Evidence map›Paper›PMID 38098024›Full record

Trial reportBMC musculoskeletal disorders2023

No difference in patient reported outcome and inflammatory response after coated and uncoated total knee arthroplasty - a randomized controlled study.

Eric Tille, Franziska Beyer, Cornelia Lützner, Anne Postler, Peter Thomas, Burkhard Summer, Jörg Lützner

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC musculoskeletal disorders, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03424174 (Clinical Outcome and Cytokine Expression in Blood After Coated in Comparison to Uncoated TKA), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT03424174 naactive not recruitingnot on this map

Clinical Outcome and Cytokine Expression in Blood After Coated in Comparison to Uncoated TKA

TypeinterventionalSponsorTechnische Universität DresdenRan2017 to 2028Enrolled80ConditionsOsteoarthritisArmsCoated Total Knee Arthroplasty, Standard Total Knee Arthroplasty
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
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

7 authors.

Eric TilleUniversity Center of Orthopaedic, Trauma and Plastic Surgery, University Hospital Carl Gustav Carus, TU Dresden, Fetscherst. 74, 01307, Dresden, Germany. eric.tille@gmail.com.
Franziska BeyerUniversity Center of Orthopaedic, Trauma and Plastic Surgery, University Hospital Carl Gustav Carus, TU Dresden, Fetscherst. 74, 01307, Dresden, Germany.
Cornelia LütznerUniversity Center of Orthopaedic, Trauma and Plastic Surgery, University Hospital Carl Gustav Carus, TU Dresden, Fetscherst. 74, 01307, Dresden, Germany.
Anne PostlerUniversity Center of Orthopaedic, Trauma and Plastic Surgery, University Hospital Carl Gustav Carus, TU Dresden, Fetscherst. 74, 01307, Dresden, Germany.
Peter ThomasDepartment of Dermatology und Allergology, Ludwig-Maximilians-University, Munich, Germany.
Burkhard SummerDepartment of Dermatology und Allergology, Ludwig-Maximilians-University, Munich, Germany.
Jörg LütznerUniversity Center of Orthopaedic, Trauma and Plastic Surgery, University Hospital Carl Gustav Carus, TU Dresden, Fetscherst. 74, 01307, Dresden, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAllergies against implant materials are still not fully understood. Despite controversies about its relevance, some patients need treatment with hypoallergenic implants. This study compared coated and standard total knee arthroplasty (TKA) regarding inflammatory response and patient-reported outcome measures (PROMs).

methods76 patients without self-reported allergies against implant materials were included in a RCT and received a coated or standard TKA of the same cemented posterior-stabilized knee system. 73 patients completed the 3-year follow-up. Two patients died and there was one revision surgery. Serum levels of cytokines with a possible role in implant allergy were measured in patient`s serum (IL-1beta, IL-5, IL-6, IL-8, IL-10, IFN γ, TNF α) prior to, one and three years after surgery. Furthermore, PROMs including knee function (Oxford Knee Score, Knee Society Score) and health-related quality of life (QoL, EuroQuol questionnaire) were assessed. Additionally, 8 patients with patch-test proven skin allergy against implant materials who received the coated implant were assessed similarly and compared to a matched-pair group receiving the same implant.

resultsThere were no differences in function and QoL between the assessed groups at any follow-up. The majority of patients demonstrated no elevation of the measured blood cytokines. Cytokine patterns showed no differences between study groups at any follow-up. The allergy patients demonstrated slower functional improvement and minor differences in cytokine pattern. Yet these results were not significant. There were no differences in the matched-pair analysis.

conclusionWe observed no relevant increase in serum cytokine levels in any group. The inflammatory response measured seems limited, even in allergy patients. Furthermore, there were no differences between coated and standard TKA in non-allergy patients in the 3-year Follow-Up period.

trial registrationThe study protocol was registered in the US National Institutes of Health's database ( http://www. CLINICALTRIALS: gov ) registry under NCT03424174 on 03/17/2016.

Indexed as

Arthroplasty, Replacement, KneeHypersensitivityKnee ProsthesisOsteoarthritis, KneeCytokinesHumansKnee JointPatient Reported Outcome MeasuresQuality of LifeTreatment OutcomeCytokinesImmunologic responseMetal hypersensitivitySurface modificationTotal knee arthroplasty

Identifiers

PMID38098024
PMCPMC10720193

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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.