High-dose rhBMP-2 for adults: Major and minor complications

Journal of Bone and Joint Surgery

Volumn 95, Issue 17, 2013, Pages 1546-1553

  Mesfin, Addisu ^a   Buchowski, Jacob M ^b   Zebala, Lukas P ^b   Bakhsh, Wajeeh R ^b   Aronson, Adam B ^b   Fogelson, Jeremy L ^b   Hershman, Stuart ^b   Kim, Han Jo ^b   Ahmad, Azeem ^b   Bridwell, Keith H ^b  

^a UNIVERSITY OF ROCHESTER   (United States)

^b WASHINGTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

RECOMBINANT BONE MORPHOGENETIC PROTEIN 2; BMP2 PROTEIN, HUMAN; BONE MORPHOGENETIC PROTEIN 2; RECOMBINANT PROTEIN;

ACOUSTIC NEURINOMA; ADULT; ARTICLE; BLADDER CANCER; BREAST CANCER; COLON CANCER; CYST; DRUG MEGADOSE; EPIDURAL HEMATOMA; FEMALE; FOLLOW UP; HEMATOTHORAX; HUMAN; IDIOPATHIC SCOLIOSIS; KIDNEY CARCINOMA; KYPHOSIS; LOWER EXTREMITY SARCOMA; LUMBAR SPINE; LUNG CANCER; LUNG EDEMA; MAJOR CLINICAL STUDY; MALE; OVARY CANCER; PEROPERATIVE COMPLICATION; PRIORITY JOURNAL; PSEUDARTHROSIS; RADICULOPATHY; RETROGRADE EJACULATION; SARCOMA; SEROMA; SKIN CARCINOMA; SPINE SURGERY; SURGICAL INFECTION; THORACIC SPINE; WOUND INFECTION; ADOLESCENT; AGED; CHEMICALLY INDUCED DISORDER; INCIDENCE; LUMBAR VERTEBRA; METHODOLOGY; MIDDLE AGED; POSTOPERATIVE COMPLICATION; RETROSPECTIVE STUDY; SPINE DISEASE; SPINE FUSION; VERTEBRA; VERY ELDERLY;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; BONE MORPHOGENETIC PROTEIN 2; FEMALE; HUMANS; INCIDENCE; LUMBAR VERTEBRAE; MALE; MIDDLE AGED; POSTOPERATIVE COMPLICATIONS; RECOMBINANT PROTEINS; RETROSPECTIVE STUDIES; SPINAL DISEASES; SPINAL FUSION; THORACIC VERTEBRAE;

EID: 84887256281     PISSN: 00219355     EISSN: 15351386     Source Type: Journal    
DOI: 10.2106/JBJS.L.01730     Document Type: Article

References (50)

1. O'Shaughnessy BA, Bridwell KH, Lenke LG, Cho W, Baldus C, Chang MS, Auerbach JD, Crawford CH. Does a long-fusion ''T3-sacrum'' portend a worse outcome than a short-fusion ''T10-sacrum'' in primary surgery for adult scoliosis? Spine (Phila Pa 1976) . 2012 May 1;37 (10) : 884-90.
2. Cho SK, Stoker GE, Bridwell KH. Spinal reconstruction with pedicle screw-based instrumentation and rhBMP-2 in patients with neurofibromatosis and severe dural ectasia and spinal deformity: report of two cases and a review of the literature. J Bone Joint Surg Am. 2011 Aug 3;93 (15) : e86.
3. Rahman RK, Bridwell KH, Lenke LG, Buchowski JM, Stephens B, Dorward IG, Koester L. Are TLIFs necessary for L5-S1 arthrodesis in long constructs to the sacrum/pelvis in primary adult spinal deformity patients? Spine: Afflilated Soc Meeting Abs. 2011: 68.
4. Good CR, Lenke LG, Bridwell KH, O'Leary PT, Pichelmann MA, Keeler KA, Baldus CR, Koester LA. Can posterior-only surgery provide similar radiographic and clinical results as combined anterior (thoracotomy/thoracoabdominal) /posterior approaches for adult scoliosis? Spine (Phila Pa 1976) . 2010 Jan 15;35 (2) : 210-8.
5. Maeda T, Buchowski JM, Kim YJ, Mishiro T, Bridwell KH. Long adult spinal deformity fusion to the sacrum using rhBMP-2 versus autogenous iliac crest bone graft. Spine (Phila Pa 1976) . 2009 Sep 15;34 (20) : 2205-12.
6. Mulconrey DS, Bridwell KH, Flynn J, Cronen GA, Rose PS. Bone morphogenetic protein (RhBMP-2) as a substitute for iliac crest bone graft in multilevel adult spinal deformity surgery: minimum two-year evaluation of fusion. Spine (Phila Pa 1976) . 2008 Sep 15;33 (20) : 2153-9.
7. Luhmann SJ, Bridwell KH, Cheng I, Imamura T, Lenke LG, Schootman M. Use of bone morphogenetic protein-2 for adult spinal deformity. Spine (Phila Pa 1976) . 2005 Sep 1;30 (17) (Suppl) : S110-7.
8. Crawford CH 3rd, Bridwell KH, Cho W, Buchowski JM, O'Shaughnessy BA, Chang MS, Auerbach JD. Extension of prior idiopathic scoliosis fusions to the sacrum: A matched cohort analysis of sixty patients with minimum two-year follow-up. Spine (Phila Pa 1976) . 2010 Sep 15;35 (20) : 1843-8.
9. Heavey S. Medtronic shares fall after U.S. rejects bone produce. Reuters. 2011 Mar 10. http://www.reuters.com/article/2011/03/10/us-medtronic- AmplifyidUSTRE7297TK20110310. Accessed 2012 Nov 4.
10. Dimar JR 2nd, Glassman SD, Burkus JK, Pryor PW, Hardacker JW, Carreon LY. Clinical and radiographic analysis of an optimized rhBMP-2 formulation as an autograft replacement in posterolateral lumbar spine arthrodesis. J Bone Joint Surg Am. 2009 Jun;91 (6) : 1377-86.
11. Food and Drug Administration. Executive summary for P050036 Medtronic's AMPLIFY rhBMP-2 matrix. 2010 Jul 27. http://www.fda.gov/downloads/ AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/ MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/ UCM220079.pdfǔtm-campaign=Google2&utm-source=fdaSearch&utm- medium=website&utm-term=P050036&utm-content=1. Accessed 2012 Jun 26.
12. Branch CL Jr. Physician-directed (off-label) use of recombinant bone morphogenic protein-2: let us do it well! Spine J. 2011 Jun;11 (6) : 469-70.
13. Carragee EJ, Mitsunaga KA, Hurwitz EL, Scuderi GJ. Retrograde ejaculation after anterior lumbar interbody fusion using rhBMP-2: A cohort controlled study. Spine J. 2011 Jun;11 (6) : 511-6. Epub 2011 May 25.
14. Carragee EJ, Hurwitz EL, Weiner BK. A critical review of recombinant human bone morphogenetic protein-2 trials in spinal surgery: emerging safety concerns and lessons learned. Spine J. 2011 Jun;11 (6) : 471-91.
15. Knox JB, Dai JM 3rd, Orchowski J. Osteolysis in transforaminal lumbar interbody fusion with bone morphogenetic protein-2. Spine (Phila Pa 1976) . 2011 Apr 15;36 (8) : 672-6.
16. Garrett MP, Kakarla UK, Porter RW, Sonntag VK. Formation of painful seroma and edema after the use of recombinant human bone morphogenetic protein-2 in posterolateral lumbar spine fusions. Neurosurgery. 2010 Jun;66 (6) : 1044-9, discussion: 1049.
17. McClellan JW, Mulconrey DS, Forbes RJ, Fullmer N. Vertebral bone resorption after transforaminal lumbar interbody fusion with bone morphogenetic protein (rhBMP-2) . J Spinal Disord Tech. 2006 Oct;19 (7) : 483-6.
18. Rihn JA, Patel R, Makda J, Hong J, Anderson DG, Vaccaro AR, Hilibrand AS, Albert TJ. Complications associated with single-level transforaminal lumbar interbody fusion. Spine J. 2009 Aug;9 (8) : 623-9. Epub 2009 May 30.
19. Brower RS, Vickroy NM. A case of psoas ossification from the use of BMP-2 for posterolateral fusion at L4-L5. Spine (Phila Pa 1976) . 2008 Aug 15;33 (18) : E653-5.
20. Muchow RD, Hsu WK, Anderson PA. Histopathologic inflammatory response induced by recombinant bone morphogenetic protein-2 causing radiculopathy after transforaminal lumbar interbody fusion. Spine J. 2010 Sep;10 (9) : e1-6.
21. Helgeson MD, Lehman RA Jr, Patzkowski JC, Dmitriev AE, Rosner MK, Mack AW. Adjacent vertebral body osteolysis with bone morphogenetic protein use in transforaminal lumbar interbody fusion. Spine J. 2011 Jun;11 (6) : 507-10.
22. Glassman SD, Hamill CL, Bridwell KH, Schwab FJ, Dimar JR, Lowe TG. The impact of perioperative complications on clinical outcome in adult deformity surgery. Spine (Phila Pa 1976) . 2007 Nov 15;32 (24) : 2764-70.
23. Berven S, Deviren V, Demir-Deviren S, Hu SS, Bradford DS. Studies in the modified Scoliosis Research Society Outcomes Instrument in adults: validation, reliability, and discriminatory capacity. Spine (Phila Pa 1976) . 2003 Sep 15;28 (18) : 2164-9, discussion: 2169.
24. Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976) . 2000 Nov 15;25 (22) : 2940-52, discussion: 2952.
25. Kim YW, Lenke LG, Kim YJ, Bridwell KH, Kim YB, Watanabe K, Watanabe K. Freehand pedicle screw placement during revision spinal surgery: Analysis of 552 screws. Spine (Phila Pa 1976) . 2008 May 1;33 (10) : 1141-8.
26. Okubadejo GO, Bridwell KH, Lenke LG, Buchowski JM, Fang DD, Baldus CR, Nielsen CH, Lee CC. Aprotinin may decrease blood loss in complex adult spinal deformity surgery, but it may also increase the risk of acute renal failure. Spine (Phila Pa 1976) . 2007 Sep 15;32 (20) : 2265-71.
27. Nielsen CH. Postoperative renal failure after aprotinin infusion and spine operations. Anesth Analg. 2006 Oct;103 (4) : 1062-3.
28. Ong KL, Villarraga ML, Lau E, Carreon LY, Kurtz SM, Glassman SD. Off-label use of bone morphogenetic proteins in the United States using administrative data. Spine (Phila Pa 1976) . 2010 Sep 1;35 (19) : 1794-800.
29. Cahill KS, Chi JH, Day A, Claus EB. Prevalence, complications, and hospital charges associated with use of bone-morphogenetic proteins in spinal fusion procedures. JAMA. 2009 Jul 1;302 (1) : 58-66.
30. Glassman SD, Howard J, Dimar J, Sweet A, Wilson G, Carreon L. Complications with recombinant human bone morphogenic protein-2 in posterolateral spine fusion: A consecutive series of 1037 cases. Spine (Phila Pa 1976) . 2011 Oct 15;36 (22) : 1849-54.
31. Zimmerman RM, Mohamed AS, Skolasky RL, Robinson MD, Kebaish KM. Functional outcomes and complications after primary spinal surgery for scoliosis in adults aged forty years or older: A prospective study with minimum two-year followup. Spine (Phila Pa 1976) . 2010 Sep 15;35 (20) : 1861-6.
32. Cho SK, Bridwell KH, Lenke LG, Yi JS, Pahys JM, Zebala LP, Kang MM, Cho W, Baldus CR. Major complications in revision adult deformity surgery: risk factors and clinical outcomes with 2-to 7-year follow-up. Spine (Phila Pa 1976) . 2012 Mar 15;37 (6) : 489-500.
33. Hassanzadeh H, Jain A, El Dafrawy MH, Neubauer PR, Mesfin A, Skolasky RL, Kebaish KM. Clinical results and functional outcome in adult patients following surgical treatment for spinal deformity: primary vs revision. Presented as a poster exhibit at the Annual Meeting of the American Academy of Orthopaedic Surgeons; 2012 Feb 7-11; San Francisco, CA. Poster no. 355.
34. Kim YJ, Bridwell KH, Lenke LG, Cho KJ, Edwards CC 2nd, Rinella AS. Pseudarthrosis in adult spinal deformity following multisegmental instrumentation and arthrodesis. J Bone Joint Surg Am. 2006 Apr;88 (4) : 721-8.
35. Molina CA, Sarabia-Estrada R, Gokaslan ZL, Witham TF, Bydon A, Wolinsky JP, Sciubba DM. Delayed onset of paralysis and slowed tumor growth following in situ placement of recombinant human bone morphogenetic protein 2 within spine tumors in a rat model of metastatic breast cancer. J Neurosurg Spine. 2012 Apr;16 (4) : 365-72. Epub 2012 Jan 20.
36. Hsu YL, Huang MS, Yang CJ, Hung JY, Wu LY, Kuo PL. Lung tumor-Associated osteoblast-derived bone morphogenetic protein-2 increased epithelial-to- mesenchymal transition of cancer by Runx2/Snail signaling pathway. J Biol Chem. 2011 Oct 28; 286 (43) : 37335-46. Epub 2011 Sep 01.
37. Hyzy SL, Olivares-Navarrete R, Schwartz Z, Boyan BD. BMP2 induces osteoblast apoptosis in a maturation state and noggin-dependent manner. J Cell Biochem. 2012 Oct;113 (10) : 3236-45.
38. Thawani JP, Wang AC, Than KD, Lin CY, La Marca F, Park P. Bone morphogenetic proteins and cancer: review of the literature. Neurosurgery. 2010 Feb;66 (2) : 233-46, discussion: 246.
39. Kang MH, Oh SC, Lee HJ, Kang HN, Kim JL, Kim JS, Yoo YA. Metastatic function of BMP-2 in gastric cancer cells: The role of PI3K/AKT, MAPK, the NF-kB pathway, and MMP-9 expression. Exp Cell Res. 2011 Jul 15;317 (12) : 1746-62. Epub 2011 Apr 30.
40. Gao Q, Tong W, Luria JS, Wang Z, Nussenbaum B, Krebsbach PH. Effects of bone morphogenetic protein-2 on proliferation and angiogenesis in oral squamous cell carcinoma. Int J Oral Maxillofac Surg. 2010 Mar;39 (3) : 266-71. Epub 2010 Jan 13.
41. SEER. SEER cancer statistics review 1975-2009. Table 2.21. http://seer.cancer.gov/csr/1975-2009-pops09/results-single/sect-02-table.21.pdf. Accessed 2013 Jun 30.
42. SEER. SEER cancer statistics review 1975-2009. Table 4.25. http://seer.cancer.gov/csr/1975-2009-pops09/results-single/sect-04-table.25.pdf. Accessed 2013 Jun 30.
43. SEER. SEER cancer statistics review 1975-2009. Table 11.21. http://seer.cancer.gov/csr/1975-2009-pops09/results-single/sect-11-table.21.pdf Accessed on 2013 Mar 1.
44. Sweetser S, Boardman LA. Cronkhite-Canada syndrome: An acquired condition of gastrointestinal polyposis and dermatologic abnormalities. Gastroenterol Hepatol (N Y) . 2012 Mar;8 (3) : 201-3.
45. Maruno T, Kikuyama M. Cronkhite-Canada syndrome associated with sigmoid colon cancer. Clin Gastroenterol Hepatol. 2011 Nov;9 (11) : e118-9. Epub 2011 Jun 13.
46. Sweetser S, Ahlquist DA, Osborn NK, Sanderson SO, Smyrk TC, Chari ST, Boardman LA. Clinicopathologic features and treatment outcomes in Cronkhite-Canada syndrome: support for autoimmunity. Dig Dis Sci. 2012 Feb;57 (2) : 496-502. Epub 2011 Sep 01.
47. Krishna YR, Ghoshal UC, Kumari N, Pandey R, Choudhuri G. Cronkhite-Canada syndrome with adenomatous polyposis. J Postgrad Med. 2008 Apr-Jun;54 (2) : 144-6.
48. Yashiro M, Kobayashi H, Kubo N, Nishiguchi Y, Wakasa K, Hirakawa K. Cronkhite-Canada syndrome containing colon cancer and serrated adenoma lesions. Digestion. 2004;69 (1) : 57-62. Epub 2004 Jan 30.
49. Mindea SA, Shih P, Song JK. Recombinant human bone morphogenetic protein-2-induced radiculitis in elective minimally invasive transforaminal lumbar interbody fusions: A series review. Spine (Phila Pa 1976) . 2009 Jun 15;34 (14) : 1480-4, discussion: 1485.
50. Lindley EM, McBeth ZL, Henry SE, Cooley R, Burger EL, Cain CM, Patel VV. Retrograde ejaculation following anterior lumbar spine surgery. Spine (Phila Pa 1976) . 2012 Sep15;37 (20) : 1785-9.