Analysis of the three United States Food and Drug Administration investigational device exemption cervical arthroplasty trials

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Object

There are now 3 randomized, multicenter, US FDA investigational device exemption, industry-sponsored studies comparing arthroplasty with anterior cervical discectomy and fusion (ACDF) for single-level cervical disease with 2 years of follow-up. These 3 studies evaluated the Prestige ST, Bryan, and ProDisc-C artificial discs. The authors analyzed the combined results of these trials.

Methods

A total of 1213 patients with symptomatic, single-level cervical disc disease were randomized into 2 treatment arms in the 3 randomized trials. Six hundred twenty-one patients received an artificial cervical disc, and 592 patients were treated with ACDF. In the three trials, 94% of the arthroplasty group and 87% of the ACDF group have completed 2 years of follow-up. The authors analyzed the 2-year data from these 3 trials including previously unpublished source data. Statistical analysis was performed with fixed and random effects models.

Results

The authors' analysis revealed that segmental sagittal motion was preserved with arthroplasty (preoperatively 7.26° and postoperatively 8.14°) at the 2-year time point. The fusion rate for ACDF at 2 years was 95%. The Neck Disability Index, 36-Item Short Form Health Survey Mental, and Physical Component Summaries, neck pain, and arm pain scores were not statistically different between the groups at the 24-month follow-up. The arthroplasty group demonstrated superior results at 24 months in neurological success (RR 0.595, I2 = 0%, p = 0.006). The arthroplasty group had a lower rate of secondary surgeries at the 2-year time point (RR 0.44, I2 = 0%, p = 0.004). At the 2-year time point, the reoperation rate for adjacent-level disease was lower for the arthroplasty group when the authors analyzed the combined data set using a fixed effects model (RR 0.460, I2 = 2.9%, p = 0.030), but this finding was not significant using a random effects model. Adverse event reporting was too heterogeneous between the 3 trials to combine for analysis.

Conclusions

Both anterior cervical discectomy and fusion as well as arthroplasty demonstrate excellent 2-year surgical results for the treatment of 1-level cervical disc disease with radiculopathy. Arthroplasty is associated with a lower rate of secondary surgery and a higher rate of neurological success at 2 years. Arthroplasty may be associated with a lower rate of adjacent-level disease at 2 years, but further follow-up and analysis are needed to confirm this finding.

Abbreviations used in this paper: ACDF = anterior cervical discectomy and fusion; BMI = body mass index; IDE = investigational device exemption; MCS = Mental Component Summary; NDI = neck disability index; NNT = number needed to treat; PCS = Physical Component Summary; ROM = range of motion; RR = relative risk; SF-36 = 36-Item Short Form Health Survey; VAS = visual analog scale; WMD = weighted mean difference.

Article Information

* Drs. Upadhyaya and Wu contributed equally to this work

Address correspondence to: Jau-Ching Wu, M.D., Department of Neurosurgery, Neurological Institute, Taipei Veterans General Hospital Room 509, 17F, No. 201, Shih-Pai Road, Sec. 2, Beitou, Taipei 11217, Taiwan. email: jauching@gmail.com.

Please include this information when citing this paper: published online December 23, 2011; DOI: 10.3171/2011.6.SPINE10623.

© AANS, except where prohibited by US copyright law.

Headings

Figures

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    Combined results of NDI favored arthroplasty without statistical significance. Fixed effects analysis presented. The random effects model had similar outcomes.

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    The MCS (upper) and PCS (lower) scores of SF-36 for both arthroplasty and ACDF had no significant differences. Fixed effects analysis presented. The random effects model had similar outcomes.

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    Neck pain frequency (upper) and intensity (lower) had no significant differences between arthroplasty and ACDF. Fixed effects analysis presented. The random effects model had similar outcomes.

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    Arm pain frequency (upper) and intensity (lower) had no significant differences between arthroplasty and ACDF. Fixed effects analysis presented. The random effects model had similar outcomes.

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    The neurological success rate at 24 months postoperatively was better after arthroplasty than after ACDF. Fixed effects analysis presented. The random effects model had similar outcomes.

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    The overall secondary surgeries, including revision, removal, supplemental fixation, and reoperations, were significantly more likely to happen in the ACDF group at 24 months postoperatively. Fixed effects analysis is presented. The random effects model had similar outcomes.

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    Adjacent-level surgeries were more likely to happen in the ACDF group at 24 months postoperatively with statistical significance by the fixed effects model. When using the random effects model, there was a trend to favor arthroplasty. p = 0.052.

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    Examples of maintenance of ROM at the index level for each artificial disc: Prestige ST (A), Bryan (B), and ProDisc-C (C). Extension (left) and flexion (right) dynamic lateral radiographs of the cervical spine obtained during follow-up.

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