Research Reporting Standards for Percutaneous Vertebral Augmentation

Journal of Vascular and Interventional Radiology

Volumn 20, Issue 10, 2009, Pages 1279-1286

  Radvany, Martin G ^a   Murphy, Kieran J ^b   Millward, Steven F ^e,f   Barr, John Dean ^g   Clark, Timothy W I ^i,j   Halin, Neil J ^k   Kinney, Thomas B ^h   Kundu, Sanjoy ^c,d   Sacks, David ^l   Wallace, Michael J ⁿ   Cardella, John F ^m  

^a JOHNS HOPKINS HOSPITAL   (United States)

^b UNIVERSITY OF TORONTO   (Canada)

^c Vein Institute of Toronto   (Canada)

^d SCARBOROUGH HOSPITAL   (Canada)

^e UNIVERSITY OF WESTERN ONTARIO   (Canada)

^f Peterborough Regional Health Centre   (Canada)

^g LJR Medical Group   (United States)

^h UCSD MEDICAL CENTER   (United States)

ⁱ NEW YORK UNIVERSITY SCHOOL OF MEDICINE   (United States)

^j NEW YORK UNIVERSITY MEDICAL CENTER   (United States)

^k TUFTS MEDICAL CENTER   (United States)

^l READING HOSPITAL AND MEDICAL CENTER   (United States)

^m GEISINGER HEALTH SYSTEM   (United States)

ⁿ UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ANALGESIC AGENT; BISPHOSPHONIC ACID DERIVATIVE; CALCITONIN; CALCIUM; ESTROGEN; POLY(METHYL METHACRYLATE); VITAMIN D;

ANALGESIA; ARTICLE; BONE SCINTISCANNING; BRACE; CLINICAL EVALUATION; CLINICAL RESEARCH; COMPRESSION FRACTURE; CONSERVATIVE TREATMENT; DISEASE CLASSIFICATION; ESTROGEN THERAPY; EXERCISE; FRAGILITY FRACTURE; HEMANGIOMA; HIGH RISK POPULATION; HUMAN; KYPHOPLASTY; MEDICAL LITERATURE; NUCLEAR MAGNETIC RESONANCE IMAGING; OUTCOME ASSESSMENT; PERCUTANEOUS VERTEBROPLASTY; PERIPHERAL NERVE INJURY; POSTMENOPAUSE OSTEOPOROSIS; PREOPERATIVE EVALUATION; PRIORITY JOURNAL; PUBLICATION; SPINAL CORD DECOMPRESSION; SPINAL PAIN; SPINE METASTASIS; SPINE STABILIZATION; STANDARDIZATION; TREATMENT OUTCOME; VERTEBRA FRACTURE;

CLINICAL TRIALS AS TOPIC; HUMANS; PERIODICALS AS TOPIC; PRACTICE GUIDELINES AS TOPIC; RADIOGRAPHY, INTERVENTIONAL; SPINAL FRACTURES; UNITED STATES; VERTEBROPLASTY; WRITING;

EID: 70349451702     PISSN: 10510443     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jvir.2009.07.030     Document Type: Article

References (56)

1. Galibert P., Deramond H., Rosat P., et al. Preliminary note on the treatment of vertebral angioma by percutaneous acrylic vertebroplasty. Neurochirurgie 33 (1987) 166-168 [French]
2. Deramond H., Wright N.T., and Belkoff S.M. Temperature elevation caused by bone cement polymerization during vertebroplasty. Bone 25 suppl (1999) S17-S21
3. Jensen M.E., McGraw J.K., Cardella J.F., and Hirsch J.A. Position statement on percutaneous vertebral augmentation: a consensus statement developed by the American Society of Interventional and Therapeutic Neuroradiology, Society of Interventional Radiology, American Association of Neurological Surgeons/Congress of Neurological Surgeons, and American Society of Spine Radiology. J Vasc Interv Radiol 18 (2007) 325-330
4. Wardlaw D., Cummings S.R., Van Meirhaeghe J., et al. Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised controlled trial. Lancet 373 (2009) 1016-1024
5. Jensen M.E., Evans A.J., and Mathis J.M. Percutaneous polymethylmethacrylate vertebroplasty in the treatment of osteoporotic vertebral body compression fractures: technical aspects. AJNR Am J Neuroradiol 18 (1997) 1897-1904
6. Weill A., Chiras J., Simon J.M., Rose M., Sola-Martinez T., and Enkaoua E. Spinal metastases: indications for and results of percutaneous injection of acrylic surgical cement. Radiology 199 (1996) 241-247
7. Cotten A., Dewatre F., Cortet B., et al. 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 (1996) 525-530
8. Murphy K.J., and Deramond H. Percutaneous vertebroplasty in benign and malignant disease. Neuroimaging Clin N Am 10 (2000) 535-545
9. Siris E.S., Brenneman S.K., Barrett-Connor E., et al. The effect of age and bone mineral density on the absolute, excess, and relative risk of fracture in postmenopausal women aged 50-99: results from the National Osteoporosis Risk Assessment (NORA). Osteoporos Int 17 (2006) 565-574
10. Lane N.E. Epidemiology, etiology, and diagnosis of osteoporosis. Am J Obstet Gynecol 194 suppl (2006) S3-S11
11. Lin D.D., Gailloud P., and Murphy K.J. Percutaneous vertebroplasty in benign and malignant disease. Neurosurg Q 11 (2001) 290-301
12. Stalnikowicz R., and Rachmilewitz D. NSAID-induced gastroduodenal damage: is prevention needed?. A review and metaanalysis. J Clin Gastroenterol 17 (1993) 238-243
13. Silverstein F., Graham D., Senior J., et al. Misoprostol reduces gastrointestinal complications in patients with rheumatoid arthritis receiving nonsteroidal anti-inflammatory drugs: a randomized, double-blind, placebo-controlled trial. Ann Intern Med 123 (1995) 241-249
14. Kalso E., Edwards J.E., Moore R.A., and McQuay H.J. Opioids in chronic non-cancer pain: systematic review of efficacy and safety. Pain 112 (2004) 372-380
15. Hu S.S., Tribus C.B., Tay B.K., et al. Disorders, diseases and injuries of the spine. In: Skinner H.B. (Ed). Current Diagnosis and Treatment in Orthopedics (2003), McGraw-Hill, New York 237-239
16. Huskisson E.C. Measurement of pain. Lancet 2 (1974) 1127-1131
17. Fairbank J.C., Couper J., Davies J.B., and O'Brien J.P. The Oswestry low back pain disability questionnaire. Physiotherapy 66 (1980) 271-273
18. Fairbank J.C., and Pynsent P.B. The Oswestry Disability Index. Spine 25 (2000) 2940-2952
19. Roland M., and Morris R. A study of the natural history of back pain. Part I: development of a reliable and sensitive measure of disability in low-back pain. Spine 8 (1983) 141-144
20. Ware J.E. SF-36 health survey update. Spine 25 (2000) 3130-3139
21. Shiely J.C., Bayliss M.S., Keller S.D., et al. SF-36 health survey annotated bibliography: the first edition (1988-1995) (1996), The Health Institute, New England Medical Center, Boston
22. Maynard A.S., Jensen M.E., Schweickert P.A., Marx W.F., Short J.G., and Kallmes D.F. Value of bone scan imaging in predicting pain relief from percutaneous vertebroplasty in osteoporotic vertebral fractures. AJNR Am J Neuroradiol 21 (2000) 1807-1812
23. Genant H.K., Wu C.Y., van Kuyk C., et al. Vertebral fracture assessment using a semiquantitative technique. J Bone Miner Res 8 (1993) 1137-1148
24. Klazen C., Verhaar H., Lampmann L., et al. VERTOS II: percutaneous vertebroplasty versus conservative therapy in patients with painful osteoporotic vertebral compression fractures; rationale, objectives and design of a multicenter randomized controlled trial. Trials 8 (2007) 33
25. Trumm C.G., Jakobs T.F., Zech C.J., Helmberger T.K., Reiser M.F., and Hoffmann R. CT fluoroscopy-guided percutaneous vertebroplasty for the treatment of osteolytic breast cancer metastases: results in 62 sessions with 86 vertebrae treated. J Vasc Interv Radiol 19 (2008) 1596-1606
26. Gangi A., Kastler B.A., and Dietemann J.L. Percutaneous vertebroplasty guided by a combination of CT and fluoroscopy. AJNR Am J Neuroradiol 15 (1994) 83-86
27. Knight J.R., Heran M., Munk P.L., Raabe R., and Liu D.M. C-arm cone-beam CT: applications for spinal cement augmentation demonstrated by three cases. J Vasc Interv Radiol 19 (2008) 1118-1122
28. Lim T.H., Breback G.T., Renner S.M., et al. Biomechanical evaluation of an injectable calcium phosphate cement for vertebroplasty. Spine 27 (2002) 1297-1302
29. Lieberman I.H., Togawa D., and Kayanja M.M. Vertebroplasty and kyphoplasty: filler materials. Spine J 5 suppl (2005) S305-S316
30. Tanigawa N., Komemushi A., Kariya S., et al. Relationship between cement distribution pattern and new compression fracture after percutaneous vertebroplasty. AJR Am J Roentgenol 189 (2007) W348-W352
31. Lin W., Cheng T., Lee Y., et al. New vertebral osteoporotic compression fractures after percutaneous vertebroplasty: retrospective analysis of risk factors. J Vasc Interv Radiol 19 (2008) 225-231
32. Nussbaum D.A., Gailloud P., and Murphy K. A review of complications associated with vertebroplasty and kyphoplasty as reported to the Food and Drug Administration medical device related web site. J Vasc Interv Radiol 15 (2004) 1185-1192
33. Anselmettice GC, Carpeggiani P. Multiple levels vertebroplasty: feasibility, safety and efficacy. Presented at the Ninth Congress of the World Federation of Interventional and Therapeutic Neuroradiology (WFITN); September 9-13, 2007; Beijing, China.
34. Yu S., Yang S., Kao Y., Yen C., Tu Y., and Chen L. Clinical evaluation of vertebroplasty for multiple-level osteoporotic spinal compression fracture in the elderly. Arch Orthop Trauma Surg 128 (2008) 97-101
35. Hodler J., Peck D., and Gilula L.A. Midterm outcome after vertebroplasty: predictive value of technical and patient-related factors. Radiology 227 (2003) 662-668
36. Garfin S.R., Yuan H.A., and Reiley M.A. New technologies in spine: kyphoplasty and vertebroplasty for the treatment of painful osteoporotic compression fractures. Spine 26 (2001) 1511-1515
37. Pflugmacher R., Beth P., Schroeder R., Schaser K., and Melcher I. Balloon kyphoplasty for the treatment of pathological fractures in the thoracic and lumbar spine caused by metastasis: one-year follow-up. Acta Radiol 48 (2007) 89-95
38. Phillips F.M., Ho E., Campbell-Hupp M., McNally T., Todd Wetzel F., and Gupta P. Early radiographic and clinical results of balloon kyphoplasty for the treatment of osteoporotic vertebral compression fractures. Spine 28 (2003) 2260-2265
39. Ledlie J.T., and Renfro M. Balloon kyphoplasty: one-year outcomes in vertebral body height restoration, chronic pain, and activity levels. J Neurosurg 98 (2003) 36-42
40. Rhyne A.I., Banit D., Laxer E., Odum S., and Nussman D. Kyphoplasty: report of eighty-two thoracolumbar osteoporotic vertebral fractures. J Orthop Trauma 18 (2004) 294-299
41. Hulme P.A., Krebs J., Ferguson S.J., et al. Vertebroplasty and kyphoplasty: a systematic review of 69 clinical studies. Spine 17 (2006) 1983-2001
42. Phillips F.M., Todd Wetzel F., Lieberman I., and Campbell-Hupp M. An in vivo comparison of the potential for extravertebral cement leak after vertebroplasty and kyphoplasty. Spine 27 (2002) 2173-2178
43. Pilitsis J., and Rengachary S.S. The role of vertebroplasty in metastatic spinal disease. Neurosurg Focus 11 (2001) e9
44. Nomura M, Komemushi A, Kamata M, et al. Does bone cement injected to vertebra affect radiotherapy dose distribution? Presented at the 33rd Annual Scientific Meeting of the Society of Interventional Radiology; March 19, 2008; Washington, DC.
45. Schaefer O., Lohrmann C., Markmiller M., Uhrmeister P., and Langer M. Combined treatment of a spinal metastasis with radiofrequency heat ablation and vertebroplasty. AJR Am J Roentgenol 180 (2003) 1075-1077
46. Toyota N., Naito A., Kakizawa H., et al. Radiofrequency ablation therapy combined with cementoplasty for painful bone metastases: initial experience. Cardiovasc Intervent Radiol 28 (2005) 578-583
47. Miller D.L., Balter S., Wagner L.K., et al. Quality improvement guidelines for recording patient radiation dose in the medical record. J Vasc Interv Radiol 15 (2004) 423-429
48. McGraw K., Cardella J., Barr J.D., et al. Society of Interventional Radiology quality improvement guidelines for percutaneous vertebroplasty. J Vasc Interv Radiol 14 suppl (2003) S311-S315
49. Kim Y.J., Lee J.W., Park K.W., et al. Pulmonary cement embolism after percutaneous vertebroplasty in osteoporotic vertebral compression fractures: incidence, characteristics, and risk factors. Radiology 251 (2009) 250-259
50. Knight R. KAVIAR study-kyphoplasty and vertebroplasty in the augmentation and restoration of vertebral body compression fractures. http://clinicaltrials.gov/ct2/show/NCT00323609 Accessed February 21, 2009
51. Kallmes D.F. Vertebroplasty for the treatment of fractures due to osteoporosis. http://clinicaltrials.gov/ct2/show/NCT00068822 Accessed February 21, 2009
52. Weill A., Chiras J., Simon J.M., Rose M., Sola-Martinez T., and Enkaoua E. Spinal metastases: indications for and results of percutaneous injection of acrylic surgical cement. Radiology 199 (1996) 241-247
53. Jensen M.E., Evans A.J., Mathis J.M., Kallmes D.F., Cloft H.J., and Dion J.E. Percutaneous polymethylmethacrylate vertebroplasty in the treatment of osteoporotic vertebral body compression fractures: technical aspects. AJNR Am J Neuroradiol 18 (1997) 1897-1904
54. Ha K., Lee J., Kim K., and Chon J. Percutaneous vertebroplasty for vertebral compression fractures with and without intravertebral clefts. J Bone Joint Surg Br 88 (2006) 629-633
55. Begg C., Cho M., Eastwood S., et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA 276 (1996) 637-639
56. Guidance for Industry and FDA Staff-clinical trial considerations: vertebral augmentation devices to treat spinal insufficiency fractures. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072301.htm Accessed June 1, 2009