Evidence map›Paper›PMID 35147719›Full record

Trial reportKnee surgery, sports traumatology, arthroscopy : official journal of the ESSKA2023

Increased inflammatory response is associated with less favorable functional results 5 years after total knee arthroplasty.

Jörg Lützner, Franziska Beyer, Cornelia Lützner, Peter Thomas, Burkhard Summer

Registry-linked trialOpen access · hybridFull text readRandomized Controlled Trial
In one paragraph

Trial report in Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00862511 (A Prospective Randomized Comparison of Serum Metal Ion Levels After Implantation of Coated and Uncoated Knee Prostheses), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 15% 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.

NCT00862511 nacompletednot on this map

A Prospective Randomized Comparison of Serum Metal Ion Levels After Implantation of Coated and Uncoated Knee Prostheses

TypeinterventionalSponsorTechnische Universität DresdenRan2009 to 2017Enrolled120ConditionsOsteoarthritis, Metal Ion LevelsArmsCoated Total Knee Arthroplasty, Standard Total Knee Arthroplasty
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
  5. Article
  6. 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

5 authors at 2 institutions in 1 country.

Jörg LütznerUniversity Center of Orthopaedic, Trauma and Plastic Surgery, University Hospital, TU Dresden, Fetscherst. 74, 01307, Dresden, Germany. Joerg.Luetzner@ukdd.de.ORCID http://orcid.org/0000-0002-7162-828X
Franziska BeyerUniversity Center of Orthopaedic, Trauma and Plastic Surgery, University Hospital, TU Dresden, Fetscherst. 74, 01307, Dresden, Germany.
Cornelia LütznerUniversity Center of Orthopaedic, Trauma and Plastic Surgery, University Hospital, TU Dresden, Fetscherst. 74, 01307, Dresden, Germany.
Peter ThomasDepartment of Dermatology und Allergology, Ludwig-Maximilias-University, Frauenlobstraße 9-11, 80337, Munich, Germany.
Burkhard SummerDepartment of Dermatology und Allergology, Ludwig-Maximilias-University, Frauenlobstraße 9-11, 80337, Munich, Germany.
Technische Universität Dresden · DELudwig-Maximilians-Universität München · DE

Funding

B Braun Aesculap MF MeIon
6 · The paper itself

Abstract

purposeAllergy against implant materials is discussed controversially and still not fully understood. Despite these controversies, a relevant number of patients receive hypoallergenic knee implants. The aim of this study was to compare a new coating system with the standard implant in total knee arthroplasty (TKA). Additionally, the influence of proinflammatory cytokines on patient-reported outcome measures (PROMs) was investigated.

methods120 patients without known metal allergy and without previous metal implants were included. The patients were randomized to receive a coated or standard TKA of the same knee system. 105 patients completed the 5 year follow-up. Patient-reported outcome measures (PROMs) including knee function (Oxford Knee Score, OKS), quality of life (SF36) and UCLA activity scale were assessed. Additionally, several cytokines with a possible role in implant allergy were measured in patient`s serum (IL-1beta, IL-5, IL-6, IL-8, IL-10, IP-10, IFN γ, TNF α). Group comparison was performed using Mann-Whitney U test for continuous values and chi-square test for categorical values.

resultsThere were no differences in PROMs between both groups at any follow-up. The majority of patients demonstrated no elevation of the measured blood cytokines. The blood cytokine pattern after 5 years demonstrated no differences between study groups. There was a significant association between elevated IL-8 values and worse results in the overall OKS (p = 0.041), the OKS function component (p = 0.004), the UCLA activity scale (p = 0.007) and the physical component of SF36 (p = 0.001).

conclusionThere were no problems with the new coating during mid-term follow-up and no differences in PROMs between coated and standard TKA. Patients with an increased inflammatory response demonstrated worse functional results, regardless of the implant. LEVEL OF EVIDENCE: I. CLINICAL

trial registrationThe study protocol was registered in the US National Institutes of Health's database ( http://www. CLINICALTRIALS: gov ) registry under NCT00862511.

Indexed as

Arthroplasty, Replacement, KneeHypersensitivityKnee ProsthesisOsteoarthritis, KneeCytokinesHumansInterleukin-8Knee JointPatient Reported Outcome MeasuresQuality of LifeTreatment OutcomeCytokinesInterleukin-8AllergyCoatingCytokinesHypersensibilityPatient-reported outcomeResultsTotal knee arthroplastyTotal knee replacement

Identifiers

PMID35147719
PMCPMC10049948
OpenAlexW4211180701

What OpenQuestion holds

Textfull text, public
LicenceCC BY
measurements read19
identifiers read1
Read underepoch 390

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.