Häckel, Sonja; Gaff, Jessica; Pabbruwe, Moreica; Celenza, Alana; Kern, Michael; Taylor, Paul; Miles, Andrew; Cunningham, Greg (2024). Heterotopic ossification, osteolysis and implant failure following cervical total disc replacement with the M6-C™ artificial disc. European spine journal, 33(3), pp. 1292-1299. Springer 10.1007/s00586-024-08129-5
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INTRODUCTION
A recent study reported a 34% mid-term revision rate after M6-C™ cervical total disc replacement (CTDR) for wear-related osteolysis. Here, we aim to investigate the prevalence, risk factors, and radiographic characteristics of periprosthetic bony changes and implant failure of the M6-C™ artificial disc.
METHODS
We retrospectively analysed radiographic (conventional X-ray, CT scan) and clinical outcomes (EQ-5D-5L, Neck Disability Index (NDI), and Visual Analog Scale (VAS) for neck and arm pain) data collected during routine follow-up of patients who underwent CTDR with the M6-C™ between 2011 and 2015.
RESULTS
In total, 85 patients underwent CTDR with the M6-C™. Follow-up data were available for 43 patients (54% female, mean age 44 years) with 50 implants and a mean follow-up of 8.1 years (6.5-11 years). Implant failure with the presence of severe osteolysis was identified in 5 (12%) patients who were all male (p = 0.016) and implanted at the C5/6 level (p = 0.11). All failed implants required revision surgery. The overall prevalence of osteolysis was 44% (22/50 implants) and 34% (17/50 implants) for significant heterotopic ossification. Patients with high-grade osteolysis showed higher VAS arm pain (p = 0.05) and lower EQ-5D-VAS health VAS (p = 0.03).
CONCLUSION
We report a lower reoperation rate for failed M6-C™ implants than previously published, but confirmed that osteolysis and heterotopic ossification are common following CTDR with the M6-C™ and may be asymptomatic. Therefore, we strongly recommend ongoing clinical and radiographic monitoring after CTDR with the M6-C™, particularly for male patients implanted at the C5/6 level.
Item Type: |
Journal Article (Original Article) |
|---|---|
Division/Institute: |
04 Faculty of Medicine > Department of Orthopaedic, Plastic and Hand Surgery (DOPH) > Clinic of Orthopaedic Surgery |
UniBE Contributor: |
Häckel, Sonja |
Subjects: |
600 Technology > 610 Medicine & health |
ISSN: |
1432-0932 |
Publisher: |
Springer |
Language: |
English |
Submitter: |
Pubmed Import |
Date Deposited: |
19 Feb 2024 12:46 |
Last Modified: |
19 Mar 2024 00:15 |
Publisher DOI: |
10.1007/s00586-024-08129-5 |
PubMed ID: |
38363365 |
Uncontrolled Keywords: |
Artificial disc replacement surgery Cervical arthroplasty Cervical disc prosthesis Cervical total disc replacement Heterotopic ossification Implant failure M6-C™ Osteolysis Periprosthetic complications |
BORIS DOI: |
10.48350/192976 |
URI: |
https://boris.unibe.ch/id/eprint/192976 |
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