Management of Osteoporotic Vertebral Compression Fractures

Scroll down to respond to the OrthopaedicsOne Poll: Kyphoplasty should be the first-line treatment for patients with osteoporotic vertebral compression fractures

The debate over the best management for osteoporotic vertebral compression fractures is presented in this Viewpoints article.

Viewpoint 1: Michael G. Johnson, MD, FRCSC

Comparative Effectiveness of Kyphoplasty for Osteoporotic Insufficiency Fractures

It is estimated that age-related osteoporotic vertebral compression fractures (VCFs) occur in more than 500,000 patients per year in the United States. Failed nonsurgical management may lead to persistent pain and may require surgical intervention.

Minimally invasive methods of treating the symptoms of spinal compression fractures have generated considerable interest over the last two decades. Widely accepted treatment algorithms for the nonsurgical and surgical management of painful osteoporotic compression fractures have yet to be clearly established.2-4 The goal of this article is to examine the comparative effectiveness of kyphoplasty versus vertebroplasty and nonsurgical management of osteoporotic insufficiency fractures.

Vertebroplasty describes the percutaneous augmentation of a vertebral body by a hardening material and was originally used to manage painful neoplastic lesions. Kyphoplasty refers to the procedure of filling a void in a vertebral body created by an inflatable balloon that elevates the depressed superior end plate (Figures 1-3). Cavity creation systems that do not elevate the superior end plate are available as well, but they create a void that facilitates low-pressure injection. The surgically created void is then filled with a low-pressure, high-viscosity hardening support material. Polymethylmethacrylate (PMMA) is commonly used.

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Figure 1. The balloon is inflated creating a cavity and compacting the bone around the balloon with elevation of the fractured cortices.


Figure 2. The balloon is removed, a bone filler device is inserted through the cannula, and cement is injected (packed) into the void.


Figure 3. A 77-year-old man presented with a 4-month history of unremitting mid-back pain that limited ambulation and functional ability and required narcotic use. A: Standing lateral radiograph demonstrating an anterior compression deformity of T9. B: Supine extension lateral radiograph demonstrating an intervertebral defect (arrow) just below the superior end plate. C: T2-weighted sagittal MRI scan demonstrating the fluid-filled intervertebral cleft characteristic of a fracture nonunion. Anteroposterior (D) and lateral (E) intraoperative fluoroscopic views with bone tamps inflated. F: Postoperative lateral radiograph after stabilization using percutaneous kyphoplasty.

Nonsurgical treatment for VCFs includes bed rest, analgesics, and bracing. Limitations of this approach include the inability to restore spinal alignment and associated lack of mobility, which itself may result in an increased rate of demineralization over the duration of bed rest. In comparison, kyphoplasty has been reported to result in substantial initial symptomatic functional improvement (90%) and restoration of the anterior, middle and posterior vertebral body height when performed within three months of the onset of the fracture.

A Phase I efficacy trial of 70 consecutive kyphoplasty levels in 30 patients using SF-36 showed significant (p < 01) improvement in bodily pain, physical function, vitality, mental health, and social functioning at a mean follow-up of 6.7 months. Only general health and emotional scores did not show significant improvement. Seventy-percent of total levels showed average height restoration of 47%. Two-year follow-up of a single-center consecutive case series reported improvement in pain and function with normalization of morphologic shape indexes that remained stable during follow-up. This may be the longest follow-up reported to date.10

Complications appear to be relatively infrequent.5,11-15 Cement extravasation as well as rib fractures have been reported.10 One case of pulmonary edema and myocardial infarction was attributed to fluid overload. Other reported complications include transient fever, hypoxia and postoperative epidural hematoma (associated with a heparin bolus postoperatively). Garfin et al reported two cases of neurologic injury secondary to problems with needle insertion and positioning of the cement filling tube causing epidural cement extravasation. Intraoperative balloon rupture occurred 14 times, mostly at the end of inflation. All broken bone tamps were easily removed. No direct patient complication occurred due to balloon failure.

An important theoretical concern after the procedure is the possibility of increased force on the vertebra adjacent to a cement-injected level, with an increase in adjacent segment fracture rate. A new fracture rate of 19% has been reported (22/115) patients. Seven of the 22 patients had new fractures adjacent to injected levels.16 Although the natural history has yet to be conclusively established, a new fracture rate has been reported at 6.6% in the first year after diagnosis of one VCF and 19.2 % within the next year.17

Caution must be exercised regarding interpretation of the published reports, especially considering the level of evidence required to accept a new treatment as having a positive treatment effect. Methodologically, the kyphoplasty evidence consists of case series; a randomized trial has yet to report. A reported positive treatment effect in a case series is considered weak evidence overall.18 As kyphoplasty publications are non-comparative, they should be considered as hypothesis-generating as opposed to hypothesis-confirming, and one cannot advocate kyphoplasty as superior treatment over vertebroplasty or indeed over nonsurgical methods. In fact, a comparative trial of calcitonin in the treatment of painful VCFs demonstrates a convincing benefit over placebo, reducing pain and shortening time to mobilization.19

Given the available evidence, it is reasonable to surmise that kyphoplasty is a safe procedure with infrequently reported complications, enabling the low-pressure injection of a hardening material into vertebral bodies that have sustained a VCF, and that the inflation of the balloon is more effective at restoring vertebral endplate alignment after VCFs than vertebroplasty. The clinical significance of this local restoration of end-plate alignment and the resultant effect on overall sagittal balance is unclear, given the absence of comparative reports between kyphoplasty and vertebroplasty. In addition, the comparative effectiveness of kyphoplasty relative to nonsurgical management or the natural history of VCFs has also not been convincingly established. The lack of clarity for the role of kyphoplasty in VCFs may assume more significance when one considers the cost factor which has not been reported.

Reprinted with permission from the February/March 2006 issue of COA Bulletin

References

  1. Melton LJ, 1997. “Epidemiology of spinal osteoporosis.”Spine (Phila Pa 1976) 22(24 Suppl):2S-11S
  2. Mathis JM, Petri M, Naff N, 1998. “Percutaneous vertebroplasty treatment of steroid-induced osteoporotic compression fractures.”Arthritis Rheum 41(1):171-5
  3. Jensen GF, Christiansen C, Boesen J, Hegedüs V, Transbøl I, 1982. “Epidemiology of postmenopausal spinal and long bone fractures. A unifying approach to postmenopausal osteoporosis.”Clin Orthop Relat Res (166):75-81
  4. Melton LJ, Kan SH, Frye MA, Wahner HW, O’Fallon WM, Riggs BL, 1989. “Epidemiology of vertebral fractures in women.”Am J Epidemiol 129(5):1000-11
  5. Galibert P, Deramond H, Rosat P, Le Gars D, 1987. “Preliminary note on the treatment of vertebral angioma by percutaneous acrylic vertebroplasty.” Neurochirurgie 33(2):166-8
  6. Spivak JM, Johnson MG, 2005 Jan-Feb. “Percutaneous treatment of vertebral body pathology.”J Am Acad Orthop Surg 13(1):6-17
  7. Heaney RP, 1992. “The natural history of vertebral osteoporosis. Is low bone mass an epiphenomenon?”Bone 13(Suppl 2):S23-6
  8. Garfin SR, Yuan HA, Reiley MA, 2001. “New technologies in spine: kyphoplasty and vertebroplasty for the treatment of painful osteoporotic compression fractures.”Spine (Phila Pa 1976) 26(14):1511-5
  9. Lieberman IH, Dudeney S, Reinhardt MK, Bell G, 2001. “Initial outcome and efficacy of “kyphoplasty” in the treatment of painful osteoporotic vertebral compression fractures.”Spine (Phila Pa 1976) 26(14):1631-8
  10. Ledlie JT, Renfro MB, 2006. “Kyphoplasty treatment of vertebral fractures: 2-year outcomes show sustained benefits.” Spine (Phila Pa 1976) 31(1):57-64
  11. Cotten A, Dewatre F, Cortet B, et al, 1996. “Percutaneous vertebroplasty for osteolytic metastases and myeloma: effects of the percentage of lesion filling and the leakage of methyl methacrylate at clinical follow-up.” Radiology 200(2):525-30
  12. Weill A, Chiras J, Simon JM, Rose M, Sola-Martinez T, Enkaoua E, 1996. “Spinal metastases: indications for and results of percutaneous injection of acrylic surgical cement.” Radiology 199(1):241-7
  13. Gangi A, Kastler BA, Dietemann JL, 1994. “Percutaneous vertebroplasty guided by a combination of CT and fluoroscopy.” AJNR Am J Neuroradiol 15(1):83-6
  14. Kaemmerlen P, Thiesse P, Bouvard H, Biron P, Mornex F, Jonas P, 1989. “Percutaneous vertebroplasty in the treatment of metastases. Technic and results.” J Radiol 70(10):557-62
  15. Moreland DB, Landi MK, Grand W, 2001 Jan-Feb. “Vertebroplasty: techniques to avoid complications.” Spine J 1(1):66-71
  16. 2002 Sep-Oct. “Abstracts of the North American Spine Society 17th Annual Meeting. Montreal, Canada, October 29-November 2, 2002.” Spine J 2(5 Suppl):45S-133S
  17. Lindsay R, Silverman SL, Cooper C, et al. 2001. “Risk of new vertebral fracture in the year following a fracture.” JAMA 285(3):320-3
  18. Lyles KW, 1999. “Management of patients with vertebral compression fractures.” Pharmacotherapy 19(1 Pt 2):21S-24S
  19. Ringe JD, Orwoll E, Daifotis A, Lombardi A, 2002. “Treatment of male osteoporosis: recent advances with alendronate.”Osteoporos Int 13(3):195-9

Viewpoint 2: Garth E. Johnson, MD, FRCSC

Nonoperative Management of Osteoporotic Vertebral Fractures

The spectrum of osteoporotic vertebral fractures is extremely large, ranging from asymptomatic vertebral wedging, which increases with aging, to acute symptomatic fractures occurring with minimal injury. The quoted prevalence of vertebral fractures depends primarily on the criteria for diagnosis, with some variation from one population to another.1-3

Generally speaking, a 9% to 12% incidence is given for middle-aged women, with a correlation among vertebral fracture prevalence and bone mineral density in the lumbar spine, height loss, and chronic back symptoms.

The male to female ratio also seems quite variable, varying from 2 to 1 in European population to a high of 4 to 1 in patients referred to a metabolic bone disease clinic. Several reports have shown a higher incidence in men aged 45 to 54 in populations exposed to physically demanding activities, which may be due to occupationally related vertebral fractures. The incidence is higher in Caucasians and Asians than in persons of dark skin color.

The factor of risk is an indication as to whether a fracture is likely during a given activity. The factor of risk is the ratio of the force applied to a bone during an activity divided by the force at which the bone fractures. A factor of risk higher than 1 indicates that the bone is overloaded and failure is likely.

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Eastell et al have classified vertebral fractures on the basis of their radiographic appearance. The distribution and type varied between their general population and that of women referred to the clinic with suspected osteoporosis.

Fragility fractures of the spine do not have the same initial impact as fractures of the hip. The disability related to these vertebral fractures is correlated with age and kyphosis, including postural changes and loss of height. When the kyphosis is greater than four standard deviations, chronic pain becomes a significant contributing factor to late disability. Four percent of patients with a vertebral fracture become completely dependent because of the fracture.

As expected, survivorship studies indicate a significant increase in mortality within 1 year of the diagnosis of the insufficiency fracture of the hip. After this point, however, the mortality rate then parallels the age-matched non-fracture group. The mortality rate associated with insufficiency fractures of the vertebrae shows a progressive increase over a much longer period of time, even when controlled for underlying comorbidities. Women with radiographic evidence of vertebral fractures have an increased mortality rate, particularly from pulmonary disease and cancer.

The prevention of vertebral insufficiency fractures parallels those measures for the maintenance of bone mineral density, with special focus on dietary intake of sufficient elemental calcium and vitamin D. Hormone replacement therapy remains controversial. Moderate physical activity in people with osteoporosis may stimulate bone gain and/or decrease bone loss but its effects are an adjunct to other interventions. Other benefits of physical activity are:

  • Reduction of fall risk
  • Decreased pain and improved fitness
  • Overall quality of life8-16

Bisphosphonate may be considered an alternative to ovarian hormone therapy in post-menopausal, osteopenic, or osteoporotic women, especially those who cannot or will not tolerate hormone replacement therapy. It is effective in men with osteoporosis for improving bone mass and preventing fracture. Alendronate therapy significantly decreases the risk of new vertebral fracture in post-menopausal women with osteoporosis who present with a new vertebral fracture. It also decreases the number of days of disability and days of limited activity caused by back pain.17

Many insufficiency fractures that are symptomatic or minimally symptomatic can be treated symptomatically with altered activity and analgesics, with expected improvement over a 1- to 2-month period. Calcitonin has been shown to given significant relief of pain, perhaps more from the release of endogenous opioids than an early direct effect on fracture healing.

Spinal orthoses are not effective for fractures above the T6 level. In acute fractures, pain relief can be obtained by use of a lumbosacral corset or chairback brace. For wedge deformity fractures, a Jewett brace will provide sagittal plane support, which may be important to avoid progression of the wedging. However, fractures contributing to progression of kyphosis have often occurred at different times so that some of the fractures contributing to the deformity may be old and healed.18

The Jewett orthosis is not well tolerated in older patients, is cumbersome to apply, creates a problem for sitting, and is not well tolerated in a patient who already has significant kyphosis.

Fractures caused by axial load, such as biconcave and compression fractures, could be treated by a TLSO within the limitations already mentioned.

There are no clear guidelines as to which fractures are not amenable to nonoperative measures. The main indications for consideration of more invasive treatment are fractures remaining symptomatic or becoming increasingly symptomatic after the 4- to 8-week interval, or perhaps fractures that have an intraosseus vacuum phenomenon.

Reprinted with permission from the February/March 2006 issue of COA Bulletin

References

  1. Black DM, Palermo L, Nevitt MC, Genant HK, Christensen L, Cummings SR, 1999. “Defining incident vertebral deformity: a prospective comparison of several approaches. The Study of Osteoporotic Fractures Research Group.” J Bone Miner Res 14 (1): 90-101
  2. Sauer P, Leidig G, Minne HW, Duckeck G, Schwarz W, Siromachkostov L, Ziegler R, 1991. “Spine deformity index (SDI) versus other objective procedures of vertebral fracture identification in patients with osteoporosis: a comparative study.” J Bone Miner Res 6 (3): 227-38
  3. Kiel D, 1995. “Assessing vertebral fractures. National Osteoporosis Foundation Working Group on Vertebral Fractures.” J Bone Miner Res 10 (4): 518-23
  4. Melton LJ, 1997. “Epidemiology of spinal osteoporosis.”Spine (Phila Pa 1976)22 (24 Suppl):2S-11S
  5. Myers ER, Wilson SE, 1997. “Biomechanics of osteoporosis and vertebral fracture.”Spine (Phila Pa 1976)22 (24 Suppl): 25S-31S
  6. Eastell R, Cedel SL, Wahner HW, Riggs BL, Melton LJ, 1991. “Classification of vertebral fractures.”J Bone Miner Res 6(3):207-15
  7. Ettinger B, Black DM, Nevitt MC, Rundle AC, Cauley JA, Cummings SR, Genant HK, 1992. “Contribution of vertebral deformities to chronic back pain and disability. The Study of Osteoporotic Fractures Research Group.”J Bone Miner Res 7(4):449-56 
  8. Hanley DA, Josse RG, 1996. “Prevention and management of osteoporosis: consensus statements from the Scientific Advisory Board of the Osteoporosis Society of Canada. 1. Introduction.”CMAJ 155(7):921-3
  9. Sturtridge W, Lentle B, Hanley DA, 1996. “Prevention and management of osteoporosis: consensus statements from the Scientific Advisory Board of the Osteoporosis Society of Canada. 2. The use of bone density measurement in the diagnosis and management of osteoporosis.”CMAJ 155(7):924-9
  10. Josse RG, 1996. “Prevention and management of osteoporosis: consensus statements from the Scientific Advisory Board of the Osteoporosis Society of Canada. 3. Effects of ovarian hormone therapy on skeletal and extraskeletal tissues in women.”CMAJ 155(7):929-34
  11. Murray TM, 1996. “Prevention and management of osteoporosis: consensus statements from the Scientific Advisory Board of the Osteoporosis Society of Canada. 4. Calcium nutrition and osteoporosis.”CMAJ 155(7):935-9
  12. Prior JC, Barr SI, Chow R, Faulkner RA, 1996. “Prevention and management of osteoporosis: consensus statements from the Scientific Advisory Board of the Osteoporosis Society of Canada. 5. Physical activity as therapy for osteoporosis.”CMAJ 155(7):940-4
  13. Hodsman A, Adachi J, Olszynski W, 1996. “Prevention and management of osteoporosis: consensus statements from the Scientific Advisory Board of the Osteoporosis Society of Canada. 6. Use of bisphosphonates in the treatment of osteoporosis.”CMAJ 155(7):945-8
  14. Murray TM, Ste-Marie LG, 1996. “Prevention and management of osteoporosis: consensus statements from the Scientific Advisory Board of the Osteoporosis Society of Canada. 7. Fluoride therapy for osteoporosis.”CMAJ 155(7):949-54
  15. Jones G, Hogan DB, Yendt E, Hanley DA, 1996. “Prevention and management of osteoporosis: consensus statements from the Scientific Advisory Board of the Osteoporosis Society of Canada. 8. Vitamin D metabolites and analogs in the treatment of osteoporosis.”CMAJ 155(7):955-61
  16. Siminoski K, Josse RG, 1996. “Prevention and management of osteoporosis: consensus statements from the Scientific Advisory Board of the Osteoporosis Society of Canada. 9. Calcitonin in the treatment of osteoporosis.”CMAJ 155(7):962-5
  17. Nevitt MC, Thompson DE, Black DM, Rubin SR, Ensrud K, Yates AJ, Cummings SR, 2000. “Effect of alendronate on limited-activity days and bed-disability days caused by back pain in postmenopausal women with existing vertebral fractures. Fracture Intervention Trial Research Group.”Arch Intern Med 160(1):77-85
  18. Patwardhan AG, Li SP, Gavin T, Lorenz M, Meade KP, Zindrick M, 1990. “Orthotic stabilization of thoracolumbar injuries. A biomechanical analysis of the Jewett hyperextension orthosis.”Spine (Phila Pa 1976) 15(7):654-61

Reprinted with permission from the February/March 2006 issue of COA Bulletin

 

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