Observational studyScientific reports2024
Long term follow-up of a completely metal free total knee endoprosthesis in comparison to an identical metal counterpart.
Observational study in Scientific reports, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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8 authors.
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Abstract
Aseptic loosening is a feared and not yet fully-understood complication of total knee arthroplasty (TKA). Hypersensitivity reactions may be the underlying cause within some susceptible patients. Metal-free implants have been developed as a possible solution. The aim of this prospective, observational long-term study was the assessment of a completely metal-free ceramic knee replacement system compared to its identical metal counterpart 8 years after implantation, conducted as a follow-up of a previous report. A total of 88 patients (mean age 69 years) were enrolled in this prospective, observational long-term 8-year follow-up study. The "ceramic group" with a completely metal-free total knee replacement system was compared to the "conventional group" with an identical metal TKA system at the final follow-up. Clinical assessment included Knee Society Score (KSS), Oxford Knee Score (OKS), European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-L), European Quality of Life 5 Dimension Visual Analogue Scale (EQ-VAS) and High Activity Arthroplasty Score (HAAS) as well as perioperative or postoperative complications and need for revision. The tibial/femoral positioning, signs of periprosthetic fissures/fractures or radiolucent lines were documented radiographically. All postoperative clinical scores in the ceramic group primarily improved from baseline to 4-year follow-up, but then decreased at the final 8-year follow-up. At the final follow-up, statistically non-significant differences were found in comparison of both groups for the KSS (ceramic: 166 ± 31, conventional: 162 ± 29; p > 0.05), OKS (ceramic: 37, conventional: 39; p > 0.05), EQ-VAS (ceramic: 77 ± 17, conventional: 72 ± 18; p > 0.05), and HAAS (ceramic: 8.29 ± 3.32, conventional: 9.28 ± 4.44; p > 0.05). A significant difference was found for EQ-5D-L (ceramic: 0.819 ± 0.284, conventional: 0.932 ± 0.126; p ≤ 0.05). Progressive radiolucent lines have been found around the uncemented tibial stem (0.8 mm at initial diagnosis (mean 19 months); 1.3 mm at 4-year follow-up; 1.6 mm at 8-year follow-up) without any clinical signs of loosening. One revision surgery was performed after a traumatic polyethylene inlay-breakage. No allergic reactions could be detected. The used ceramic TKA system meets the functional performance standards of an established identical metal TKA system after an 8-year follow-up period, offering a safe option for patients with prior hypersensitivity reactions to metallic materials. Full cementation of ceramic components is recommended.
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