Complications with recombinant human bone morphogenic protein-2 in posterolateral spine fusion: A consecutive series of 1037 cases

Spine

Volumn 36, Issue 22, 2011, Pages 1849-1854

  Glassman, Steven D ^a,b,c   Howard, Jennifer ^b,c   Dimar, John ^a,b,c   Sweet, Alexander ^b   Wilson, Greg ^b   Carreon, Leah ^c  

^a Department of Orthopaedic Surgery ^*  (United States)

^b University of Louisville School of Medicine   (United States)

^c NORTON LEATHERMAN SPINE CENTER   (United States)

Author keywords

complications; posterolateral spine fusion; rhBMP 2

Indexed keywords

RECOMBINANT BONE MORPHOGENETIC PROTEIN 2;

ACUTE KIDNEY FAILURE; ADULT; AGED; ARTICLE; BONE GRAFT; BONE MATRIX; BONE SCREW; CASE STUDY; CLINICAL EVALUATION; COMPUTER ASSISTED TOMOGRAPHY; DRUG SAFETY; EPIDURAL HEMATOMA; FEMALE; HEART ARRHYTHMIA; HEART INFARCTION; HEART MUSCLE ISCHEMIA; HUMAN; ILEUS; ILIAC CREST; ILIOPSOAS HEMATOMA; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MALE; MEDICAL RECORD REVIEW; OPERATION DURATION; PERIOPERATIVE PERIOD; PNEUMONIA; POSTEROLATERAL SPINE FUSION; POSTOPERATIVE PERIOD; PRIORITY JOURNAL; RADICULOPATHY; RESPIRATORY FAILURE; RETROSPECTIVE STUDY; RISK BENEFIT ANALYSIS; SCOLIOSIS; SPINAL CORD ATROPHY; SPINE FUSION; SPINE INSTABILITY; SPONDYLOLISTHESIS; SURGICAL RISK; URINARY TRACT INFECTION; UROSEPSIS; WOUND INFECTION;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; BONE MORPHOGENETIC PROTEIN 2; BONE SUBSTITUTES; FEMALE; HUMANS; KENTUCKY; MALE; MIDDLE AGED; PATIENT SELECTION; POSTOPERATIVE COMPLICATIONS; RETROSPECTIVE STUDIES; RISK ASSESSMENT; SPINAL FUSION; SURGICAL SPONGES; TIME FACTORS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 80053962399     PISSN: 03622436     EISSN: 15281159     Source Type: Journal    
DOI: 10.1097/BRS.0b013e3181d133d0     Document Type: Article

References (48)

1. Dimar JR , Glassman SD , Burkus JK , et al. Clinical and radiographic analysis of an optimized rhBMP-2 formulation as an autograft replacement in posterolateral lumbar spine arthrodesis . J Bone Joint Surg In press.
2. Glassman SD , Carreon L , Djurasovic M , et al. Posterolateral lumbar spine fusion with INFUSE bone graft . Spine J 2007; 7:44-9. (Pubitemid 46002546)
3. Glassman SD , Carreon LY , Djurasovic M , et al. rhBMP-2 versus iliac crest bone graft for lumbar spine fusion: a randomized, controlled trial in patients over sixty years of age . Spine 2008; 33:2843-9.
4. Singh K , Smucker JD , Gill S , et al. Use of recombinant human bone morpho-genetic protein-2 as an adjunct in posterolateral lumbar spine fusion: a prospective CT-scan analysis at one and two years . J Spinal Disord Tech 2006; 19:416-23. (Pubitemid 44197593)
5. Vaccaro AR , Anderson DG , Patel T , et al. Comparison of OP-1 Putty (rhBMP-7) to iliac crest autograft for posterolateral lumbar arthrodesis: a minimum 2-year follow-up pilot study . Spine 2005; 30:2709-16. (Pubitemid 43011029)
6. Vaccaro AR , Lawrence JP , Patel T , et al. The safety and effi cacy of OP-1 (rhBMP-7) as a replacement for iliac crest autograft in posterolateral lumbar arthrodesis: a long-term ( > 4 years) pivotal study . Spine 2008; 33:2850-62.
7. Boden SD , Kang J , Sandhu H , et al. Use of recombinant human bone mor-phogenetic protein-2 to achieve posterolateral lumbar spine fusion in humans: a prospective, randomized clinical pilot trial: 2002 Volvo Award in clinical studies . Spine 2002; 27:2662-73. (Pubitemid 35425320)
8. Dawson E , Bae HW , Burkus JK , et al. Use of rhBMP-2 on an absorbable collagen sponge combined with an osteoconductive bulking agent in instrumented posterolateral arthrodesis: a prospective, randomized trial . J Bone Joint Surg In press.
9. Shields LB , Raque GH , Glassman SD , et al. Adverse effects associated with high-dose recombinant human bone morphogenetic protein-2 use in anterior cervical spine fusion . Spine 2006; 31:542-7.
10. Smucker JD , Rhee JM , Singh K , et al. Increased swelling complications associated with off-label usage of rhBMP-2 in the anterior cervical spine . Spine 2006; 31:2813-9. (Pubitemid 44772783)
11. Buttermann GR . Prospective nonrandomized comparison of an allograft with bone morphogenic protein versus an iliac-crest autograft in anterior cervical discectomy and fusion . Spine J 2008; 8:426-35.
12. Vaidya R , Carp J , Sethi A , et al. Complications of anterior cervical discec-tomy and fusion using recombinant human bone morphogenetic protein-2 . Eur Spine J 2007; 16:1257-65. (Pubitemid 350104617)
13. Wong DA , Kumar A , Jatana S , et al. Neurologic impairment from ectopic bone in the lumbar canal: a potential complication of offlabel PLIF/TLIF use of bone morphogenetic protein-2 (BMP-2) . Spine J 2008; 8:1011-8.
14. Villavicencio AT , Burneikiene S , Nelson EL , et al. Safety of transforaminal lumbar interbody fusion and intervertebral recombinant human bone morphogenetic protein-2 . J Neurosurg Spine 2005; 3:436-43.
15. Lewandrowski KU , Nanson C , Calderon R . Vertebral osteolysis after posterior interbody lumbar fusion with recombinant human bone morphogenetic protein 2: a report of fi ve cases . Spine J 2007; 7:609-14. (Pubitemid 47471438)
16. FDA Public Health Notifi cation . Life-threatening complications associated with recombinant human bone morphogenetic protein in cervical spine fusion . Issued July 1, 2008 . Available at: http://www.fda.gov/cdrh/safety/ 070108-rhBMP.html. Accessed September 10, 2008.
17. Isaza JE , Guillory SA , Wilks SE . A descriptive analysis of reactions with the use of BMP in Posterior Interbody Fusions . In: Proceedings of International Meeting on Advanced Spine Techniques . Hong Kong, China . July 8-11: 85.
18. Brower RS , Vickroy NM . A case of psoas ossifi cation from the use of BMP-2 for posterolateral fusion at L4-L5 . Spine 2008; 33:E653-5.
19. Luhmann SJ , Bridwell KH , Cheng I , et al. Use of bone morphogenetic protein-2 for adult spinal deformity . Spine 2005; 30 ( suppl 17 ): S110-7. (Pubitemid 41292212)
20. Maeda T , Buchowski JM , Kim YJ , et al. Long adult spinal deformity fusion to the sacrum using rhBMP-2 versus autogenous iliac crest bone graft . Spine 2009; 34:2205-12.
21. Mulconrey DS , Bridwell KH , Flynn J , et al. Bone morphogenetic protein (rhBMP-2) as a substitute for iliac crest bone graft in multilevel adult spinal deformity surgery: minimum 2-year evaluation of fusion . Spine 2008 ;33: 2153-9.
22. Carreon LY , Puno RM , Dimar JR , et al. Perioperative complications of posterior lumbar decompression and arthrodesis in older adults . J Bone Joint Surg Am 2003; 85:2089-92. (Pubitemid 37385904)
23. Cho K , Suk S , Park S , et al. Complications in posterior fusion and instrumentation for degenerative lumbar scoliosis . Spine 2007; 32:2232-7. (Pubitemid 47415106)
24. Deyo RA , Cherkin DC , Loeser JD , et al. Morbidity and mortality in association with operations on the lumbar spine . J Bone Joint Surg Am 1992 ;74: 536-43.
25. Kuntz KM , Snider RK , Weinstein JN , et al. Cost-effectiveness of fusion with and without instrumentation for patients with degenerative spondylolisthesis and spinal stenosis . Spine 2000; 25:1132-9. (Pubitemid 30317196)
26. Fritzell P , Hagg O , Wessberg P , et al. Chronic low back pain and fusion: a comparison of three surgical techniques . Spine 2002; 27:1131-41.
27. Brown CA , Eismont FJ . Complications in spinal fusion . Orthop Clin North Am 1998; 29:679-99. (Pubitemid 28501132)
28. Capen DA , Calderone RR , Green A . Perioperative risk factors for wound infections after lower back fusions . Orthop Clin North Am 1996; 27:83-6. (Pubitemid 26020214)
29. Collins I , Wilson-MacDonald J , Chami G , et al. The diagnosis and management of infection following instrumented spinal fusion . Eur Spine J 2008; 17:445-50.
30. Davne SH , Myers DL . Complications of lumbar spinal fusion with transpe-dicular instrumentation . Spine 1992; 17 ( suppl 6 ): S184-9.
31. Gepstein R , Eismont FJ . Postoperative spine infections . In: Garfin SR , ed. Complications of Spine Surgery . Baltimore, MD:Williams & Wilkins; 1989:302-22.
32. Glassman SD , Alegre G , Carreon L , et al. Perioperative complications in patients with diabetes mellitus treated by lumbar instrumentation and fusion . Spine J 2003; 3:496-501. (Pubitemid 37337237)
33. Levi AD , Dickman CA , Sonntag VK . Management of postoperative infections after spinal instrumentation . J Neurosurg 1997; 86:975-80. (Pubitemid 27230140)
34. Ross AC . Infections complicating joint replacement and other orthopaedic conditions . Curr Opin Rheumatol 1993; 5:461-7. (Pubitemid 23219399)
35. Matsuzaki H , Tokuhashi Y , Matsumato F , et al. Problems and solutions of pedicle screw plate fi xation of lumbar spine . Spine 1990; 15:1159-65.
36. Pihlajamaki H , Myllynen P , Bostman O . Complications of transpedicular lumbosacral fi xation for non-traumatic disorders . J Bone Joint Surg Br 1997; 79:183-9.
37. West JL , Ogilvie JW , Bradford DS . Complications of the variable screw plate pedicle screw fi xation . Spine 1991; 16:576-9.
38. Awad JN , Kebaish KM , Donigan J , et al. Analysis of the risk factors for the development of post-operative spinal epidural hematoma . J Bone Joint Surg Br 2005; 87:1248-52. (Pubitemid 41387566)
39. Kebaish KM , Awad JN . Spinal epidural hematoma causing acute cauda equina syndrome [review] . Neurosurg Focus 2004; 16:e1.
40. Kou J , Fischgrund J , Biddinger A , et al. Risk factors for spinal epidural hematoma after spinal surgery . Spine 2002; 27:1670-3. (Pubitemid 34839653)
41. Sokolowski MJ , Garvey TA , Perl J II , et al. Prospective study of postoperative lumbar epidural hematoma: incidence and risk factors . Spine 2008; 33:108-13.
42. Eismont FJ , Wiesel SW , Rothman RH . Treatment of dural tears associated with spinal surgery . J Bone Joint Surg Am 1981; 63:1132-6. (Pubitemid 11015791)
43. Finnegan WJ , Fenlin JM , Marvel JP , et al. Results of surgical intervention in the symptomatic multiply-operated back patient: analysis of sixty-seven cases followed by 3 to 7 years . J Bone Joint Surg Am 1979; 61:1077-82. (Pubitemid 10250153)
44. Jones AA , Stambough JL , Balderston RA , et al. Long-term results of lumbar spine surgery complicated by unintended incidental durotomy . Spine 1989; 14:443-6. (Pubitemid 19129733)
45. Kitchel SH , Eismont FJ , Green BA . Closed subarachnoid drainage for management of cerebrospinal fl uid leakage after an operation on the spine . J Bone Joint Surg Am 1989; 71:984-7. (Pubitemid 19215055)
46. Robinson DE , Ball KE , Webb PJ . Iliopsoas hematoma with femoral neuropathy presenting a diagnostic dilemma after spinal decompression . Spine 2001; 26:E135-8.
47. Kim SW , Choi JH . Myositis ossifi cans in psoas muscle after lumbar spine fracture . Spine 2009; 34:E367-70.
48. Glassman SD , Howard JM , Sweet RA , et al. Complications and concerns with osteobiologics for spine fusion in clinical practice . Spine In press.