Trial reportOrthopadie (Heidelberg, Germany)2022
[The use of knee prostheses with a hypoallergenic coating is safe in the medium term : A randomized controlled study].
Trial report in Orthopadie (Heidelberg, Germany), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled 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.
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
5 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.
- Mandatory Labelling of CMR Substances in Implants and Their Impact on Orthopedics and Trauma Surgery.Zeitschrift fur Orthopadie und Unfallchirurgie · 2026Pooled it
- No difference in patient reported outcome and inflammatory response after coated and uncoated total knee arthroplasty - a randomized controlled study.BMC musculoskeletal disorders · 2023Trial
- Increased inflammatory response is associated with less favorable functional results 5 years after total knee arthroplasty.Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA · 2023Trial
- Comparison of hypoallergenic knee arthroplasties in patients with metal hypersensitivity versus standard arthroplasties in non-hypersensitivity patients: A scoping review.Journal of orthopaedics · 2025Review
- Understanding immune-mediated cobalt/chromium allergy to orthopaedic implants: a meta-synthetic review.Arthroplasty (London, England) · 2024Review
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 at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn Germany, patients with contact allergy to implant components usually receive coated joint arthroplasties. Whether the treatment using these hypoallergenic implants achieves comparable results to standard treatment with implants consisting of cobalt-chromium alloy (CoCr) implants is controversially discussed internationally and has rarely been investigated in the mid-term.
objectivesAre there differences in blood metal ion concentrations, knee function, and patient-reported outcomes (PROM) between coated and standard implants? MATERIAL AND
methods118 patients were randomized to receive either a coated or a standard implant. Knee function as well as patient-reported outcome measures were assessed. Metal ion concentrations in blood samples were additionally determined for chromium, cobalt, molybdenum, and nickel, preoperatively, one and five years after surgery.
resultsAfter five years, it was possible to analyse the results of 97 patients. In metal ion concentrations, as well as PRO, consistently good results were seen, without any difference between the groups. While in 13 patients there was an increase in chromium concentration above 2 µg/l one year after surgery, there was no measured value above 1 µg/l after five years.
conclusionIn our study, similar mid-term results were detected for coated (TiNiN) and standard (CoCr)TKA. With respect to metal ion concentrations and PRO there are no disadvantages in using coated TKA.
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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.