Abstract | PURPOSE:
Allergy 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. METHODS: 120 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. RESULTS: There 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). CONCLUSION: There 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 REGISTRATION: The study protocol was registered in the US National Institutes of Health's database ( http://www. CLINICALTRIALS: gov ) registry under NCT00862511.
|
Authors | Jörg Lützner, Franziska Beyer, Cornelia Lützner, Peter Thomas, Burkhard Summer |
Journal | Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA
(Knee Surg Sports Traumatol Arthrosc)
Vol. 31
Issue 4
Pg. 1316-1322
(Apr 2023)
ISSN: 1433-7347 [Electronic] Germany |
PMID | 35147719
(Publication Type: Randomized Controlled Trial, Journal Article)
|
Copyright | © 2022. The Author(s). |
Chemical References |
|
Topics |
- Humans
- Arthroplasty, Replacement, Knee
(adverse effects, methods)
- Quality of Life
- Interleukin-8
- Knee Prosthesis
(adverse effects)
- Knee Joint
(surgery)
- Osteoarthritis, Knee
- Hypersensitivity
(etiology)
- Cytokines
- Treatment Outcome
- Patient Reported Outcome Measures
|