Clinical and radiological evaluation of Trabecular Metal and the Smith-Robinson technique in anterior cervical fusion for degenerative disease: A prospective, randomized, controlled study with 2-year follow-up

European Spine Journal

Volumn 19, Issue 3, 2010, Pages 464-473

  Löfgren, Håkan ^a   Engquist, M ^a   Hoffmann, P ^a   Sigstedt, B ^a   Vavruch, L ^a  

^a RYHOV COUNTY HOSPITAL   (Sweden)

Author keywords

Cervical vertebrae; Randomized controlled trial; Spinal fusion; Tantalum; Trabecular Metal

Indexed keywords

TANTALUM;

ADULT; AGED; ANTERIOR CERVICAL DECOMPRESSION AND FUSION; ARTICLE; BONE CONDUCTION; BONE GRAFT; CERVICAL SPINE; CERVICAL SPONDYLOSIS; CERVICOBRACHIAL NEURALGIA; CLINICAL EVALUATION; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; FEMALE; FOLLOW UP; HIP PAIN; HUMAN; ILIAC CREST; IMPLANT; INTERMETHOD COMPARISON; INTERVERTEBRAL DISK DEGENERATION; INTERVERTEBRAL DISK HERNIA; INTERVERTEBRAL DISKECTOMY; MAJOR CLINICAL STUDY; MALE; NECK PAIN; NUCLEAR MAGNETIC RESONANCE IMAGING; OPERATION DURATION; PAIN ASSESSMENT; POSTOPERATIVE COMPLICATION; POSTOPERATIVE PERIOD; PREOPERATIVE PERIOD; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SMITH ROBINSON TECHNIQUE; SPINE FUSION; SURGICAL TECHNIQUE; TRABECULAR BONE; VISUAL ANALOG SCALE;

ADULT; AGED; CERVICAL VERTEBRAE; CHI-SQUARE DISTRIBUTION; DECOMPRESSION, SURGICAL; FEMALE; FOLLOW-UP STUDIES; HUMANS; INTERVERTEBRAL DISK DEGENERATION; MALE; MIDDLE AGED; PAIN MEASUREMENT; PATIENT SATISFACTION; PATIENT SELECTION; PROSPECTIVE STUDIES; RECOVERY OF FUNCTION; SEVERITY OF ILLNESS INDEX; SPINAL FUSION; TREATMENT OUTCOME;

EID: 77951104206     PISSN: 09406719     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00586-009-1161-z     Document Type: Article

References (54)

1. JC Banwart MA Asher RS Hassanein 1995 Iliac crest bone graft harvest donor site morbidity: a statistical evaluation Spine 20 1055 1060 10.1097/00007632-199505000-00012 1:STN:280:DyaK2MzlslOhsA%3D%3D 7631235
2. SA Barbour W King 2003 Basic science update: the safe and effective use of allograft tissue, an update Am J Sports Med 31 791 797 12975205
3. Baskin DS, Traynelis V (2004) Failure of porous tantalum cervical interbody fusion devices: two-year results from a prospective, randomized, multi-center, clinical study. Annual Meeting, Cervical Spine Research Society, Boston, USA
4. JD Bobyn GJ Stackpool SA Hacking M Tanzer JJ Krygier 1999 Characteristics of bone ingrowth and interface mechanics of a new porous tantalum biomaterial J Bone Joint Surg (Br) 81-B 907 914 10.1302/0301-620X.81B5.9283 (Pubitemid 29438375)
5. Boden SD, Schimandle JH (1996) Fusion: biology of lumbar spine fusion and bone graft materials. In: International Society for Study of the Lumbar Spine Editorial Committee, editors. The lumbar spine, 2nd edn, Saunders, Philadelphia, pp 1284-1306
6. MN Bucci D Philyaw 1998 Successful fusion using allogeneic bone graft in anterior cervical discectomy and fusion J S C Med Assoc 94 9 11 1:STN:280:DyaK1c7jsVWgtg%3D%3D 9473865
7. BE Buck TI Malinen MD Brown 1989 Bone transplantation and the human immunodeficiency virus: an estimate of the risk of acquired immunodeficiency syndrome (AIDS) Clin Orthop Relat Res 240 129 136 2645073
8. LK Cannada SC Scherping JU Yoo PK Jones SE Emery 2003 Pseudoarthrosis of the cervical spine: a comparison of radiographic diagnostic measures Spine 28 46 51 10.1097/00007632-200301010-00012 12544955 (Pubitemid 36070772)
9. JC Cauthen RE Kinard JB Vogler DE Jackson OB DePaz OL Hunter, et al.. 1998 Outcome analysis of noninstrumented anterior cervical discectomy and interbody fusion in 348 patients Spine 23 188 192 10.1097/00007632-199801150- 00008 1:STN:280:DyaK1c7jsFSltw%3D%3D 9474724 (Pubitemid 28128152)
10. RB Cloward 1958 The anterior approach for ruptured cervical discs J Neurosurg 15 602 614 10.3171/jns.1958.15.6.0602 1:STN:280:DyaG1M%2FivVCmtg%3D%3D 13599052
11. R Cohen 2002 A porous tantalum Trabecular Metal: basic science Am J Orthop 31 216 217 12008853
12. AF DePalma RH Rothman GE Lewinnek ST Canale 1972 Anterior interbody fusion for severe cervical disc degeneration Surg Gynecol Obstet 134 755 758 1:STN:280:DyaE383gtFOksg%3D%3D 5031486
13. DR Fassett RI Apfelbaum JA Hipp 2008 Comparison of fusion assessment techniques: computer-assisted versus manual measurements J Neurosurg Spine 8 544 547 10.3171/SPI/2008/8/6/544 18518675 (Pubitemid 351830240)
14. M Fernández-Fairen P Sala M Dufoo Jr J Ballester A Murcia L Merzthal 2008 Anterior cervical fusion with tantalum implant: a prospective randomized controlled study Spine 33 465 472 10.1097/BRS.0b013e3181657f49 18317188 (Pubitemid 351644448)
15. S Fujibayashi M Neo T Nakamura 2008 Stand-alone interbody cage versus anterior cervical plate for treatment of cervical disc herniation: sequential changes in cage subsidence J Clin Neurosci 15 1017 1022 10.1016/j.jocn.2007.05. 011 18653347
16. AR Gazdag JM Lane D Glaser RA Fortster 1995 Alternatives to autologous bone graft. Efficacy and indications J Am Acad Orthop Surg 3 1 8 10790647
17. J Kärrholm 1989 Roentgen stereophotogrammetry: review of orthopaedic applications Acta Orthop Scand 60 491 503 2683567
18. DJ Kelly M Ahmad SJ Brull 2001 Preemptive analgesia. I. Physiological pathways and pharmacological modalities Can J Anaesth 48 1000 1010 10.1007/BF03016591 1:STN:280:DC%2BD3MnksFOlug%3D%3D 11698320
19. P Lavand'homme 2006 Perioperative pain Curr Opin Anaesthesiol 19 556 561 10.1097/01.aco.0000245284.53152.1f 16960491 (Pubitemid 44386061)
20. G Leivseth F Kolstad OP Nygaard B Zoëga W Frobin P Brinckmann 2006 Comparing precision of distortion-compensated and stereophotogrammetric Roentgen analysis when monitoring fusion in the cervical spine Eur Spine J 15 774 779 10.1007/s00586-005-0929-z 16163513 (Pubitemid 43873765)
21. AD Levi WG Choi PJ Keller JE Heiserman VK Sonntag CA Dickman 1998 The radiographic and imaging characteristics of porous tantalum implants within the human cervical spine Spine 23 1245 1251 10.1097/00007632-199806010-00014 1:STN:280:DyaK1czgtVKjtQ%3D%3D 9636978 (Pubitemid 28285057)
22. BR Levine S Sporer RA Poggie CJ Della Valle JJ Jacobs 2006 Experimental and clinical performance of porous tantalum in orthopedic surgery Biomaterials 27 4671 4681 10.1016/j.biomaterials.2006.04.041 1:CAS:528:DC%2BD28XlsFCrt78%3D 16737737 (Pubitemid 43849977)
23. BI Lind B Zoëga H Rosen 2007 Autograft versus interbody fusion cage without plate fixation in the cervical spine: a randomized clinical study using radiostereometry Eur Spine J 16 1251 1256 10.1007/s00586-007-0337-7 17342510 (Pubitemid 350104613)
24. H Löfgren J Vallö Christiansen V Johannsson B Levander 1999 MRI and clinical course after anterior cervical decompression and fusion: a prospective two-year longitudinal evaluation showing fibrous union of the bovine graft Neuro-Orthopedics 26 19 31
25. H Löfgren V Johannsson T Olsson L Ryd B Levander 2000 Rigid fusion after Cloward operation for cervical disc disease using autograft, allograft, or xenograft: a randomized study with radiostereometric and clinical follow-up assessment Spine 25 1908 1916 10.1097/00007632-200008010-00008 10908933 (Pubitemid 30626069)
26. TE Mroz MJ Joyce MP Steinmetz IH Lieberman JC Wang 2008 Musculoskeletal allograft risks and recalls in the United States J Am Acad Orthop Surg 16 559 565 18832599
27. A Peolsson L Vavruch R Hedlund 2007 Long-term randomised comparison between a carbon fibre cage and the Cloward procedure in the cervical spine Eur Spine J 16 173 178 10.1007/s00586-006-0067-2 16463197 (Pubitemid 46295199)
28. R Pollock I Alcelik C Bhatia G Chuter K Lingutla C Budithi M Krishna 2008 Donor site morbidity following iliac crest bone harvesting for cervical fusion: a comparison between minimally invasive and open techniques Eur Spine J 17 845 852 10.1007/s00586-008-0648-3 18389294
29. L Ryd X Yuan H Löfgren 2000 Methods for determining the accuracy of radiostereometric analysis (RSA) Acta Orthop Scand 71 403 408 1:STN:280:DC%2BD3cvnslGhsw%3D%3D 11028891
30. SI Ryu M Mitchell DH Kim 2006 A prospective randomized study comparing a cervical carbon fiber cage to the Smith-Robinson technique with allograft and plating: up to 24 months follow-up Eur Spine J 15 157 164 10.1007/s00586-005- 0951-1 15980998
31. D Samartzis FH Shen C Lyon M Phillips EJ Goldberg HS An 2004 Does rigid instrumentation increase the fusion rate in one-level anterior cervical discectomy and fusion? Spine J 4 636 643 10.1016/j.spinee.2004.04.010 15541695 (Pubitemid 39497283)
32. P Sampath M Bendebba JD Davis T Ducker 1999 Outcome in patients with cervical radiculopathy: prospective, multicenter study with independent clinical review Spine 24 591 597 10.1097/00007632-199903150-00021 1:STN:280: DyaK1M3gt1Smtw%3D%3D 10101827 (Pubitemid 29136055)
33. S Savolainen JP Usenius J Hernesniemi 1994 Iliac crest versus artificial bone grafts in 250 cervical fusions Acta Neurochir (Wien) 129 54 57 10.1007/BF01400873 1:STN:280:DyaK2M%2FptFWgtQ%3D%3D (Pubitemid 24225620)
34. CL Schnee A Freese RJ Weil PJ Marcotte 1997 Analysis of harvest morbidity and radiographic outcome using autograft for anterior cervical fusion Spine 22 2222 2226 10.1097/00007632-199710010-00005 1:STN:280:DyaK1c%2FgsVWhug%3D%3D 9346142 (Pubitemid 28074052)
35. TM) device for cervical interbody fusion: results from a prospective, randomized multi-centre clinical trial. Annual Meeting, Cervical Spine Research Society, San Diego, USA
36. N Shimamoto BW Cunningham AE Dmitriev A Minami PC McAfee 2001 Biomechanical evaluation of stand-alone interbody fusion cages in the cervical spine Spine 26 E432 E436 10.1097/00007632-200110010-00008 1:STN:280: DC%2BD3MnnsFGhtA%3D%3D 11698902
37. JS Silber DG Anderson SD Daffner BT Brislin JM Leland AS Hilibrand AR Vaccaro TA Albert 2003 Donor site morbidity after anterior iliac crest bone harvest for single-level anterior cervical discectomy and fusion Spine 28 134 139 10.1097/00007632-200301150-00008 12544929 (Pubitemid 36110079)
38. K Singh D Samartzis J Strom D Manning M Campbell-Hupp FT Wetzel P Gupta FM Phillips 2005 A prospective, randomized, double-blind study evaluating the efficacy of postoperative continuous local anesthetic infusion at the iliac crest bone graft site after spinal arthrodesis Spine 30 2477 2483 10.1097/01.brs.0000186323.11285.b1 16284583 (Pubitemid 41669081)
39. K Singh FM Phillips E Kuo M Campbell 2007 A prospective, randomized, double-blind study of the efficacy of postoperative continuous local anesthetic infusion at the iliac crest bone graft site after posterior spinal arthrodesis: a minimum of 4-year follow-up Spine 32 2790 2796 10.1097/BRS.0b013e31815b7650 18245999 (Pubitemid 351339347)
40. GW Smith RA Robinson 1958 The treatment of certain cervical-spine disorders by anterior removal of the intervertebral disc and interbody fusion J Bone Joint Surg (Am) 41A 607 624
41. E Svensson 1998 Ordinal invariant measures for individual and group changes in ordered categorical data Stat Med 17 2923 2936 10.1002/(SICI)1097- 0258(19981230)17:24<2923::AID-SIM104>3.0.CO;2-# 1:STN:280: DyaK1M7itVWkug%3D%3D 9921610 (Pubitemid 28562984)
42. E Svensson 2001 Guidelines to statistical evaluation of data from ratings scales and questionnaires J Rehabil Med 33 47 48 10.1080/165019701300006542 1:STN:280:DC%2BD38%2FisVKjsg%3D%3D 11480471 (Pubitemid 32401161)
43. AR Vaccaro K Chiba JG Heller Patel TCh JS Thalgott E Truumees JS Fischgrund MR Craig SC Berta JC Wang North American Spine Society for Contemporary Concepts in Spine Care 2002 Bone grafting alternatives in spinal surgery Spine J 2 206 215 10.1016/S1529-9430(02)00180-8 14589495
44. J Van Limbeek WCH Jacobs PG Anderson PW Pavlov 2000 A systematic literature review to identify the best method for a single-level anterior cervical interbody fusion Eur Spine J 9 129 136 10.1007/s005860050223 10823429
45. L Vavruch R Hedlund D Javid W Leszniewski A Shalabi 2002 A prospective randomized comparison between the Cloward procedure and a carbon fiber cage in the cervical spine: a clinical and radiologic study Spine 27 1694 1701 10.1097/00007632-200208150-00003 12195057
46. H Vernon S Mior 1991 The Neck Disability Index: a study of reliability and validity J Manipulative Physiol Ther 14 409 415 1:STN:280: DyaK38%2FksVWlsg%3D%3D 1834753
47. JC Wang WD Yu HS Sandhu V Tam RB Delamarter 1998 A comparison of magnetic resonance and computed tomographic image quality after the implantation of tantalum and titanium instrumentation Spine 23 1684 1688 10.1097/00007632- 199808010-00014 1:STN:280:DyaK1czmvF2quw%3D%3D 9704376 (Pubitemid 28433868)
48. AA White 3d WO Southwick RJ Deponte JW Gainor R Hardy 1973 Relief of pain by anterior cervical spine fusion for spondylosis: a report of sixty-five patients J Bone Joint Surg Am 55 525 534 4703205
49. C Wigfield J Robertson S Gill R Nelson 2003 Clinical experience with porous tantalum interbody implants in a prospective randomized controlled trial Br J Neurosurg 17 418 425 10.1080/02688690310001611206 1:STN:280: DC%2BD3srlsFKrsQ%3D%3D 14635746 (Pubitemid 37421566)
50. Zoëga B (1998) Cervical discectomy and fusion with or without plate fixation: a randomized clinical and radiographic study on outcome and cost-utility. Thesis, Göteborg University, Göteborg, Sweden
51. Zoëga B, Lind B (2005) A radiostereometric analysis (RSA) of TM cervical device (Hedrocel) in ACDF. Annual Meeting, Cervical Spine Research Society-European section, Rome, Italy
52. B Zoëga J Karrholm B Lind 2000 Outcome scores in degenerative cervical disc surgery Eur Spine J 9 137 143 10.1007/s005860050224 10823430
53. B Zoëga J Kärrholm B Lind 2003 Mobility provocation radiostereometry in anterior cervical spine fusions Eur Spine J 12 6 631 636 10.1007/s00586-001-0362-x 14579135 (Pubitemid 38096071)
54. X Zou H Li X Teng Q Xue N Egund M Lind C Bunger 2005 Pedicle screw fixation enhances anterior lumbar interbody fusion with porous tantalum cages: an experimental study in pigs Spine 30 E392 E399 10.1097/01.brs.0000170588. 80377.3f 16025015