ArticleDer Orthopade2012
[Revision rates in journal publications on joint prostheses with noticeably high failure rates in register data sets].
Article in Der Orthopade, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
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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.
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.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
background and aim of studyThe value of outcome quality data from clinical studies is an issue of controversial debate particularly in the context of adverse events. The aim of this study is to present and evaluate the data available from clinical studies for products that show inferior outcome in registers and to assess the possibility to draw valid conclusions from these data. STUDY DESIGN AND ANALYTICAL
methodsBased on a structured literature research, a comparative analysis was made of the revision rates of 12 products showing significantly inferior average results in registers. The primary outcome parameter was the revision rate for any reason calculated using a standardized methodology and the parameter of revisions per 100 observed component years.
resultsFor 5 out of 12 products not a single comparable study was available and relatively few data were available for the remaining products. A conventional meta-analysis revealed that only three products showed results that were comparable with those from registers. For 75% of products good results were published. There was not a single case where it would have been possible to identify or isolate the problems that had led to the underperformance observed on the basis of clinical studies alone. DISCUSSION: Clinical sample-based studies are not a suitable and reliable means to recognize potential product or handling problems and avoid risks for patients and physicians. In this respect registers can provide an essential contribution.
Indexed as
Identifiers
22914916What OpenQuestion holds
Registered trials
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.