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.
Original language | English |
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Article number | 20958 |
Number of pages | 8 |
Journal | Scientific Reports |
Volume | 14 |
Issue number | 1 |
DOIs | |
Publication status | Published - 9 Sept 2024 |
Bibliographical note
© 2024. The Author(s).Keywords
- Humans
- Arthroplasty, Replacement, Knee/adverse effects
- Female
- Aged
- Male
- Follow-Up Studies
- Knee Prosthesis/adverse effects
- Middle Aged
- Prospective Studies
- Prosthesis Design
- Quality of Life
- Prosthesis Failure
- Ceramics
- Knee Joint/surgery
- Aged, 80 and over
- Postoperative Complications/etiology
- Metals/adverse effects
- Treatment Outcome
Fields of Science and Technology Classification 2012
- 501 Psychology