Evidence map›Paper›PMID 32313795›Full record

ArticleGlobal spine journal2020

Mechanical Stability of the Prodisc-C Vivo Cervical Disc Arthroplasty: A Preliminary, Observational Study Using Radiostereometric Analysis.

Miranda L van Hooff, Petra J C Heesterbeek, Maarten Spruit

Open access · goldAbstract read
In one paragraph

Article in Global spine journal, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 49% 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

1 citing paper in PubMed, 6 citations in OpenAlex.

  1. [Comparison of short-term effectiveness of Prodisc-C Vivo artificial disc replacement and Zero-P fusion for treatment of single-segment cervical spondylosis].Zhongguo xiu fu chong jian wai ke za zhi = Zhongguo xiufu chongjian waike zazhi = Chinese journal of reparative and reconstructive surgery · 2022
    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

3 authors at 2 institutions in 1 country.

Miranda L van HooffSint Maartenskliniek, Nijmegen, the Netherlands.ORCID https://orcid.org/0000-0001-5313-6436
Petra J C HeesterbeekSint Maartenskliniek, Nijmegen, the Netherlands.
Maarten SpruitSint Maartenskliniek, Nijmegen, the Netherlands.
Sint Maartenskliniek · NLRadboud University Nijmegen · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

STUDY

designProspective cohort study.

objectiveTo investigate the primary stability of the Prodisc-C Vivo cervical disc arthroplasty with regard to the adjacent cervical vertebrae using radiostereometric analysis (RSA), and to monitor its clinical performance.

methodsSixteen patients with degenerative cervical disc disease were included. RSA radiographs were obtained at the first postoperative day, at 6 weeks, 3 months, and 6 months postoperatively. Migration (translation [mm]) of the superior and inferior implant components were measured with model-based RSA, expressed along the 3 orthogonal axes, and calculated as total translation. Clinical outcomes were Neck Disability Index, numeric rating scales for neck and arm pain, Likert-type scales for satisfaction, and adverse events. Range of motion was reported as C2-C7 flexion-extension mobility (ROM).

resultsAt final follow-up, no significant increase over time in median total translation was found. One inferior and 3 superior components subsided but were asymptomatic. ROM remained stable and clinical outcomes improved over time. Although 3 patients were unsatisfied and 3 adverse events occurred, this was not related to translation of the components.

conclusionsOn a group level, both components of the Prodisc-C Vivo cervical disc arthroplasty remained stable over time and below the clinical threshold of 1 mm. Individual outliers for translation were not clinically relevant and probably related to settling of the components into the vertebral endplates. RSA allowed us to perform a preliminary but accurate study on the micromotion of a new cervical disc replacement in a small sample size, without putting large numbers of patients at risk.

Indexed as

arthroplastyimplantsoutcomeradiostereometric analysisspine

Identifiers

PMID32313795
PMCPMC7160805
OpenAlexW2945697308

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.