Evidence map›Paper›PMID 33973129›Full record

ArticleAnnals of biomedical engineering2021

In Silico Clinical Trials in the Orthopedic Device Industry: From Fantasy to Reality?

Philippe Favre, Ghislain Maquer, Adam Henderson, Daniel Hertig, Daniel Ciric, Jeffrey E Bischoff

Abstract read
In one paragraph

Article in Annals of biomedical engineering, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing 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

11 citing papers in PubMed.

  1. Rapid personalized computational modeling of the wrist.Medical engineering & physics · 2026
    Article
  2. Fractures Around Collared and Collarless Hip Stems Initiate in High Strain Regions: A Combined Cadaveric Experiment and Finite Element Analysis.Journal of orthopaedic research : official publication of the Orthopaedic Research Society · 2026
    Article
  3. Review
  4. Review
  5. Article
  6. Review
  7. Toward trustworthy medical deviceFrontiers in medicine · 2024
    Article
  8. Review
  9. Article
  10. Article
  11. 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

6 authors.

Philippe FavreZimmer Biomet, Zählerweg 4, 6300, Zug, Switzerland. philippe.favre@zimmerbiomet.com.ORCID http://orcid.org/0000-0003-3575-0023
Ghislain MaquerZimmer Biomet, Sulzerallee 8, 8404 , Winterthur, Switzerland.
Adam HendersonZimmer Biomet, Sulzerallee 8, 8404 , Winterthur, Switzerland.
Daniel HertigZimmer Biomet, Sulzerallee 8, 8404 , Winterthur, Switzerland.
Daniel CiricZimmer Biomet, Sulzerallee 8, 8404 , Winterthur, Switzerland.
Jeffrey E BischoffZimmer Biomet, 1800 West Center St, Warsaw, IN, 46580, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The orthopedic device industry relies heavily on clinical evaluation to confirm the safety, performance, and clinical benefits of its implants. Limited sample size often prevents these studies from capturing the full spectrum of patient variability and real-life implant use. The device industry is accustomed to simulating benchtop tests with numerical methods and recent developments now enable virtual "in silico clinical trials" (ISCT). In this article, we describe how the advancement of computer modeling has naturally led to ISCT; outline the potential benefits of ISCT to patients, healthcare systems, manufacturers, and regulators; and identify how hurdles associated with ISCT may be overcome. In particular, we highlight a process for defining the relevant patient risks to address with ISCT, the utility of a versatile software pipeline, the necessity to ensure model credibility, and the goal of limiting regulatory uncertainty. By complementing-not replacing-traditional clinical trials with computational evidence, ISCT provides a viable technical and regulatory strategy for characterizing the full spectrum of patients, clinical conditions, and configurations that are embodied in contemporary orthopedic implant systems.

Indexed as

Computer SimulationEquipment Failure AnalysisEuropeHumansIndustryOrthopedic EquipmentSoftwareClinical applicationFinite elementModeling and simulationOrthopedicsRegulatory submissionVirtual clinical trials

Identifiers

PMID33973129
PMCPMC8110242

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.