Evidence map›Paper›PMID 38363365›Full record

ArticleEuropean spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society2024

Heterotopic ossification, osteolysis and implant failure following cervical total disc replacement with the M6-C™ artificial disc.

Sonja Häckel, Jessica Gaff, Moreica Pabbruwe, Alana Celenza, Michael Kern, Paul Taylor, Andrew Miles, Greg Cunningham

Open access · hybridAbstract read
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In one paragraph

Article in European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
9.7field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 17 citations in OpenAlex.

  1. Review
  2. Explant analysis of two rhine cervical discs.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2026
    Article
  3. Article
  4. Complication Profiles Leading to Revision Surgery After Cervical Disc Arthroplasty.HSS journal : the musculoskeletal journal of Hospital for Special Surgery · 2026
    Article
  5. Article
  6. The Total Disc Replacement Osteolysis Grading Scale - a simple, reliable and quantifiable tool for assessing, managing and reporting osteolysis after cervical total disc replacement.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2026
    Article
  7. Review
  8. Beyond the two-year trial: real-World failure mechanisms of the simplify cervical disc.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2026
    Review
  9. Article
  10. Article
  11. Patient outcomes and surgical strategies in revision cervical arthroplasty following M6-C™ disc-related osteolysis.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2025
    Article
  12. The Future of Arthroplasty in the Spine.International journal of spine surgery · 2025
    Article
  13. Article
  14. Review
  15. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 4 institutions in 3 countries.

Sonja Häckel *Neurospine Institute, Murdoch, Australia.
Jessica Gaff *Neurospine Institute, Murdoch, Australia. jessica.gaff@neurospineinstitute.com.au.ORCID 0000-0002-4919-5078
Moreica PabbruweDepartment of Medical Engineering and Physics, Centre for Implant Technology and Retrieval Analysis, Royal Perth Hospital, Perth, Australia.
Alana CelenzaNeurospine Institute, Murdoch, Australia.
Michael KernNeurospine Institute, Murdoch, Australia.
Paul TaylorNeurospine Institute, Murdoch, Australia.
Andrew MilesNeurospine Institute, Murdoch, Australia.
Greg CunninghamNeurospine Institute, Murdoch, Australia.
St John of God Murdoch Hospital · AUCurtin University · AURoyal Perth Hospital · AUUniversity Hospital of Bern · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionA 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.

methodsWe 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.

resultsIn 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).

conclusionWe 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.

Indexed as

Intervertebral Disc DegenerationOssification, HeterotopicOsteolysisTotal Disc ReplacementAdultCervical VertebraeFemaleFollow-Up StudiesHumansMaleNeck PainRetrospective StudiesTreatment OutcomeArtificial disc replacement surgeryCervical arthroplastyCervical disc prosthesisCervical total disc replacementHeterotopic ossificationImplant failureM6-C™OsteolysisPeriprosthetic complications

Identifiers

PMID38363365
OpenAlexW4391883541

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.