation if the fracture is acute.

Though at first glance VCF seem to be a benign condition that is a normal part of aging, the data is clear that VCF cause a significant amount of morbidity and mortality that is avoidable with proper early intervention.  Untreated VCF can lead to chronic pain and kyphotic deformity, thus causing depression, decreased pulmonary function, impaired mobility, increased risk of deep vein thrombosis, and an overall reduction in the quality of life. Indeed, patients with VCF have a 23-34% increased mortality rate compared to patients without a fracture.

Currently osteoporotic compression fractures cost greater than 13.8 billion dollars in direct expenditures; with a projected cost in 2030 of greater than $60 billion, according to the National Osteoporosis Foundation.

What Factors go into the Diagnosis of this Condition?

The primary care physician plays a very crucial role in the diagnosis and treatment of a vertebral compression fracture. All patients over the age of 50 who present with the acute onset of mid- or lower-back pain should be evaluated for VCF. The pain is often relieved by lying down and is exacerbated with activity.

A thorough physical exam may show tenderness over the vertebrae (the pain can be inflicted with direct pressure over the corresponding spinous process).  Kyphosis can be seen as well. Other manifestations suggestive of nerve involvement include changes in bowel or bladder habits, loss of lower extremity reflexes, and sensory changes.

Radiological imaging should be ordered early if there is any suspicion of VCF.  This is a new teaching tool just over the last ten years and requires many primary care physicians to change their thinking on treatment algorithms for suspected fractures.  Ten years ago it was useless to order plain films or MRI for suspected fractures, because there was no viable treatment option available.  Now early imaging and diagnosis is necessary to reduce morbidity and mortality associated with VCF.  Plain film X-ray may be diagnostic because it is commonly seen in the classic wedge-shaped vertebral body with narrowing of the anterior portion in most compression fractures. However, in most cases a MRI, CT, or a bone scan will be necessary.  MRI with STIR images or T2 fat suppressed images is quickly becoming the gold standard for diagnosing VCF, especially if a vertebroplasty is being planned.  If malignant metastasis are suspected due to lesions seen on radiograph then a complete malignancy work-up should be done at this time as well.

Once the diagnosis of a VCF has been established, the PCP may choose to medically manage the patient themselves or they may then refer the patient to a specialist to be evaluated for further treatment options. The current mainstay of therapy for VCF is medical management for symptomatic VCF; including bed rest, analgesics, and physical therapy or rehabilitation. However, 33% of patients who receive medical management have persistent pain and symptoms requiring further treatment.  Additionally, medical management does not treat or prevent the development of kyphotic deformity. Certain medications (NSAIDs) are not tolerated well by the elderly, who are afflicted the most with VCF. Similarly, the elderly are typically not good surgical candidates for decompression and stabilization of the vertebrae so surgical fixation of the fracture is not an option.  Furthermore, the fragility of the osteoporotic bone often causes failure of surgical fixation.  All of these factors have combined to move towards early intervention with percutaneous vertebroplasty as standard of care.

There is good evidence that diagnosing and treating osteoporosis reduces the incidence of compression fractures of the spine. Consistent exercise and activity to help with muscle strengthening and flexibility should also be done to help decrease vertebral fractures and back pain associated with osteoporosis.  Certain medications are used to attempt to reduce the effects of osteoporosis.  The most commonly prescribed medications are biosphosphonates, selective estrogen receptor modulators, calcitonin, parathyroid hormone, and calcium and vitamin D supplements.

What Are the Options for Treatment?

Vertebroplasty and balloon-assisted kyphoplasty are two innovative, minimally-invasive, non-surgical procedures that have proven to strengthen the vertebrae of the spine and significantly improve pain caused by VCF through a percutaneous injection of bone cement into the vertebral body.  Vertebroplasty and kyphoplasty are considered when pain does not resolve with conservative treatment.  Vertebroplasty, unlike kyphoplasty, can be performed on an outpatient basis, is significantly less expensive, and does not require general anesthesia or hospital admission. Vertebroplasty is also used as an adjuvant therapy for preoperative, perioperative, and intraoperative percutaneous stabilization for spinal decompression procedures.

Vertebroplasty was originally performed in 1984 by Deramond in Amiens, France using a trans-oral approach.  It was then introduced into the US in 1993. Balloon kyphoplasty was first reported in 1998 to help restore vertebral body height using an inflatable balloon to reduce the fracture before injecting cement into the vertebral body. Vertebroplasty was developed purely as a pain treatment, whereas kyphoplasty was developed to restore vertebral body height.  However, certain studies have shown that following a kyphoplasty the patient is pain-free, so they are able to stand up straighter so it would appear the vertebral height was corrected more than it actually was.

Since their introduction they have both widely gained acceptance and are indicated for the treatment of pain associated with:

  1. Painful primary and secondary osteoporotic VCF refractory to medical therapy (minimal or no pain relief with the administration of prescribed analgesics or adequate pain relief with narcotic dosages that produce undesirable effects).
  2. Painful vertebrae with extensive osteolysis or invasion of the vertebral body secondary to benign or malignant tumor.
  3. Painful vertebral fracture associated with osteonecrosis.

No present data supports the use of vertebroplasty for prophylaxis for the prevention of VCF.

Contraindications for the use of vertebroplasty include:

Absolute:

  1. Asymptomatic vertebral body compression fractures
  2. Infection (local or systemic)
  3. Retropulsed bone fragment resulting in myelopathy
  4. Spinal canal compromise secondary to tumor resulting in myelopathy
  5. Uncorrectable coagulopathy
  6. Allergy to bone cement or opacification agent

Relative:

  1. Radiculopathy in excess of vertebral pain, caused by a compressive syndrome unrelated to vertebral collapse
  2. Asymptomatic retropulsion of a fracture fragment causing significant spinal canal compromise
  3. Asymptomatic tumor extension into the epidural space

For billing purposes, there are only three accepted indications for vertebroplasty:

  • Osteolytic fracture due to benign or malignant disease
  • Osteonecrosis
  • Osteoporotic fracture

What Is Vertebroplasty and How Does it Help?

Vertebroplasty Advancment

After an IV is started, the patient is placed in the prone position on the fluoroscopy table and draped and prepped in a sterile fashion exposing the thoracic or lumbar area. Moderate conscious sedation is given and a 25-gauge needle is used to anesthetize the skin, subcutaneous tissue, and pedicle of the affected vertebral segment.  A 3.5 inch spinal needle is often used to anesthetize a track from the skin to the pedicle. Close attention to local anesthesia at this stage allows this procedure to be done with minimal sedation.

The C-arm is rotated and positioned until the pedicles of the affected vertebrae are easily identified. Fluoroscopy is preferred over computed tomography (CT) because it allows a multiplanar view with real-time visualization for cannula insertion and cement injection. It also permits rapid rotation between PA and lateral views without complex equipment moves or projection realignment.

Several approaches have been used to advance the needles: anterolateral (cervical only), poster lateral (lumbar only), parapedicular, and transpedicular, with transpedicular being the most commonly used. Osteoporotic fractures rarely occur in cervical spine, but when a fracture does occur there, the anterolateral approach is used because a transpedicular route is very difficult. However, to avoid the carotid-jugular complex, as in cervical discography, the physician can manually push the carotid artery out of the path of the needle.

For the majority of the cases, the fractures are due to osteoporotic bone, so advancing the needle into the vertebral body should be very easy. However, if the bone is affected by a neoplastic tumor it may be very strong and dense, thus requiring the use of the mallet to help advance the needle. The tip of the needle should be positioned beyond the middle of the vertebral body (seen on lateral projection).

Once the needle is placed, a second needle is positioned identically through the contralateral pedicle of the same vertebrae. The use of the second needle is the bi-pedicular approach, where two needles are placed, one entering on each side of the vertebral body. The two needle placement decreases the risk of cement leakage, which is commonly seen when only one needle is used.  This can then be performed in an identical fashion at other levels that are to be treated in the case of multi-level fractures.  Once the needles are placed in the correct location, the cement is mixed. PMMA (polymethyl methacrylate) is the only cement approved by the U.S. Food and Drug Administration as a device for the use in the treatment of pathologic fractures in the spine. The cement mixture can be altered by the application of an opacification agent or antibiotics; however, the reformulation will no longer be U.S. FDA approved.

There is no set amount of cement that is injected to stabilize the fracture; however, it is thought that filling 50-70% of the residual volume of the compressed vertebra will provide appropriate pain relief. The amount of required cement is an approximation that varies with the different levels of the spine, with the lumbar region requiring more (4-8mL) than the thoracic (2-4mL).  Large ranges are given here because the trend is towards less and less cement being injected.

The cement is injected through each needle, one at a time, under real-time fluoroscopic visualization to ensure appropriate dispersal within the vertebral body. Therefore, the cement is opacified enough with an agent (barium sulfate) to be visualized through fluoroscopy to ensure correct placement and to monitor for cement leak. Injection of the cement is delivered very slowly and only after three minutes of mixing time to ensure thickness of the cement. Extreme caution must be used to reduce the chance of canal leak. The goal is to visualize 100% of cement contained to the anterior and middle 1/3 of vertebral bone with no cement in the posterior 1/3 of the vertebral body.  Cement delivery should only be performed in the lateral projection to ensure no cement violates the posterior 1/3 of the vertebral body.

Any cement leak outside of the vertebral body or within the posterior 1/3 is indicative to discontinue further injection of the cement until it hardens. At that point the injecting of the cement may be resumed if no further leakage is noted. If there is still leakage, then switching to the other needle may cause dispersion of the cement to other areas within the vertebral body. To decrease the risk of leak it is important to allow the cement to harden appropriately before injecting it. Cement leaks are more common when a fracture is caused by malignant tumors with lytic lesions.

Occasionally a biopsy of the vertebra may be taken in order to rule out malignant causes of the fracture. Biopsies should be considered with any history of cancer, unusual fracture morphology, multiple level fractures, and fractures in populations who do not normally get VCF including all men, young females, African Americans, and Hispanics.

Once any necessary biopsies have been taken and the cement has been injected into the vertebral body, the cannulas should remain in place for several minutes to decrease the leak of cement through the subcutaneous tissues. Once the cement hardens over a few minutes, the cannulas are removed and the area is cleaned.

After the entry sites are cleaned and covered with a sterile bandage, the patient is observed for two hours in the supine position to assess for any neurological or cardio-respiratory changes, as well as side effects from the sedation or cement. If no complications arise in the two-hour observation period, then the patient is sent home and will follow up with their physician in the next week or so to evaluate the efficacy of the vertebroplasty or to treat additional fractures if necessary.

How Long Is Recovery From the Procedure?

The needle insertion sites may be sore for a few days; however, this discomfort is usually mild and will resolve. If persistent, severe pain should occur, then a complication such as infection, hematoma, or a cement leak may be present. One to two percent of patients will have a transient increase in pain after the vertebroplasty that is usually benign and is adequately treated by analgesics; however, pain relief is usually immediate.

Heavy lifting should be avoided for three months (nothing heavier than five pounds). After three months the patient can gradually increase lifting to normal. Walking and weight-bearing exercises are encouraged and bending can be done normally.  Some doctors may also prescribe a fitted back brace to decrease the chance of developing kyphosis.

What Are the Outcomes Data?

In the past few years, there has been a lot of research surrounding non-surgical procedures and their effectiveness in treating back pain associated with vertebral body fractures.  Patients who do not respond to the more conservative management described above may be good candidates for minimally-invasive procedures that have been proven effective, including vertebroplasty and Balloon kyphoplasty.  Results of clinical research trials have concluded that both vertebroplasty and balloon kyphoplasty significantly reduce pain and improve mobility in patients with vertebral compression fractures.

In a 2007 report it was noted that 95% of people treated with these two procedures showed partial or complete immediate pain relief.  There have been several large studies that examined the outcomes of percutaneous vertebroplasty for compression fractures.   In a recent study, 100 consecutive patients with compression fractures were chosen and evaluated before and after undergoing vertebroplasty. Ninety-seven (97%) of the patients reported substantial pain relief 24 hours after treatment and 3% reported no change. Ninety-one percent reduced their daily intake of oral analgesic required to significantly alleviate their pain.

In a non-randomized comparison study, 126 patients with acute osteoporotic vertebral fractures were analyzed, 70% of the patients were treated with percutaneous vertebroplasty and the other group was treated with conservative medical management (30%).  The group who underwent vertebroplasty reported a 60% reduction in pain.  Pain scores were evaluated using a scale of zero to 20, and the group who received the vertebroplasty reported a decrease of pain from 20 to eight (p less than .001) with vertebroplasty and 43% reduction in total number of hospital bed stays.

A recent systematic review of all the available data presented in peer-reviewed published clinical trials showed 87% relief of pain with vertebroplasty. Patients’ reported VAS (visual analog scores) were reduced from 8.2 to 3.0 with a 95% confidence interval (2.4-3.6).

Presently there is a lack of blinded randomized clinical trials comparing the efficacy of medical management versus percutaneous vertebroplasty. This may be due to the fact that there is significant pain relief and function improvement seen with vertebroplasty that physicians would be hesitant to deny their patient this effective treatment.

Case Study

CHIEF COMPLAINT: Mid back pain

HPI:  Patient is a very pleasant 83-year-old female with a ten-year history of osteoporosis and HTN presenting with a four-week history of severe mid-back pain without radiation.   The pain began after leaning over to lift a bag of groceries from her car and has gradually increased in severity for the past few weeks.  Patient complains of VAS 9/10 in the mid-thoracic spine which has not responded to conservative treatment, including rest and pain medications.  Pt also denies any sensory or motor changes in the lower extremities.  No bowel or urinary incontinence.  Pain is constant and made worse with activity, which has led her to lie in bed for the last seven days.  Pt denies nausea, vomiting, fever, chills, localized areas of swelling, or redness.  Pt denies any unexpected or dramatic weight loss.

Past Medical History: Osteoporosis, HTN

Surgical History:  Pt has had no previous lumbar surgeries

Family History: Noncontributory

Allergies: NKDA

Current Medications: Fosamax, ASA, HCTZ

Relevant Physical Exam:

Thoracic Spine:  Some mild tenderness to palpation over the lower thoracic facet joints with lumbar extension and rotation.  Some paraspinous musculature spasm.  No gross anatomical abnormalities.  Patient does have severe tenderness to palpation over spinous process of approximately T10. Decreased ROM with lumbar extension and flexion.

Neurological:
Straight Raise Leg:                                           R:  Neg; L: Neg
Upper Lumbar and Thoracic Facets TTP:    R:  POS; L: POS
Lower Lumbar Facets TTP:                            R:  neg; L: neg

Sacroiliac TTP:                                                  R:  Neg, L: Neg
FABERs:                                                             R:  Neg, L: Neg

Motor Upper Extremities
Shoulder extension (C5):            R:  5/5,   L:  5/5
Arm flexion (C6):                          R:  5/5,   L:  5/5
Arm extension (C7):                     R:  5/5,   L:  5/5
Wrist extensors (C8):                   R:  5/5,   L:  5/5
Hand grasp (T1):                           R:  5/5,   L:  5/5

Motor Lower Extremities
Hip flexion (L2):                         R:  5/5,   L:  5/5
Knee extension (L3):                 R:  5/5,   L:  5/5
Knee flexion (L4):                      R:  5/5,   L:  5/5
Ankle dorsiflexon (L5):             R:  5/5,   L:  5/5
Ankle plantar flexion (S1):       R:  5/5,   L:  5/5

DTRs:
Bicep (C5):                       R:  2+,   L:  2+
Brachioradialis (C6):     R:  2+,   L:  2+
Tricep (C7):                     R:  2+,   L:  2+
Patella (L2-4):                R:  2+,   L:  2+
Achilles (S1-2):               R:  2+,   L:  2+

Babinski:                       R:  Neg, L:  Neg

Sensation:                     RLE=LLE
RUE=LUE
Sharp:                           RLE=LLE
RUE=LUE
Soft                              RLE=LLE
RUE=LUE

Asessment

83-year-old female with history of osteoporosis with four-week h/o acute mid-back pain with minimal exertion.  Suspicious for thoracic vertebral compression fracture.

Plan:

Norco 5/325 one tab po TID for acute pain
Order STAT Thoracic MRI with STIR images to rule out vertebral fracture.
F/u after MRI

Thoracic Spine MRI:

1.  Moderate T10 compression fracture w/nearly 50% loss of central height.  25-50% loss of anterior vertebral body height and 25% loss of posterior vertebral body height (bowtie fracture).
2.  There is focal marrow edema w/in the T10 vertebral body which suggests a likely acute or sub-acute fracture.

F/U Appointment Plan:

Patient was explained risk/benefits/ alternatives of vertebroplasty for the relief of pain caused by the T10 compression fracture.  Patient agrees to procedure and was scheduled for T10 vertebroplasty.

Post-Operative Evaluation:

One week following the T10 vertebroplasty, the patient returns to clinic and reports an 80% relief of pain. VAS 2/10.  Patient and husband are both extremely pleased with the amount of pain relief obtained as well as the increased mobility.  Patient states that “It was like a miracle!” Neurological exam was normal.  Patient counseled closely on management of osteoporosis including a balanced diet, weight bearing exercises, vitamin D and calcium supplements, and the importance of taking a bisphosphonate.

References

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Images provided by Stryker Interventional Spine with permission.

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