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10-year follow-up after implantation of the Bryan Cervical Disc Prosthesis

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Abstract

Purpose

Cervical arthroplasty is being used as an alternative for cervical fusion, but long-term follow-up results have rarely been reported. In this paper, we present 10-year follow-up results after implantation of the Bryan Cervical Disc Prosthesis in a single center.

Methods

89 patients underwent implantation of a single-level Bryan Cervical Disc Prosthesis to treat radiculopathy and/or myelopathy. Clinical (Neurological Success, Neck Disability Index (NDI), Neck- and Arm-Pain, and SF-36) and radiological follow-up was prospectively organized up to 10 years after surgery. Adverse events and second surgeries were recorded and evaluated.

Results

Ten-year follow-up data were available for 72 (81%) patients. Maintenance or improvement of the neurological state was seen in 89% of patients after 10-year follow-up. SF-36 PCS scores improved significantly at all follow-up points. SF-36 MCS improvement was significant at 4 and 6 year, but not at 8- and 10-year follow-up. Significant improvement for NDI, and Neck- and Arm-Pain scores was found for the subgroup of patients in whom these data were available. Mean angular motion of the prosthesis at 10-year follow-up was 8.6°. Mobility of the device, defined as >2° of angular motion, was reached in 81% of patients. During the study period, 21 patients (24%) developed new or recurrent radiculopathy or myelopathy, the majority of these being treated conservatively. Seven patients (8%) required 8 additional spine surgeries to treat persistent or recurrent symptoms. Of these, 2 patients (2%) were reoperated at the index level and at 5 (6%) an adjacent level.

Conclusion

In this study, favorable long-term clinical outcome after implantation of the Bryan Cervical Disc Prosthesis was seen, with the majority of prostheses remaining mobile after 10-year follow-up. However, still 6% of patients required adjacent level surgery.

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Acknowledgements

The authors thank Medtronic for their help in retrieval and statistical analysis of the clinical data, in particular Dr. David Wootten, Ph.D. The support of Pat Wilson and Newt Metcalf, both from Medtronic Cervical Spine therapies, is highly appreciated.

Author information

Authors and Affiliations

  1. Department of Neurosurgery, University Hospitals Leuven, Leuven, Belgium

    Joost Dejaegher, Johannes van Loon, Frank Van Calenbergh & Jan Goffin

  2. Division of Biomechanics, KU Leuven, Heverlee, Belgium

    Joris Walraevens

  3. Department of Radiology, University Hospitals Leuven, Leuven, Belgium

    Philippe Demaerel

Authors
  1. Joost Dejaegher
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  2. Joris Walraevens
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  3. Johannes van Loon
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  4. Frank Van Calenbergh
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  5. Philippe Demaerel
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  6. Jan Goffin
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Corresponding author

Correspondence to Joost Dejaegher.

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Conflict of interest

This study was financially supported by Medtronic. A non-study-related institutional grant for research and education was received from Medtronic as well. Except for the radiological part of the study, data collection was conducted in collaboration with Medtronic. Statistical analysis was performed in collaboration with NAMSA. None of the authors has personal financial interest in the investigational device.

Additional information

Results up to 6-year follow-up have been published before as part of a multicenter trial [18, 19] or as a single-center follow-up study [20].

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Dejaegher, J., Walraevens, J., van Loon, J. et al. 10-year follow-up after implantation of the Bryan Cervical Disc Prosthesis. Eur Spine J 26, 1191–1198 (2017). https://doi.org/10.1007/s00586-016-4897-2

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  • DOI: https://doi.org/10.1007/s00586-016-4897-2

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