Retrograde ejaculation after anterior lumbar interbody fusion with and without bone morphogenetic protein-2 augmentation: A 10-year cohort controlled study

Spine Journal

Volumn 12, Issue 10, 2012, Pages 881-890

  Comer, Garet C ^a   Smith, Micah W ^a   Hurwitz, Eric L ^b   Mitsunaga, Kyle A ^a   Kessler, Robert ^c   Carragee, Eugene J ^a  

^a STANFORD UNIVERSITY MEDICAL CENTER   (United States)

^b UNIVERSITY OF HAWAII   (United States)

^c STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Anterior lumbar interbody fusion; Growth factor rhBMP 2; Retrograde ejaculation

Indexed keywords

RECOMBINANT BONE MORPHOGENETIC PROTEIN 2;

ADULT; AGED; ANTERIOR SPINE FUSION; ARTICLE; CONTROLLED STUDY; DRUG EXPOSURE; DRUG USE; HUMAN; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; PROSTATE HYPERTROPHY; RETROGRADE EJACULATION; RETROSPECTIVE STUDY; SPONDYLOLISTHESIS; SPONDYLOSIS; URINARY CATHETER; URINE RETENTION;

ADULT; AGED; BONE MORPHOGENETIC PROTEIN 2; EJACULATION; HUMANS; LUMBAR VERTEBRAE; MALE; MIDDLE AGED; POSTOPERATIVE COMPLICATIONS; RECOMBINANT PROTEINS; RETROSPECTIVE STUDIES; SEXUAL DYSFUNCTION, PHYSIOLOGICAL; SPINAL FUSION; SPONDYLOLISTHESIS; SPONDYLOSIS; TRANSFORMING GROWTH FACTOR BETA; YOUNG ADULT;

EID: 84870302952     PISSN: 15299430     EISSN: 18781632     Source Type: Journal    
DOI: 10.1016/j.spinee.2012.09.040     Document Type: Article

References (46)

1. S. Bhasin, and R. Basson Sexual dysfunction in men and woman H.M. Kronenberg, S. Melmed, K.S. Polonsky, P.R. Larsen, Williams textbook of endocrinology 12th ed 2011 Saunders Elsevier Philadelphia, PA
2. L. Lipshultz, A. Thomas, and M. Khera Surgical management of male infertility Campbell-Walsh Urology 9th edition 2007 Saunders Elsevier Philadelphia, PA
3. E.J. Carragee, K.A. Mitsunaga, E.L. Hurwitz, and G.J. Scuderi Retrograde ejaculation after anterior lumbar interbody fusion using rhBMP-2: a cohort controlled study Spine J 11 2011 511 516
4. M.G. Kaiser, R.W. Haid Jr., B.R. Subach, and J.S. Miller Comparison of the mini-open versus laparoscopic approach for anterior lumbar interbody fusion: a retrospective review Neurosurgery 51 2002 97 103 discussion 103-105
5. C.D. Jarrett, J.G. Heller, and L. Tsai Anterior exposure of the lumbar spine with and without an 'access surgeon': morbidity analysis of 265 consecutive cases J Spinal Disord Tech 22 2009 559 564
6. J.J. Fenton, S.K. Mirza, and A. Lahad Variation in reported safety of lumbar interbody fusion Spine 32 2007 471 480
7. B.-U. Kang, W.C. Choi, S.H. Lee, and S.H. Jeon An analysis of general surgery-related complications in a series of 412 minilaparotomic anterior lumbosacral procedures J Neurosurg Spine 10 2009 60 65
8. E.M. Lindley, Z.L. McBeth, S.E. Henry, and R. Cooley Retrograde ejaculation after anterior lumbar spine surgery Spine 37 2012 1785 1789
9. E.J. Carragee, E.L. Hurwitz, and B.K. Weiner Authors and editors combined response to Zdeblick letter Spine J 11 2011 687 690
10. T.A. Zdeblick Science please Spine J 11 2011 686
11. D.M. Spengler Commentary: resetting standards for sponsored research: do conflicts influence results? Spine J 11 2011 492 494
12. P. Aspenberg Under-reported complications related to BMP use in spine surgery Acta Orthop 82 2011 511 512
13. S.K. Mirza Commentary: folly of FDA-approval studies for bone morphogenetic protein Spine J 11 2011 495 499
14. M.D. Helgeson, R.A. Lehman, and J. Patzkowski Adjacent vertebral body osteolysis with bone morphogenetic protein use in transforaminal lumbar interbody fusion Spine J 11 2011 507 510
15. United States Food and Drug Administration, Department of Health and Human Services, Center for Devices and Radiological Health. InFUSE Bone Graft/LT-CAGE? Lumbar Tapered Fusion Devices - P000058. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm? num5P000058. Accessed July 2, 2002.
16. J.K. Burkus, S.E. Heim, M.F. Gornet, and T.A. Zdeblick Is INFUSE bone graft superior to autograft bone? An integrated analysis of clinical trials using the LT-CAGE lumbar tapered fusion device J Spinal Disord Tech 16 2003 113 122
17. E.J. Carragee, E.L. Hurwitz, and B.K. Weiner A critical review of recombinant human bone morphogenetic protein-2 trials in spinal surgery: emerging safety concerns and lessons learned Spine J 11 2011 471 491
18. K.L. Ong, M.L. Villarraga, E. Lau, and L.Y. Carreon Off-label use of bone morphogenetic proteins in the United States using administrative data Spine 35 2010 1794 1800
19. E.J. Carragee, A.J. Ghanayem, and B.K. Weiner A challenge to integrity in spine publications: years of living dangerously with the promotion of bone growth factors Spine J 11 2011 463 468
20. E.J. Carragee, C.M. Bono, and G.J. Scuderi Pseudomorbidity in iliac crest bone graft harvesting: the rise of rhBMP-2 in short-segment posterior lumbar fusion Spine J 9 2009 873 879
21. Center for Devices and Radiological Health. Public Health Notifications (Medical Devices) - FDA Public Health Notification: life-threatening complications associated with recombinant human bone morphogenetic protein in cervical spine fusion. Available at: http://www.fda.gov/MedicalDevices/Safety/ AlertsandNotices/PublicHealthNotifications/ucm062000.htm. Accessed October 4, 2012.
22. Food and Drug Administration Public Meeting Orthopedic and Rehabiliation Devices Advisory Panel. (2002). Available at: www.fda.gov/ohrms/dockets/ac/02/ transcripts/3828t1.doc. Accessed October 4, 2012.
23. P. Klimo Jr., and M.W. Peelle Use of polyetheretherketone spacer and recombinant human bone morphogenetic protein-2 in the cervical spine: a radiographic analysis Spine J 9 2009 959 966
24. J.B. Knox, J.M. Dai, and J. Orchowski Osteolysis in transforaminal lumbar interbody fusion with bone morphogenetic protein-2 Spine 36 2011 672 676
25. R.J. Mannion, A.M. Nowitzke, and M.J. Wood Promoting fusion in minimally invasive lumbar interbody stabilization with low-dose bone morphogenic protein-2 - but what is the cost? Spine J 11 2011 527 533
26. T.E. Mroz, J.C. Wang, R. Hashimoto, and D.C. Norvell Complications related to osteobiologics use in spine surgery: a systematic review Spine 35 2010 S86 S104
27. B. Perri, M. Cooper, C. Lauryssen, and N. Anand Adverse swelling associated with use of rh-BMP-2 in anterior cervical discectomy and fusion: a case study Spine J 7 2007 235 239
28. J.A. Rihn, R. Patel, J. Makda, and J. Hong Complications associated with single-level transforaminal lumbar interbody fusion Spine J 9 2009 623 629
29. T. Smoljanovic, and M. Pecina Re: Burkus JK, Sandhu HS, Gornet MF. Influence of rhBMP-2 on the healing patterns associated with allograft interbody constructs in comparison with autograft. Spine 2006;31:775-81 Spine 33 2008 226
30. T. Smoljanovic, F. Siric, and I. Bojanic Six-year outcomes of anterior lumbar interbody arthrodesis with use of interbody fusion cages and recombinant human bone morphogenetic protein-2 J Bone Joint Surg Am 92 2010 2614 2615 author reply 2615-2616
31. J.D. Smucker, J.M. Rhee, and K. Singh Increased swelling complications associated with off-label usage of rhBMP-2 in the anterior cervical spine Spine 31 2006 2813 2819
32. L.M. Tumialán, and G.E. Rodts Adverse swelling associated with use of rh-BMP-2 in anterior cervical discectomy and fusion Spine J 7 2007 509 510
33. R. Vaidya, R. Weir, A. Sethi, and S. Meisterling Interbody fusion with allograft and rhBMP-2 leads to consistent fusion but early subsidence J Bone Joint Surg Br 89 2007 342 345
34. B.J. Williams, J.S. Smith, K.M. Fu, and D.K. Hamilton Complications associated with BMP use in 11,933 cases of spinal fusion Spine J 10 2010 S98 S99
35. D.A. Wong, A. Kumar, and S. Jatana Neurologic impairment from ectopic bone in the lumbar canal: a potential complication of off-label PLIF/TLIF use of bone morphogenetic protein-2 (BMP-2) Spine J 8 2008 1011 1018
36. J.K. Burkus, M.F. Gornet, and T.C. Schuler RE: Six-year outcomes of anterior lumbar interbody arthrodesis with use of interbody fusion cages and recombinant human bone morphogenetic protein-2 J Bone Joint Surg Am 92 2010 2615 2616 Letter
37. J.D. Kang Commentary: another complication associated with rhBMP-2? Spine J 11 2011 517 519
38. H.A. Matthews, M.F. Gornet, J.K. Burkus, R.F. Dryer, and J.H. Peloza Lumbar disc arthroplasty with MAVERICK disc versus stand-alone interbody fusion: a prospective, randomized, controlled, multicenter investigational device exemption trial Spine 36 2011 E1600 E1611
39. J.K. Burkus, M.F. Gornet, C.A. Dickman, and T.A. Zdeblick Anterior lumbar interbody fusion using rhBMP-2 with tapered interbody cages J Spinal Disord Tech 15 2002 337 349
40. J.P.A. Ioannidis, S.J. Evans, P.C. Gtzsche, and R.T. O'Neill Better reporting of harms in randomized trials: an extension of the CONSORT statement Ann. Intern. Med 141 2004 781 788
41. A.R. Poynton, and J.M. Lane Safety profile for the clinical use of bone morphogenetic proteins in the spine Spine 27 2002 S40 S48
42. N.E. Epstein Pros, cons, and costs of INFUSE in spinal surgery Surg Neurol Int 2 2011 10
43. R.C. Sasso, J. Kenneth Burkus, and J.-C. LeHuec Retrograde ejaculation after anterior lumbar interbody fusion: transperitoneal versus retroperitoneal exposure Spine 28 2003 1023 1026
44. T. Smoljanovic, I. Bojanic, and M. Rakovac Re: Sasso RC, Burkus JK, LeHuec JC. Retrograde ejaculation after anterior lumbar interbody fusion: transperitoneal versus retroperitoneal exposure. Spine 2003;28:1023-6 Spine 35 2010 E622 author reply E623
45. R.C. Sasso, S.H. Kitchel, and E.G. Dawson A prospective, randomized controlled clinical trial of anterior lumbar interbody fusion using a titanium cylindrical threaded fusion device Spine 29 2004 113 122 discussion 121-122
46. FDA INTER FIX™ Threaded Fusion Device - P970015. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=p. 970015. Accessed October 4, 2012.