Cervical Fusion vs. Artificial Disc Replacement (CADR)

Transcription

1 Cervical Fusion vs. Artificial Disc Replacement (CADR) Metanalysis of Class I Data on Results of Anterior Cervical Decompression and Fusion Kenneth A. Pettine, M.D. Lukas Eisermann, B.S. Materials and Methods: This is a metanalysis of all class data available from five FDA IDE studies involving ACDF 1

2 The five studies together comprise a sample of 1,154 single-level ACDF patients The true results of one level ACDF: 10% reoperation rate at two-year follow-up pseudoarthrosis adjacent level degeneration revision 70% clinical success ACF Downsides Adjacent level degeneration Slow recovery Pseudoarthrosis 2

3 Radiculopathy and Myelopathy at Segments Adjacent to Previous ACDF Symptomatic adjacent level disease has been reported to occur in more then 25% of patients within 8-10 years following ACDF with nearly half requiring re-operation. Hilibrand, et al. JBJS 1999: 81(4) Hypermobility Cervical fusion causes hypermobility of adjacent levels especially the superior motion segment DiAngelo DJ, Robertson JT, Metcalf NH, et al. Biomechanical testing of an artificial cervical joint and an anterior cervical plate. J Spinal Disord Tech 2003;16: Puttlitz CM, Rousseau MA, Xu Z, et al. Intervertebral disc replacement maintains cervical spine kinetics. Spine (Phila Pa 1976) 2004;29: Park DH, Ramakrishnan P, Cho TH, et al. Effect of lower two-level anterior cervical fusion on the superior adjacent level. J Neurosurg Spine 2007;7: Reitman CA, Hipp JA, Nguyen L, et al. Changes in segmental intervertebral motion adjacent to cervical arthrodesis: a prospective study. Spine 2004;29:E Katsura A, Hukuda S, Sauhashi Y, et al. Kyphotic malalignment after anterior cervical fusion is one of the factors promoting the degenerative process in adjacent intervertebral levels. Eur Spine J 2001;10: Matsunga S, Kabayama S, Yamamoto T, et al. Strain on intervertebral discs after anterior cervical decompression and fusion. Spine 1999;24: Eck JC, Humphreys SC, Lim TH, et al. Biomechanical study on the effect of cervical spine fusion on adjacent-level intradiscal pressure and segmental motion. Spine (Phila Pa 1976) 2002;27: Maiman, et al. Biomechanical effect of ACDF. Biomed. Mater Eng. 1999:9(1) Degeneration Cervical ACDF causes accelerated adjacent level degeneration Goffin J, Van Loon J, Van Calenbergh F, et al. Long-term results after anterior cervical fusion and osteosynthetic stabilization for fractures and/or dislocations of the cervical spine. J Spinal Disord 1995;8: Hilibrand AS, Carlson GD, Palumbo MA, et al. Radiculopathy and myelopathy at segments adjacent to the site of a previous anterior cervical arthrodesis. J Bone Joint Surg Am 1999;81: Gore DR, Sepic SB. Anterior cervical fusion for degenerated or protruded discs: a review of one hundred forty-six patients. Spine 1984;9: Robertson JT, Papadopoulos SM, Traynelis VC. Assessment of adjacent-segment disease in patients treated with cervical fusion or arthroplasty: a prospective 2-year study. J Neurosurg Spine 2005;3: Ishihara H, Kanamori M, Kawaguchi Y, et al. Adjacent segment disease after anterior cervical interbody fusion. Spine J 2004;4: Baba H, Furusawa N, Imura S, et al. Late radiographic findings after anterior cervical fusion for spondylotic myeloradiculopathy. Spine (Phila Pa 1976) 1993;18: Cherubino P, Benazzo F, Borromeo U, et al. Degenerative arthritis of the adjacent spinal joints following anterior cervical spinal fusion: clinicoradiologic and statistical correlations. Ital J Orthop Traumatol 1990;16: Katsura A, Hukuda S, Sauhashi Y, et al. Kyphotic malalignment after anterior cervical fusion is one of the factors promoting the degenerative process in adjacent intervertebral levels. Eur Spine J 2001;10: Yue WM, Brodner W, Highland TR. Long-term results after anterior cervical discectomy and fusion with allograft and plating: a 5- to 11-year radiologic and clinical follow-up study. Spine 2005;30: Matsmoto et al. ACDF accelerates adjacent level degeneration. Spine 2010: 35 (1) Tchako, et al. Stress changes in intervertebral disc in cervical spine due to fusion. J Biomech. Eng. 2009: 131(5) Lopez-Espring et al. Multilevel ACDF and effect on disc degeneration. Spine 2006: 31(9) 3

4 Anterior Cervical Fusion (ACF): Cervical discectomy with interbody fusion is a reasonably successful procedure Predictable, reproducible results In one-level procedures: class one data indicates an FDA success rate of 70% and a re-operation rate of 10% at two year follow-up. Desirable Characteristics of Artificial Cervical Discs Preservation/restoration of normal ROM Multiple level implantation possible Better clinical results Less re-operations Rapid recovery Kinematics C ADR does not alter the adjacent motion level kinematics DiAngelo DJ, Robertson JT, Metcalf NH, et al. Biomechanical testing of an artificial cervical joint and an anterior cervical plate. J Spinal Disord Tech 2003;16: Chang UK, Kim DH, Lee MC, et al. Range of motion change after cervical arthroplasty with ProDisc-C and Prestige artificial discs compared with anterior cervical discectomy and fusion. J Neurosurg Spine 2007;7:40-6. DiAngelo DJ, Foley KT. An improved biomechanical testing protocol for evaluating spinal arthroplasty and motion preservation devices in a multi-level human cadaveric cervical model. Neurosurg Focus 2004;17:E4. DiAngelo DJ, Foley KT, Morrow BR, et al. In vitro biomechanics of cervical disc arthroplasty with the ProDisc-C total disc implant. Neurosurg Focus 2004;17:E7. Dmitriev AE, Cunningham BW, Hu N, et al. Adjacent level intradiscal pressure and segmental kinematics following a cervical total disc arthroplasty: an in vitro human cadaveric model. Spine (Phila Pa 1976) 2005;30: Kotani Y, Cunningham BW, Abumi K, et al. Multidirectional flexibility analysis of cervical artificial disc reconstruction: in vitro human cadaveric spine model. J Neurosurg Spine 2005;2: Puttlitz CM, Rousseau MA, Xu Z, et al. Intervertebral disc replacement maintains cervical spine kinetics. Spine (Phila Pa 1976) 2004;29: Rousseau MA, Cottin P, Levante S, et al. In vivo kinematics of two types of ball-and-socket cervical disc replacements in the sagittal plane: cranial versus caudal geometric center. Spine (Phila Pa 1976) 2008;33:E6-9. Phillips, F. Rush Ortho. J Wigfield, et al. Biomech. Effect of CADR. J. Spinal Disord. Tech. 2003:16(5) Park, et al. Adj. level kinematics following CADR. Cervical Spine Research Society

5 Metanalysis of Comparative Outcomes Following Cervical Arthroplasty or Anterior Cervical Fusion By Paul McAfee, M.D., M.B.A Spine, Vol. 37, No. 11, p Study Design Metanalysis of 4 F.D.A. I.D.E. clinical trials Bryan Prestige Pro-Disc C PCM 1,608 patients at 98 sites Results Overall Success: Fusion 70.8% C ADR 77.6% p<0.007 NDI Neurologic Status Survivorship p<0.103 p<0.005 p<

6 Eight year Clinical and Radiological Follow-up of Bryan CADR Conclusion At eight year follow-up Bryan CADR maintains favorable clinical and radiological results with preservation of movement and satisfactory clinical outcomes Quon, et al. Spine 2011: 36(8) Five year ProDisc C F.D.A. I.D.E. results Conclusion Data shows significant clinical improvement was maintained from 2 year follow-up No deterioration of outcomes. ProDisc C is safe and effective Rick Delamarter, M.D. Conclusions for CADR vs. Fusion C ADR Faster Recovery Less Re-operations Better Clinical Outcomes Less Adjacent Level Degeneration Similar Cost 6

7 Thank You! 7