Evidence map›Paper›PMID 40681342›Full record

ArticleInternational journal of spine surgery2025

Rates of Osteolysis for Commercially Available Cervical Disc Arthroplasty Devices in the United States: A Manufacturer and User Facility Device Experience Database Analysis.

Pierce Nunley, Andrew Meyers, Danny Mangual-Perez, Emily Young, Henry Googe, Ian Armstrong, Stacie Tran, Marcus Stone

Erratum issuedAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in International journal of spine surgery, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors.

Pierce NunleyDepartment of Orthopaedic Surgery, Spine Institute of Louisiana, Shreveport, LA, USA pnunley@louisianaspine.org.
Andrew MeyersDepartment of Orthopaedic Surgery, Spine Institute of Louisiana, Shreveport, LA, USA.
Danny Mangual-PerezDepartment of Orthopaedic Surgery, Spine Institute of Louisiana, Shreveport, LA, USA.
Emily YoungDepartment of Orthopaedic Surgery, Spine Institute of Louisiana, Shreveport, LA, USA.
Henry GoogeDepartment of Orthopaedic Surgery, Spine Institute of Louisiana, Shreveport, LA, USA.
Ian ArmstrongDepartment of Orthopaedic Surgery, Spine Institute of Louisiana, Shreveport, LA, USA.
Stacie TranClinical Affairs, The Spine Network, Highland, UT, USA.
Marcus StoneClinical Affairs, The Spine Network, Highland, UT, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCervical disc arthroplasty (CDA) represents a promising alternative to anterior cervical discectomy and fusion for the treatment of symptomatic degenerative disc disease in appropriately selected patients. It offers the potential benefits of motion preservation and reduced adjacent segment degeneration. However, like any surgical procedure, CDA has associated risks and complications. Among these, postoperative osteolysis, although rare, warrants further investigation to fully understand its incidence, causes, and optimal management strategies. This study's purpose is to elucidate the current incidence of osteolysis following CDA.

methodsThe Manufacturer and User Facility Device Experience (MAUDE) database was queried using the "Brand Name" function for: "Mobi C," "Mobi-C," "Prodisc -C," "Prodisc C," "Bryan," "PCM," "Secure-C," "Secure C," "Prestige," "M6," and "Simplify" from 1 January 2005 to 30 September 2024. Search results were further queried for the word "osteolysis." Osteolysis percentage was calculated as a proportion of a total number of valid reports. The findings from this study were compared with published literature.

resultsThe total number of osteolysis events reported in the MAUDE database for each disc was 2 Mobi-C, 1 Prodisc-C, 3 Bryan, 0 PCM, 0 Secure-C, 2 Prestige, 138 M6, and 16 Simplify. The highest rate of osteolysis was found in the M6 (36.2%) and Simplify discs (25.8%). Results from the MAUDE database were consistent with previously published literature.

conclusionWhile acknowledging the limitations of the MAUDE database, the data presented give rise to substantial concerns regarding the association of osteolysis with the M6 implant. While the reports on the Simplify disc are recent, the current findings indicate a necessity for careful monitoring. Although surgeon participation in the MAUDE database is optional, it is imperative to promptly report any issues with recent technology to ensure fellow surgeons and the public are well informed. CLINICAL RELEVANCE: This report brings to light a clinical concern of osteolysis in cervical TDR surgeries that was not previously discussed. Using these findings, surgeons can look out for signs of osteolysis in earlier follow-up to provide early treatment. LEVEL OF EVIDENCE: 4:

Indexed as

cervical disc replacementCTDRosteolysis

Identifiers

PMID40681342
PMCPMC12679448

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.