Research about kyphoplasty

Because Kyphoplasty is a fairly new treatment for vertebral fracture, there were not very many outcome studies until recently. Now the National Center for Biomedical Information web site offers abstracts and sometimes full texts for numerous studies.

Many of these studies compare the procedure with Vertebroplasty. If you wish to read these studies go to National Center for Biomedical Information anddo a search for the procedure.

Abstracts and summaries:

• "Back Pain, Vertebroplasty, and Kyphoplasty: Treatment of Osteoporotic Vertebral Compression Fractures" by S. Bobo Tanner MD. Journal of Rheumatic Diseases. vol 52;no 2. states, in part:

  "Kyphoplasty is the newer of the 2 procedures, and, as such, there are fewer published reports. Outcomes analysis from Liebermann’s series of 30 patients and 70 kyphoplasty procedures showed significant improvement in bodily pain and physical function using SF-36 questionnaire data (8). In a multicenter kyphoplasty study with 340 patients and 376 kyphoplasty procedures, 90% of the patients reported pain relief (12). Another retrospective analysis of 1,439 patients and 2,194 kyphoplasty procedures revealed pain relief in 90% of the patients within 2 weeks of the procedures (12). Other studies have noted that 75% of those patients who obtain pain relief gain it immediately after the procedure, and the remainder of those who will get pain relief experience it within the first 4 weeks after procedure (12).

  One of the benefits of kyphoplasty is the restoration of vertebral height. A study using cadaveric specimens showed an average 97% restoration of vertebral height with kyphoplasty versus an average 30% restoration of height with vertebroplasty (14). The ability to restore vertebral height appears to be a function of the elapsed time from the fracture, and the earlier procedure is performed, the greater benefits. Studies have noted 92% restoration of height if the procedure is done within 3 months of symptom onset, but only a 35% increase in vertebral height if it is done 5 months or more after of the onset of symptoms. The average height restoration in a multicenter trial was between 54% and 61% (12)." http://www.arthritis.org/research/Bulletin/Vol52No2/Clinical.asp

• Comparison study: "Minimal invasive stabilization of osteoporotic vertebral fractures: a prospective nonrandomized comparison of vertebroplasty and balloon kyphoplasty." by

  Grohs JG, Matzner M, Trieb K, Krepler P. J Spinal Disord Tech. 2005 Jun;18(3):238-4.

  "CONCLUSIONS: In nonrecent fractures, the reduction of the kyphotic wedge by balloon kyphoplasty was superior in decreasing pain persisting over a period of 2 years. The ability to improve disability after kyphoplasty was limited to 1 year. In nonrecent fractures, the consequences of age and osteoporosis seem to equalize the effects of the restored sagittal profile on disability but not on pain."

• "Treatment of osteoporotic vertebral compression. Explosive interest for vertebroplasty and kyphoplasty" by

  Karlsson MK, Hasserius R, Gerdhem P, Obrant KJ, Ohlin A. Lakartidningen. 2005 May 23-29;102(21):1644-6, 1648.

  "During the last 15 years, two new treatment strategies have gained worldwide attention in the treatment of osteoporotic vertebral fractures. The exponential increase in the use of percutaneous vertebro- or kyphoplasty has up to now not been supported by scientific sound evidence-based data. There exist no prospective randomised controlled trials (RCT) that support the efficacy of the treatments, not even adequate controlled studies. Instead we have to rely on prospective and retrospective uncontrolled short-term observational studies and case-control studies. These studies consistently indicate that the short-term results after the procedures in the treatment of osteoporotic vertebral fractures are favourable, regarding both pain relief and functional status. However, if a vertebro- or a kyphoplasty produces a better outcome than conservative treatment, and if the long-term results are as favourable as the short-term results in the treatment of osteoporotic vertebral fractures, is currently unknown."

• "Treatment of painful vertebral fractures by kyphoplasty in patients with primary osteoporosis: a prospective nonrandomized controlled study." by Trk C, Hillmeier J, Noldge G, Grafe IA, Dafonseca K, Raupp D, Bardenheuer H, Libicher M, Liegibel UM, Sommer U, Hilscher U, Pyerin W, Vetter M, Meinzer HP, Meeder PJ, Taylor RS, Nawroth P.in Bone Miner Res. 2005 Apr;20(4):604-12. Epub 2004 Dec 6. " This study investigates the effects of kyphoplasty on pain and mobility in patients with osteoporosis and painful vertebral fractures compared with conventional medical management.

  INTRODUCTION: Pharmacological treatment of patients with primary osteoporosis does not prevent pain and impaired activity of patients with painful vertebral fractures. Therefore, we evaluated the clinical outcome after kyphoplasty in patients with vertebral fractures and associated chronic pain for >12 months.

  MATERIALS AND METHODS: Sixty patients with primary osteoporosis and painful vertebral fractures presenting for >12 months were included in this prospective, nonrandomized controlled study. Twenty-four hours before performing kyphoplasty, the patients self-determined their inclusion into the kyphoplasty or control group so that 40 patients were treated with kyphoplasty, whereas 20 served as controls. This study assessed changes in radiomorphology, pain visual analog scale (VAS) score, daily activities (European Vertebral Osteoporosis Study [EVOS] score), number of new vertebral fractures, and health care use. Outcomes were assessed before treatment and at 3 and 6 months of follow-up.

  All patients received standard medical treatment (1g calcium, 1000 IE vitamin D(3), standard dose of oral aminobisphosphonate, pain medication, physical therapy). RESULTS: Kyphoplasty increased midline vertebral height of the treated vertebral bodies by 12.1%, whereas in the control group, vertebral height decreased by 8.2% (p = 0.001). Augmentation and internal stabilization by kyphoplasty resulted in a reduction of back pain. VAS pain scores improved in the kyphoplasty group from 26.2 +/- 2 to 44.2 +/- 3.3 (SD; p = 0.007) and in the control group from 33.6 +/- 4.1 to 35.6 +/- 4.1 (not significant), whereas the EVOS score increased in the kyphoplasty group from 43.8 +/- 2.4 to 54.5 +/- 2.7 (p = 0.031) and in the control group from 39.8 +/- 4.5 to 43.8 +/- 4.6 (not significant). The number of back pain-related doctor visits within the 6-month follow-up period decreased significantly after kyphoplasty compared with controls: mean of 3.3 visits/patient in the kyphoplasty group and a mean of 8.6 visits/patient in the control group (p = 0.0147).

  CONCLUSIONS: The results of this study show significantly increased vertebral height, reduced pain, and improved mobility in patients after kyphoplasty. Kyphoplasty performed in appropriately selected osteoporotic patients with painful vertebral fractures is a promising addition to current medical treatment."

Research finding complications

• "A review of complications associated with vertebroplasty and kyphoplasty as reported to the Food and Drug Administration medical device related web site." by Nussbaum DA, Gailloud P, Murphy K. J Vasc Interv Radiol. 2004 Nov;15(11):1185-92.

  "In 2002, approximately 38,000 vertebroplasties and 16,000 kyphoplasties were performed in the United States. As the use of both modalities for the treatment of vertebral compression fractures has increased, so have questions regarding safety and efficacy. The authors addressed this by reviewing both the current literature and complications data reported to the Food and Drug Administration (FDA) Center for Devices and Radiological Health through the on-line database (http://www.fda.gov/cdrh/maude.html) and through the Office of the Freedom of Information Act at the FDA.

  Although both procedures are largely safe, the FDA data highlight two main concerns: reactions to the use of acrylic (polymethylmethacrylate) bone cement, including hypotension and, in some cases, death, especially when multiple vertebral levels are treated in one setting; and a possible increased risk with kyphoplasty of pedicle fracture and cord compression."

• Cement complications. "FDA Complications Related to the Use of Bone Cement and Bone Void Fillers in Treating Compression Fractures of the Spine". Original Publication: October 31, 2002

  "Complications with bone cements and bone void fillers. Leakage of bone cements can result in soft tissue damage as well as nerve root pain and compression. Other reported complications generally associated with the use of bone cements in the spine include pulmonary embolism, respiratory and cardiac failure, abdominal intrusions/ileus, and death. Each of these types of complications has been reported in conjunction with use of these products in both vertebroplasty and kyphoplasty procedures.

  Reported complications associated with the use of bone void fillers in the spine include pulmonary embolism, respiratory and cardiac failure, and death. Bone void fillers are cleared for use only in non load bearing applications. Under ideal conditions, these bone void fillers resorb over time and are replaced with new bone growth. Bone growth in osteoporotic patients or in load bearing applications (e.g. a vertebral compression fracture) has not been adequately studied to support marketing applications."