Long term follow-up of a completely metal free total knee endoprosthesis in comparison to an identical metal counterpart.
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
Journal
Scientific reports
ISSN: 2045-2322
Titre abrégé: Sci Rep
Pays: England
ID NLM: 101563288
Informations de publication
Date de publication:
09 09 2024
09 09 2024
Historique:
received:
18
01
2024
accepted:
26
08
2024
medline:
10
9
2024
pubmed:
10
9
2024
entrez:
9
9
2024
Statut:
epublish
Résumé
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.
Identifiants
pubmed: 39251687
doi: 10.1038/s41598-024-71256-y
pii: 10.1038/s41598-024-71256-y
doi:
Substances chimiques
Metals
0
Types de publication
Journal Article
Observational Study
Comparative Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
20958Informations de copyright
© 2024. The Author(s).
Références
Lachiewicz, P. F., Watters, T. S. & Jacobs, J. J. Metal hypersensitivity and total knee arthroplasty. J. Am. Acad. Orthop. Surg. 24, 106–112 (2016).
doi: 10.5435/JAAOS-D-14-00290
pubmed: 26752739
pmcid: 4726476
Reiner, T. et al. Blood metal ion release after primary total knee arthroplasty: A prospective study. Orthop. Surg. 12, 396–403 (2020).
doi: 10.1111/os.12591
pubmed: 32023362
pmcid: 7189061
Lützner, J., Dinnebier, G., Hartmann, A., Günther, K. & Kirschner, S. Study rationale and protocol: prospective randomized comparison of metal ion concentrations in the patient’s plasma after implantation of coated and uncoated total knee prostheses. BMC Musculoskelet. Disord. 10, 1–6 (2009).
doi: 10.1186/1471-2474-10-128
Hallab, N. & Jacobs, J. Biologic effects of implant debris. Bull. NYU Hosp. Jt. Dis. 67, 182–188 (2009).
pubmed: 19583551
Möller, H. Nickel dermatitis: Problems solved and unsolved. Contact Dermatitis. 23, 217–220 (1990).
doi: 10.1111/j.1600-0536.1990.tb05001.x
pubmed: 2073779
Akil, S. et al. Metal hypersensitivity in total hip and knee arthroplasty: Current concepts. J. Clin. Orthop. Trauma 9, 3–6. https://doi.org/10.1016/j.jcot.2017.10.003 (2018).
doi: 10.1016/j.jcot.2017.10.003
pubmed: 29628676
Hallab, N., Merritt, K. & Jacobs, J. J. Metal sensitivity in patients with orthopaedic implants. J. Bone Jt. Surg. 83, 428–436 (2001).
doi: 10.2106/00004623-200103000-00017
Granchi, D., Cenni, E., Giunti, A. & Baldini, N. Metal hypersensitivity testing in patients undergoing joint replacement. J. Bone Jt. Surg. Br. 94-B, 1126–1134 (2012).
doi: 10.1302/0301-620X.94B8.28135
Teo, W. Z. W. & Schalock, P. C. Metal hypersensitivity reactions to orthopedic implants. Dermatol. Ther. (Heidelb). 7, 53–64 (2017).
doi: 10.1007/s13555-016-0162-1
pubmed: 27995484
Villano, M., Carulli, C., Puccini, S., Soderi, S. & Innocenti, M. Painful knee prosthesis: Surgical approach. Clin. Cases Miner. Bone Metab. 8, 26–28 (2011).
pubmed: 22461812
pmcid: 3279078
Pacheco, K. A. Allergy to surgical implants. Clin. Rev. Allergy Immunol. 56, 72–85 (2019).
doi: 10.1007/s12016-018-8707-y
pubmed: 30220068
Meier, E. et al. First clinical study of a novel complete metal-free ceramic total knee replacement system. J. Orthop. Surg. Res. 11, 1–7. https://doi.org/10.1186/s13018-016-0352-7 (2016).
doi: 10.1186/s13018-016-0352-7
Stadler, N., Lehner, J. & Trieb, K. Prospective mid-term results of a consecutive series of a short stem. Acta Orthop. Belg. 82, 372–375 (2016).
pubmed: 27682302
Ezzet, K. A., Hermida, J. C., Colwell, C. W. & D’Lima, D. D. Oxidized zirconium femoral components reduce polyethylene wear in a knee wear simulator. Clin. Orthop. Relat. Res. 428, 120–124 (2004).
doi: 10.1097/01.blo.0000148576.70780.13
Oonishi, H. et al. Ceramic versus cobalt-chrome femoral components; wear of polyethylene insert in total knee prosthesis. J. Arthroplasty. 24, 374–382. https://doi.org/10.1016/j.arth.2007.10.021 (2009).
doi: 10.1016/j.arth.2007.10.021
pubmed: 18524533
Trieb, K. A novel ceramic tibial component is as safe as its metal counterpart. Biomed. Tech. 63, 327–332 (2017).
doi: 10.1515/bmt-2016-0231
Breuer, R., Fiala, R., Trieb, K. & Rath, B. Prospective mid-term results of a completely metal-free ceramic total knee endoprosthesis: A concise follow-up of a previous report. J. Arthroplasty. 36, 3161–3167. https://doi.org/10.1016/j.arth.2021.05.007 (2021).
doi: 10.1016/j.arth.2021.05.007
pubmed: 34090690
McGrory, J. E., Trousdale, R. T., Pagnano, M. W. & Nigbur, M. Preoperative hip to ankle radiographs in total knee arthroplasty. Clin. Orthop. Relat. Res. 404, 196–202 (2002).
doi: 10.1097/00003086-200211000-00032
Insall, J. N., Dorr, D., Scott, R. & Scott, W. Rationale of the knee society clinical rating system. Clin. Orthop. Relat. Res. 26, 13–14 (1989).
Murray, D. W. et al. The use of the Oxford hip and knee scores. J. Bone Jt. Surg. Ser. B 89, 1010–1014 (2007).
doi: 10.1302/0301-620X.89B8.19424
Herdmann, M. et al. Development and preliminary testing of the new five-level version of EQ-5D ( EQ-5D-5L ). Qual. Life Res. 20, 1727–1736 (2011).
doi: 10.1007/s11136-011-9903-x
Vogel, N., Kaelin, R., Rychen, T. & Arnold, M. P. The German version of the high-activity arthroplasty score is valid and reliable for patients after total knee arthroplasty. Knee Surg. Sport Traumatol. Arthrosc. 30, 1204–1211. https://doi.org/10.1007/s00167-021-06531-w (2022).
doi: 10.1007/s00167-021-06531-w
Ewald, F. C. The knee society total knee arthroplasty roentgenographic evaluation and scoring system. Clin. Orthop. Relat. Res. 248, 9–12 (1989).
doi: 10.1097/00003086-198911000-00003
Ahlström, M. G., Thyssen, J. P., Wennervaldt, M., Menné, T. & Johansen, J. D. Nickel allergy and allergic contact dermatitis: A clinical review of immunology, epidemiology, exposure, and treatment. Contact Dermatitis. 81, 227–241 (2019).
doi: 10.1111/cod.13327
pubmed: 31140194
Thyssen, J. P. & Menné, T. Metal allergys—A review on exposures, penetration, genetics, prevalence, and clinical implications. Chem. Res. Toxicol. 23, 309–318 (2010).
doi: 10.1021/tx9002726
pubmed: 19831422
Granchi, D. et al. Sensitivity to implant materials in patients with total knee arthroplasties. Biomaterials. 29, 1494–1500 (2008).
doi: 10.1016/j.biomaterials.2007.11.038
pubmed: 18155140
Xiang, S., Zhao, Y., Li, Z., Feng, B. & Weng, X. Clinical outcomes of ceramic femoral prosthesis in total knee arthroplasty: A systematic review 11 Medical and Health Sciences 1103 Clinical Sciences. J. Orthop. Surg. Res. 14, 1–10 (2019).
Banci, L., Balato, G., Salari, P. & Baldini, A. Systematic review and meta-analysis of ceramic coated implants in total knee arthroplasty. Comparable mid-term results to uncoated implants. Knee Surg. Sport Traumatol. Arthrosc. 31, 839–851. https://doi.org/10.1007/s00167-021-06775-6 (2023).
doi: 10.1007/s00167-021-06775-6
Kim, Y. H., Park, J. W. & Kim, J. S. The 2018 Mark Coventry, MD Award: Does a ceramic bearing improve pain, function, wear, or survivorship of TKA in patients younger than 55 years of age? A randomized trial. Clin. Orthop. Relat. Res. 477, 49–57 (2019).
doi: 10.1007/s11999.0000000000000271
pubmed: 30794228
Guha, A. R., Debnath, U. K. & Graham, N. M. K. Radiolucent lines below the tibial component of a total knee replacement (TKR)—A comparison between single-and two-stage cementation techniques. Int. Orthop. 32, 453–457 (2008).
doi: 10.1007/s00264-007-0345-6
pubmed: 17364179
O’Donovan, P., McAleese, T. & Harty, J. Does lucency equate to revision? A five-year retrospective review of Attune and Triathlon total knee arthroplasty. Knee Surg. Sport Traumatol. Arthrosc. https://doi.org/10.1007/s00167-023-07509-6 (2023).
doi: 10.1007/s00167-023-07509-6
Heesterbeek, P. J. C. et al. Superior long-term survival for fixed bearing compared with mobile bearing in ligament-balanced total knee arthroplasty. Knee Surg. Sport Traumatol. Arthrosc. 26, 1524–1531 (2018).
doi: 10.1007/s00167-017-4542-6
Kim, Y. H., Park, J. W. & Kim, J. S. Comparison of high-flexion fixed-bearing and high-flexion mobile-bearing total knee arthroplasties—A prospective randomized study. J. Arthroplasty 33, 130–135. https://doi.org/10.1016/j.arth.2017.07.025 (2018).
doi: 10.1016/j.arth.2017.07.025
pubmed: 28844767
Williams, D. P. et al. Long-term trends in the Oxford knee score following total knee replacement. J. Bone Jt. Surg. Ser. B 95, 45–51 (2013).
doi: 10.1302/0301-620X.95B1.28573
Bercovy, M., Kerboull, L., Müller, J. H., Saffarini, M. & Sailhan, F. Satisfactory mid- to long-term outcomes of TKA aligned using conventional instrumentation for flexion gap balancing with minimal soft tissue release. Knee Surg. Sport Traumatol. Arthrosc. 30, 627–637. https://doi.org/10.1007/s00167-020-06360-3 (2022).
doi: 10.1007/s00167-020-06360-3
Schneider, B. L., Ling, D. I., Kleebad, L. J., Strickland, S. & Pearle, A. Comparing return to sports after patellofemoral and knee arthroplasty in an age- and sex-matched cohort. Orthop. J. Sports Med. 8, 1–7 (2020).
doi: 10.1177/2325967120957425
Talbot, S., Hooper, G., Stokes, A. & Zordan, R. Use of a new high-activity arthroplasty score to assess function of young patients with total hip or knee arthroplasty. J. Arthroplasty. 25, 268–273. https://doi.org/10.1016/j.arth.2008.09.019 (2010).
doi: 10.1016/j.arth.2008.09.019
pubmed: 19056232
Rossi, S. M. P., Perticarini, L., Mosconi, M., Ghiara, M. & Benazzo, F. Ten-year outcomes of a nitrided Ti-6Al-4V titanium alloy fixed-bearing total knee replacement with a highly crosslinked polyethylene-bearing in patients with metal allergy. Knee. 27, 1519–1524. https://doi.org/10.1016/j.knee.2020.08.007 (2020).
doi: 10.1016/j.knee.2020.08.007
pubmed: 33010769