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

doi:10.1186/s12891-023-07061-x

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

BMC Musculoskelet Disord. 2023 Dec 14;24(1):968. doi: 10.1186/s12891-023-07061-x.

Authors

Eric Tille¹, Franziska Beyer², Cornelia Lützner², Anne Postler², Peter Thomas³, Burkhard Summer³, Jörg Lützner²

Affiliations

¹ University Center of Orthopaedic, Trauma and Plastic Surgery, University Hospital Carl Gustav Carus, TU Dresden, Fetscherst. 74, 01307, Dresden, Germany. eric.tille@gmail.com.
² University Center of Orthopaedic, Trauma and Plastic Surgery, University Hospital Carl Gustav Carus, TU Dresden, Fetscherst. 74, 01307, Dresden, Germany.
³ Department of Dermatology und Allergology, Ludwig-Maximilians-University, Munich, Germany.

Abstract

Background: Allergies 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).

Methods: 76 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.

Results: There 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.

Conclusion: We 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 registration: The study protocol was registered in the US National Institutes of Health's database ( http://www.

Clinicaltrials: gov ) registry under NCT03424174 on 03/17/2016.

Keywords: Immunologic response; Metal hypersensitivity; Surface modification; Total knee arthroplasty.

Publication types

Randomized Controlled Trial

MeSH terms

Arthroplasty, Replacement, Knee* / adverse effects
Arthroplasty, Replacement, Knee* / methods
Cytokines
Humans
Hypersensitivity* / etiology
Hypersensitivity* / surgery
Knee Joint / surgery
Knee Prosthesis* / adverse effects
Osteoarthritis, Knee* / etiology
Osteoarthritis, Knee* / surgery
Patient Reported Outcome Measures
Quality of Life
Treatment Outcome

Substances

Cytokines

Associated data

ClinicalTrials.gov/NCT03424174