Clinical and radiographic analysis of cervical disc arthroplasty compared with allograft fusion: a randomized controlled clinical trial

Restricted access

Object

The authors report the results of a prospective randomized multicenter study in which the results of cervical disc arthroplasty were compared with anterior cervical discectomy and fusion (ACDF) in patients treated for symptomatic single-level cervical degenerative disc disease (DDD).

Methods

Five hundred forty-one patients with single-level cervical DDD and radiculopathy were enrolled at 32 sites and randomly assigned to one of two treatment groups: 276 patients in the investigational group underwent anterior cervical discectomy and decompression and arthroplasty with the PRESTIGE ST Cervical Disc System (Medtronic Sofamor Danek); 265 patients in the control group underwent decompressive ACDF. Eighty percent of the arthroplasty-treated patients (223 of 276) and 75% of the control patients (198 of 265) completed clinical and radiographic follow-up examinations at routine intervals for 2 years after surgery.

Analysis of all currently available postoperative 12- and 24-month data indicated a two-point greater improvement in the neck disability index score in the investigational group than the control group. The arthroplasty group also had a statistically significant higher rate of neurological success (p = 0.005) as well as a lower rate of secondary revision surgeries (p = 0.0277) and supplemental fixation (p = 0.0031). The mean improvement in the 36-Item Short Form Health Survey Physical Component Summary scores was greater in the investigational group at 12 and 24 months, as was relief of neck pain. The patients in the investigational group returned to work 16 days sooner than those in the control group, and the rate of adjacent-segment reoperation was significantly lower in the investigational group as well (p = 0.0492, log-rank test). The cervical disc implant maintained segmental sagittal angular motion averaging more than 7°. In the investigational group, there were no cases of implant failure or migration.

Conclusions

The PRESTIGE ST Cervical Disc System maintained physiological segmental motion at 24 months after implantation and was associated with improved neurological success, improved clinical outcomes, and a reduced rate of secondary surgeries compared with ACDF.

Abbreviations used in this paper:ACDF = anterior cervical discectomy and fusion; DDD = degenerative disc disease; DSH = disc space height; FDA = Food and Drug Administration; MCS = Mental Component Summary; NDI = neck disability index; PCS = Physical Component Summary; SF-36 = 36-Item Short Form Health Survey; VB = vertebral body.

Article Information

Address reprint requests to: Praveen V. Mummaneni, M.D., Department of Neurological Surgery, University of California, San Francisco, 505 Parnassus Avenue, M-779, Box 0112, San Francisco, California 94143. email: vmum@aol.com.

© AANS, except where prohibited by US copyright law.

Headings

Figures

  • View in gallery

    Artist's rendering of the PRESTIGE ST Cervical Disc System implanted in the cervical spine.

  • View in gallery

    A: Artist's rendering (lateral view) of the cervical spine with implant in place. Sagittal-plane angulation is measured using the Cobb method. A line is drawn perpendicular to the superior and inferior endplates of the adjacent vertebrae. B and C: Dynamic lateral radiographs show flexion (B) and extension (C) measurement techniques.

  • View in gallery

    Graphic and tabular summaries of follow-up rates.

  • View in gallery

    Graphic and tabular representations of NDI scores. The NDI was used to measure the effects of neck pain on a patient's function in performing activities of daily living. (The probability values were derived using an analysis of variance. One-sided probability values are reported here. The preoperative score is treated as a covariate in the analysis.)

  • View in gallery

    Bar graph demonstrating NDI score success. The NDI success criterion is a function of the preoperative NDI score. A minimum 15-point postoperative improvement in NDI score was required to be deemed a successful outcome.

  • View in gallery

    Bar graphs showing the SF-36 PCS scores (upper) and MCS scores (lower). The PCS score reflects the Physical Functioning, Role–Physical Bodily Pain, and General Health outcomes; the MCS score represents Vitality, Social Functioning, Role–Emotional, and Mental Health outcomes. (The probability values were derived using an analysis of covariance. One-sided probability values are reported here. The preoperative score is treated as a covariate in analysis.)

  • View in gallery

    Bar graphs demonstrating the neck pain (upper) and arm pain (lower) scores. Numeric rating scales were used to assess neck/arm pain intensity and duration. (The probability values were derived using an analysis of covariance. One-sided probability values are reported here. The preoperative score is treated as a covariate in analysis.)

  • View in gallery

    Bar graph showing mean neurological success rates, which were based on maintenance or improvement in postoperative neurological functioning compared with preoperative status. The superiority probability values were calculated using the Fisher exact test. One-sided superiority probability values are reported here.

  • View in gallery

    Line graph demonstrating segmental sagittal angular motion at the treated level.

  • View in gallery

    Bar graph providing a summary of overall clinical success rates.

References

1

Adamson TE: Microendoscopic posterior cervical laminofo-raminotomy for unilateral radiculopathy: results of a new technique in 100 cases. J Neurosurg 95:1 Suppl51572001

2

Baba HFurusawa NImura SKawahara NTsuchiya HTomita K: Late radiographic findings after anterior cervical fusion for spondylotic myeloradiculopathy. Spine 18:216721731993

3

Bartolomei JCTheodore NSonntag VK: Adjacent level degeneration after anterior cervical fusion: a clinical review. Neurosurg Clin N Am 16:5755872005

4

Bertagnoli RYue JJPfeiffer FFenk-Mayer ALawrence JPKershaw T: Early results after ProDisc-C cervical disc replacement. J Neurosurg Spine 2:4034102005

5

Boakye MMummaneni PVGarrett MRodts GEHaid RW: Anterior cervical discectomy and fusion using polyetherether-ketone spacer and bone morphogenetic protein. J Neurosurg Spine 2:5215252005

6

Bohlman HHEmery SEGoodfellow DBJones PK: Robinson anterior cervical discectomy and arthrodesis for cervical radiculopathy. Long-term follow-up of one hundred and twenty-two patients. J Bone Joint Surg Am 75:129813071993

7

Brodke DSZdeblick TA: Modified Smith-Robinson procedure for anterior cervical discectomy and fusion. Spine 17:10 SupplS427S4301992

8

Brown JAHavel PEbraheim NGreenblott SMJackson WT: Cervical stabilization by plate and bone fusion. Spine 13:2362481988

9

Cherubino PBenazzo FBorromeo UPerle S: Degenerative arthritis of the adjacent spinal joints following anterior cervical spinal fusion: clinicoradiologic and statistical correlations. Ital J Orthop Traumatol 16:5335431990

10

Connolly PJEsses SIKostuik JP: Anterior cervical fusion: outcome analysis of patients with and without anterior cervical plates. J Spinal Disord 9:2022061996

11

Cummins BHRobertson JTGill SS: Surgical experience with an implanted artificial cervical joint. J Neurosurg 88:9439481998

12

DiAngelo DJRoberston JTMetcalf NHMcVay BJDavis RC: Biomechanical testing of an artificial cervical joint and an anterior cervical plate. J Spinal Disord Tech 16:3143232003

13

Dmitriev AECunningham BWHu NSell GVigna FMcAfee PC: Adjacent level intradiscal pressure and segmental kinematics following a cervical total disc arthroplasty: an in vitro human cadaveric model. Spine 30:116511722005

14

Dohler JRKahn MRHughes SP: Instability of the cervical spine after anterior interbody fusion. A study on its incidence and clinical significance in 21 patients. Arch Orthop Trauma Surg 104:2472501985

15

Eck JCHumphreys SCLim THJeong STKim JGHodges SD: Biomechanical study on the effect of cervical spine fusion on adjacent level intradiscal pressure and segmental motion. Spine 27:243124342002

16

Emery SEBolesta MJBanks MAJones PK: Robinson anterior cervical fusion. Comparison of the standard and modified techniques. Spine 19:6606631994

17

Fager CA: Posterolateral approach to ruptured median and paramedian cervical disk. Surg Neurol 20:4434521983

18

Fessler RGKhoo LT: Minimally invasive cervical microendoscopic foraminotomy: an initial clinical experience. Neurosurgery 51:5 SupplS37S452002

19

Goffin JCasey AKehr PLiebig KLind BLogroscino C: Preliminary clinical experience with the Bryan Cervical Disc prosthesis. Neurosurgery 51:8408472002

20

Goffin JVan Calenbergh Fvan Loon JCasey AKehr PLiebig K: Intermediate follow-up after treatment of degenerative disc disease by the Bryan Cervical Disc Prosthesis: single-level and bi-level. Spine 28:267326782003

21

Goffin Jvan Loon JVan Calenbergh FPlets C: Long-term results after anterior cervical fusion and osteosynthetic stabilization for fractures and/or dislocations of the cervical spine. J Spinal Disord 8:4995081995

22

Gore DRSepic SB: Anterior cervical fusion for degenerated or protruded discs. A review of one hundred forty-six patients. Spine 9:6676711984

23

Hilibrand ASCarlson GDPalumbo MJones PKBohlman HH: Radiculopathy and myelopathy at segments adjacent to the site of a previous anterior cervical arthrodesis. J Bone Joint Surg Am 81:5195281999

24

Hilibrand ASYoo JUCarlson GDBohlman HH: The success of anterior cervical arthrodesis adjacent to a previous fusion. Spine 22:157415791997

25

Kaiser MGHaid RW JrSubach BRBarnes BRodts GE Jr: Anterior cervical plating enhances arthrodesis after discectomy and fusion with cortical allograft. Neurosurgery 50:2292362002

26

Krag MHRobertson RAJohnson CCStein AC: Anterior cervical fusion using a modified tricortical bone graft: a radiographic analysis of outcome. J Spinal Disord 10:4204301997

27

Kulkarni VRajshekhar VRaghuram L: Accelerated spondylotic changes adjacent to the fused segment following central cervical corpectomy: magnetic resonance imaging study evidence. J Neurosurg 100:1 Suppl262004

28

Lafuente JCasey ATPetzold ABrew S: The Bryan cervical disc prosthesis as an alternative to arthrodesis in the treatment of cervical spondylosis: 46 consecutive cases. J Bone Joint Surg Br 87:5085122005

29

Matsunaga SKabayama SYamamoto TYone KSakou TNakanishi K: Strain on intervertebral discs after anterior cervical decompression and fusion. Spine 24:6706751999

30

McHorney CAWare JE JrLu JFSherbourne CD: The MOS 36-item Short-Form Health Survey (SF-36): III. Tests of data quality, scaling assumptions, and reliuability across diverse patient groups. Med Care 32:40661994

31

Mummaneni PVHaid RW: The future in the care of the cervical spine: interbody fusion and arthroplasty. J Neurosurg Spine 1:1551592004

32

Mummaneni PVSrinivasan JKHaid RWMizuno J: Overview of anterior cervical plating. Spinal Surgery 16:2072152002

33

Porchet FMetcalf NH: Clinical outcomes with the Prestige II cervical disc: preliminary results from a prospective randomized clinical trial. Neurosurg Focus 17:3E62004

34

Robertson JMetcalf N: Long-term outcome after implantation of the Prestige I disc in an end-stage indication: 4-year results form a pilot study. Neurosurg Focus 17:3E102004

35

Robinson RAWalker AEFerlic DCWiecking DK: The results of anterior interbody fusion of the cervical spine. J Bone Joint Surg Am 44:156915871962

36

Sekhon L: Cervical arthroplasty in the management of spondylotic myelopathy. J Spinal Disord Tech 16:3073132003

37

Southwick WORobinson RN: Surgical approaches to the vertebral bodies in the cervical and lumbar regions. J Bone Joint Surg Am 39:6316431959

38

Traynelis V: The Prestige cervical disc replacement. Spine J 4:6 Suppl310S314S2004

39

Vernon HMior S: The Neck Disability Index: a study of reliability and validity. J Manipulative Physiol Ther 14:4094151991

40

Westaway MStratford PBinkley J: The patient-specific functional scale: validation of its use in persons with neck dysfunction. J Orthop Sports Phys Ther 27:3313381998

41

Wigfield CCGill SNelson RLangdon IMetcalf NRobertson J: Influence of an artificial cervical joint compared with fusion on adjacent-level motion in the treatment of degenerative cervical disc disease. J Neurosurg 96:1 Suppl17212002

42

Wigfield CCGill SNelson RMetcalf NRobertson J: The new Frenchay artificial cervical joint: results from a two-year pilot study. Spine 27:244624522002

43

Wigfield CCSkrzypiec DJackowski AAdams MA: Internal stress distribution in cervical intervertebral discs: the influence of an artificial cervical joint and simulated anterior interbody fusion. J Spinal Disord Tech 16:4414492003

44

Williams JLAllen MB JrHarkess JW: Late results of cervical discectomy and interbody fusion: some factors influencing the results. J Bone Joint Surg Am 55:2772861968

TrendMD

Metrics

Metrics

All Time Past Year Past 30 Days
Abstract Views 77 77 40
Full Text Views 94 94 19
PDF Downloads 119 119 17
EPUB Downloads 0 0 0

PubMed

Google Scholar