Long-term clinical and radiographic outcomes of cervical disc replacement with the Prestige disc: results from a prospective randomized controlled clinical trial

Presented at the 2009 Joint Spine Section Meeting

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Object

The purpose of this study was to determine long-term clinical outcomes in patients undergoing anterior cervical surgery in which a cervical disc prosthesis was used to treat single-level degenerative cervical disc disease.

Methods

In this prospective, nonblinded study, 541 patients at 32 investigational sites were randomly assigned to 1 of 2 treatment groups. The results of the investigational group, in which patients received the Prestige disc prosthesis, were compared with those of the control group, in which patients underwent an instrumented interbody fusion. Data were collected preoperatively, intraoperatively, and at 1.5, 3, 6, 12, 24, 36, and 60 months postoperatively. To date, 271 patients have completed 5 years of clinical follow-up (144 investigational and 127 control patients).

Results

Significant improvements in Neck Disability Index (NDI) scores, Physical Component Summary scores of the 36-Item Short-Form Health Survey, and neck and arm pain scores were achieved by 1.5 months in both groups and sustained at 5 years. The mean NDI improvements from preoperative scores were 35.4, 36.3, and 38.4 at 24, 36, and 60 months, respectively, in the investigational group. The corresponding mean NDI improvements were 33.9, 31.3, and 34.1 in the control group. The intergroup differences at both 36 and 60 months were significant (p = 0.008 and 0.022, respectively). The overall rates of maintenance or improvement in neurological status in the investigational group were 91.6%, 92.8%, and 95.0%, respectively, at 24, 36, and 60 months compared with 83.6%, 83.2%, and 88.9% in the control group (p = 0.006, 0.004, and 0.051, respectively). The implant effectively maintained angular motion, averaging more than 7.3° at 36 months and 6.5° at 60 months after surgery. No implant migration was observed up to 60 months. There were statistically significant differences between the investigational and control groups with regard to the rate of revision and supplemental fixation surgical procedures performed subsequent to the index procedure. Additional surgical procedures for adjacent-segment disease were observed in both treatment groups. Rates for surgery at adjacent levels trended lower in the investigational group (8 patients [11 surgeries]) compared with those in the control group (13 patients [16 surgeries]), but the differences were not statistically significant (p = 0.376). Some of the second surgeries involved both index and adjacent levels.

Conclusions

The Prestige disc maintains improved clinical outcomes and segmental motion after implantation at 5-year follow-up.

Abbreviations used in this paper:IDE = investigational device exemption; LOCF = last observation carried forward; NDI = Neck Disability Index; PCS = Physical Component Summary; SF-36 = 36-Item Short-Form Health Survey.

Article Information

Address correspondence to: J. Kenneth Burkus, M.D., The Hughston Clinic, 6262 Veterans Parkway, Columbus, Georgia, 31908-9517. email: jkb66@knology.net.

© AANS, except where prohibited by US copyright law.

Headings

Figures

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    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. A: Dynamic lateral radiograph showing extension measurement technique. B: Dynamic lateral radiograph showing flexion measurement technique.

  • View in gallery

    Mean NDI scores in the investigational group (solid line) and control group (broken line).

  • View in gallery

    Mean neck pain scores in the investigational group (solid line) and control group (broken line).

  • View in gallery

    Mean arm pain scores in the investigational group (solid line) and control group (broken line).

  • View in gallery

    Mean SF-36 PCS scores in the investigational group (solid line) and control group (broken line).

  • View in gallery

    Neurological success rates in the investigational group (black bars) and control group (gray bars).

  • View in gallery

    Mean angular motion at index surgical level in the investigational group (solid line) and control group (broken line).

References

1

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

2

Bazaz RLee MJYoo JU: Incidence of dysphagia after anterior cervical spine surgery: a prospective study. Spine 27:245324582002

3

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

4

Brown JAHavel PEbraheim NGreenblatt SHJackson WT: Cervical stabilization by plate and bone fusion. Spine 13:2362401988

5

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

6

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

7

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

8

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

9

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

10

Döhler 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

11

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

12

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

13

Gilad INissan M: A study of vertebra and disc geometric relations of the human cervical and lumbar spine. Spine 11:1541571986

14

Heller JGSasso RCPapadopoulos SMAnderson PAFessler RGHacker RJ: Comparison of BRYAN cervical disc arthroplasty with anterior cervical decompression and fusion: clinical and radiographic results of a randomized, controlled, clinical trial. Spine 34:1011072009

15

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

16

Ipsen BJKim DHJenis LGTromanhauser SGBanco RJ: Effect of plate position on clinical outcome after anterior cervical spine surgery. Spine J 7:6376422007

17

Kim SWLimson MAKim SBArbatin JJChang KYPark MS: Comparison of radiographic changes after ACDF versus Bryan disc arthroplasty in single and bi-level cases. Eur Spine J 18:2182312009

18

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 Suppl Spine262004

19

Li L: Re: Yang JY, Song HS, Lee M, et al. Adjacent level ossification development after anterior cervical fusion without plate fixation. Spine 2009;34:30–3. Spine 34:162616272009. (Letter)

20

Mendoza-Lattes SClifford KBartelt RStewart JClark CRBoezaart AP: Dysphagia following anterior cervical arthrodesis is associated with continuous, strong retraction of the esophagus. J Bone Joint Surg Am 90:2562632008

21

Mummaneni PVBurkus JKHaid RWTraynelis VCZdeblick TA: Clinical and radiographic analysis of cervical disc arthroplasty compared with allograft fusion: a randomized controlled clinical trial. J Neurosurg Spine 6:1982092007

22

Murrey DJanssen MDelamarter RGoldstein JZigler JTay B: Results of the prospective, randomized, controlled multicenter Food and Drug Administration investigational device exemption study of the ProDisc-C total disc replacement versus anterior discectomy and fusion for the treatment of 1-level symptomatic cervical disc disease. Spine J 9:2752862009

23

Park JBCho YSRiew KD: Development of adjacent-level ossification in patients with an anterior cervical plate. J Bone Joint Surg Am 87:5585632005

24

Park JBWatthanaaphisit TRiew KD: Timing of development of adjacent-level ossification after anterior cervical arthrodesis with plates. Spine J 7:6336362007

25

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

26

Robertson JTMetcalf NH: Long-term outcomes after implantation of the PRESTIGE I disc in an end-stage indication: 4-year results from a pilot study. Neurosurg Focus 17:3E102004

27

Smith-Hammond CANew KCPietrobon RCurtis DJScharver CHTurner DA: Prospective analysis of incidence and risk factors of dysphagia in spine surgery patients: comparison of anterior cervical, posterior cervical, and lumbar procedures. Spine 29:144114462004

28

Steinmetz MPPatel RTraynelis VResnick DKAnderson PA: Cervical disc arthroplasty compared with fusion in a workers' compensation population. Neurosurgery 63:7417472008

29

Wigfield CGill 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

30

Wigfield CCGill SSNelson RJMetcalf NHRobertson JT: The new Frenchay artificial cervical joint: results from a two-year pilot study. Spine 27:244624522002

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