Similar outcome during short-term follow-up after coated and uncoated total knee arthroplasty: a randomized controlled study

  • Anne Postler
  • Franziska Beyer
  • Cornelia Lützner
  • Eric Tille
  • Jörg Lützner
Knee
  • 42 Downloads

Abstract

Purpose

Patients with known hypersensitivity to metals often require hypoallergenic TKA implants. Coating of a standard implant is a common solution, and although in vitro tests have demonstrated reduction of polyethylene wear for these coatings, it is still unknown whether these implants have any clinical benefit. This study was initiated to investigate metal ion concentrations, knee function and patient-reported outcome (PRO) after coated and uncoated TKA.

Methods

One hundred and twenty-two (122) patients were randomized to receive a coated or a standard TKA and, after exclusions, 59 patients were included in each group. Knee function and PRO were assessed with validated scores up to 3 years after surgery. Metal ion concentrations in blood samples were determined for chromium, cobalt, molybdenum and nickel, preoperatively and 1 year after surgery.

Results

Chromium concentrations in patient plasma increased from a median of 0.25 to 1.30 µg/l in the standard TKA group, and from 0.25 to 0.75 µg/l in the coated TKA group (p = 0.012). Thirteen patients (3 coated, 10 standard TKA) had chromium concentrations above 2 µg/l. The concentrations of cobalt, molybdenum and nickel did not change. Patient-reported outcome measures (PROM) demonstrated a substantial improvement after TKA, without any differences between the groups.

Conclusion

The increase in chromium concentration in the standard group needs further investigation. If surgeons use coated implants, they can be confident that these implants perform as well as standard implants.

Level of evidence

I.

Keywords

Total knee arthroplasty Total knee replacement Results Coated implant Allergy Metal hypersensitivity Metal ions 

Abbreviations

ASA

American Society of Anesthesiologists physical status classification

BMI

Body mass index

CoCrMo

Cobalt–chromium–molybdenum

CR

Cruciate retaining

GHP

General health perceptions index (SF-36)

HRQoL

Health-related quality of life

ISO

International Organization for Standardization

LOS

Length of hospital stay

MHI

Mental health index (SF-36)

MoM

Metal-on-metal

n.s.

Not significant

OKS

Oxford Knee Score

PAIN

Bodily pain index (SF-36)

PFI

Physical function index (SF-36)

PRO

Patient-reported outcome

PVD

Physical vapor deposition method

ROLEM

Role-emotional index (SF-36)

ROLPH

Role physical index (SF-36)

SD

Standard deviation

SF 36

Short Form 36

SOCIAL

Social functioning index (SF-36)

TiNbN

Titanium–niobium–nitride

TKA

Total knee arthroplasty

UCLA

University of Los Angeles

UHMWPE

Ultrahigh-molecular-weight polyethylene insert

VITAL

Vitality index (SF-36)

vs

Versus

Notes

Acknowledgements

This study was supported by a research grant from Mathys AG (Bettlach, Switzerland). The authors thank Brit Brethfeld and Anne Schützer for their valuable assistance during follow-up and data management and Gary Jennings for language editing.

Authors’ contributions

JL designed the study, all authors were involved in study implementation, CL and FB performed data management and statistical analysis, AP wrote the first draft, and all authors contributed to and approved the final manuscript.

Compliance with ethical standards

Conflict of interest

Prof. Lützner has received payments for lectures from Aesculap and Mathys, all other authors declare no conflict of interest.

Ethical approval

The study was performed in compliance with the Helsinki Declaration and is registered at ClinicalTrials.gov (NCT03047564). Institutional review board approval was granted from TU Dresden (EK 339092011).

Informed consent

All patients signed informed consent.

References

  1. 1.
    Carr AJ, Robertsson O, Graves S, Price AJ, Arden NK, Judge A et al (2012) Knee replacement. Lancet 379:1331–1340CrossRefPubMedGoogle Scholar
  2. 2.
    Cadosch D, Chan E, Gautschi OP, Filgueira L (2009) Metal is not inert: role of metal ions released by biocorrosion in aseptic loosening—current concepts. J Biomed Mater Res A 91:1252–1262CrossRefPubMedGoogle Scholar
  3. 3.
    Tharani R, Dorey FJ, Schmalzried TP (2001) The risk of cancer following total hip or knee arthroplasty. J Bone Jt Surg Am 83-A:774–780CrossRefGoogle Scholar
  4. 4.
    Whittingham-Jones PM, Dunstan E, Altaf H, Cannon SR, Revell PA, Briggs TW (2008) Immune responses in patients with metal-on-metal hip articulations: a long-term follow-up. J Arthroplasty 23:1212–1218CrossRefPubMedGoogle Scholar
  5. 5.
    Basko-Plluska JL, Thyssen JP, Schalock PC (2011) Cutaneous and systemic hypersensitivity reactions to metallic implants. Dermatitis 22:65–79PubMedGoogle Scholar
  6. 6.
    Granchi D, Cenni E, Tigani D, Trisolino G, Baldini N, Giunti A (2008) Sensitivity to implant materials in patients with total knee arthroplasties. Biomaterials 29:1494–1500CrossRefPubMedGoogle Scholar
  7. 7.
    Niki Y, Matsumoto H, Otani T, Yatabe T, Kondo M, Yoshimine F et al (2005) Screening for symptomatic metal sensitivity: a prospective study of 92 patients undergoing total knee arthroplasty. Biomaterials 26:1019–1026CrossRefPubMedGoogle Scholar
  8. 8.
    Lützner J, Krummenauer F, Lengel AM, Ziegler J, Witzleb WC (2007) Serum metal ion exposure after total knee arthroplasty. Clin Orthop Relat Res 461:136–142Google Scholar
  9. 9.
    Frigerio E, Pigatto PD, Guzzi G, Altomare G (2011) Metal sensitivity in patients with orthopaedic implants: a prospective study. Contact Dermat 64:273–279CrossRefGoogle Scholar
  10. 10.
    Granchi D, Cenni E, Giunti A, Baldini N (2012) Metal hypersensitivity testing in patients undergoing joint replacement: a systematic review. J Bone Jt Surg Br 94:1126–1134CrossRefGoogle Scholar
  11. 11.
    Middleton S, Toms A (2016) Allergy in total knee arthroplasty: a review of the facts. Bone Jt J 98-B:437–441CrossRefGoogle Scholar
  12. 12.
    Schafer T, Bohler E, Ruhdorfer S, Weigl L, Wessner D, Filipiak B et al (2001) Epidemiology of contact allergy in adults. Allergy 56:1192–1196CrossRefPubMedGoogle Scholar
  13. 13.
    Thomas P, Schuh A, Ring J, Thomsen M (2008) [Orthopedic surgical implants and allergies: joint statement by the implant allergy working group (AK 20) of the DGOOC (German association of orthopedics and orthopedic surgery), DKG (German contact dermatitis research group) and dgaki (German society for allergology and clinical immunology)]. Orthopade 37:75–88CrossRefPubMedGoogle Scholar
  14. 14.
    Bal BS, Garino J, Ries M, Oonishi H (2007) Ceramic bearings in total knee arthroplasty. J Knee Surg 20:261–270CrossRefPubMedGoogle Scholar
  15. 15.
    Bergschmidt P, Bader R, Ganzer D, Hauzeur C, Lohmann C, Ruther W et al (2012) Ceramic femoral components in total knee arthroplasty - two year follow-up results of an international prospective multi-centre study. Open Orthop J 6:172–178CrossRefPubMedPubMedCentralGoogle Scholar
  16. 16.
    Kluess D, Bergschmidt P, Mueller I, Mittelmeier W, Bader R (2012) Influence of the distal femoral resection angle on the principal stresses in ceramic total knee components. Knee 19:846–850CrossRefPubMedGoogle Scholar
  17. 17.
    Kluess D, Mittelmeier W, Bader R (2010) Intraoperative impaction of total knee replacements: an explicit finite-element-analysis of principal stresses in ceramic vs. cobalt-chromium femoral components. Clin Biomech (Bristol Avon) 25:1018–1024CrossRefGoogle Scholar
  18. 18.
    Ezzet KA, Hermida JC, Colwell CW Jr, D’Lima DD (2004) Oxidized zirconium femoral components reduce polyethylene wear in a knee wear simulator. Clin Orthop Relat Res 428:120–124CrossRefGoogle Scholar
  19. 19.
    Ezzet KA, Hermida JC, Steklov N, DD DL (2012) Wear of polyethylene against oxidized zirconium femoral components effect of aggressive kinematic conditions and malalignment in total knee arthroplasty. J Arthroplasty 27:116–121CrossRefPubMedGoogle Scholar
  20. 20.
    Fabry C, Zietz C, Baumann A, Bader R (2015) Wear performance of sequentially cross-linked polyethylene inserts against ion-treated CoCr, TiNbN-coated CoCr and Al2O3 ceramic femoral heads for total hip replacement. Lubricants 3:14–26CrossRefGoogle Scholar
  21. 21.
    Oonishi H, Ueno M, Kim SC, Oonishi H, Iwamoto M, Kyomoto M (2009) Ceramic versus cobalt-chrome femoral components; wear of polyethylene insert in total knee prosthesis. J Arthroplasty 24:374–382CrossRefPubMedGoogle Scholar
  22. 22.
    Reich J, Thomas P, Hovy L, Lindemaier HL, Zeller R, Schwiesau J (2007) Allergy solutions for orthopaedic Knee-Implants. Biomaterialien 8:109–110Google Scholar
  23. 23.
    Hallab NJ, Jacobs JJ (2009) Biologic effects of implant debris. Bull NYU Hosp Jt Dis 67:182–188PubMedGoogle Scholar
  24. 24.
    Vertullo CJ, Lewis PL, Graves S, Kelly L, Lorimer M, Myers P (2017) Twelve-Year Outcomes of an Oxinium Total Knee Replacement Compared with the Same Cobalt-Chromium Design: An Analysis of 17,577 Prostheses from the Australian Orthopaedic Association National Joint Replacement Registry. J Bone Jt Surg Am 99:275–283CrossRefGoogle Scholar
  25. 25.
    Hannemann F, Hartmann A, Schmitt J, Lutzner J, Seidler A, Campbell P et al (2013) European multidisciplinary consensus statement on the use and monitoring of metal-on-metal bearings for total hip replacement and hip resurfacing. Orthop Traumatol Surg Res 99:263–271CrossRefPubMedGoogle Scholar
  26. 26.
    Lützner J, Hartmann A, Dinnebier G, Spornraft-Ragaller P, Hamann C, Kirschner S (2013) Metal hypersensitivity and metal ion levels in patients with coated or uncoated total knee arthroplasty: a randomised controlled study. Int Orthop 37:1925–1931CrossRefPubMedPubMedCentralGoogle Scholar
  27. 27.
    Lainiala OS, Moilanen TP, Hart AJ, Huhtala HS, Sabah SA, Eskelinen AP (2016) Higher Blood Cobalt and Chromium Levels in Patients With Unilateral Metal-on-Metal Total Hip Arthroplasties Compared to Hip Resurfacings. J Arthroplasty 31:1261–1266CrossRefPubMedGoogle Scholar
  28. 28.
    van der Veen HC, Reininga IH, Zijlstra WP, Boomsma MF, Bulstra SK, van Raay JJ (2015) Pseudotumour incidence, cobalt levels and clinical outcome after large head metal-on-metal and conventional metal-on-polyethylene total hip arthroplasty: mid-term results of a randomised controlled trial. Bone Jt J 97-B:1481–1487CrossRefGoogle Scholar
  29. 29.
    Vendittoli PA, Mottard S, Roy AG, Dupont C, Lavigne M (2007) Chromium and cobalt ion release following the Durom high carbon content, forged metal-on-metal surface replacement of the hip. J Bone Jt Surg Br 89:441–448CrossRefGoogle Scholar
  30. 30.
    Vassiliou K, Elfick AP, Scholes SC, Unsworth A (2006) The effect of ‘running-in’ on the tribology and surface morphology of metal-on-metal Birmingham hip resurfacing device in simulator studies. Proc Inst Mech Eng H 220:269–277CrossRefPubMedGoogle Scholar
  31. 31.
    Friesenbichler J, Maurer-Ertl W, Sadoghi P, Lovse T, Windhager R, Leithner A (2012) Serum metal ion levels after rotating-hinge knee arthroplasty: comparison between a standard device and a megaprosthesis. Int Orthop 36:539–544CrossRefPubMedGoogle Scholar
  32. 32.
    Bravo D, Wagner ER, Larson DR, Davis MP, Pagnano MW, Sierra RJ (2016) no increased risk of knee arthroplasty failure in patients with positive skin patch testing for metal hypersensitivity: a matched cohort study. J Arthroplasty 31:1717–1721CrossRefPubMedGoogle Scholar
  33. 33.
    Reich J, Hovy L, Lindenmaier HL, Zeller R, Schwiesau J, Thomas P et al (2010) Preclinical evaluation of coated knee implants for allergic patients. Orthopade 39:495–502CrossRefPubMedGoogle Scholar
  34. 34.
    Spector BM, Ries MD, Bourne RB, Sauer WS, Long M, Hunter G (2001) Wear performance of ultra-high molecular weight polyethylene on oxidized zirconium total knee femoral components. J Bone Jt Surg Am 83-A Suppl 2 Pt 2:80–86CrossRefGoogle Scholar
  35. 35.
    Tsukamoto R, Chen S, Asano T, Ogino M, Shoji H, Nakamura T et al (2006) Improved wear performance with crosslinked UHMWPE and zirconia implants in knee simulation. Acta Orthop 77:505–511CrossRefPubMedGoogle Scholar
  36. 36.
    National Joint Registry (2017) 14th Annual Report 2017. National Joint Registry for England, Wales, Northern Ireland and the Isle of Man. http://www.njrreports.org.uk/Portals/0/PDFdownloads/NJR%2014th%20Annual%20Report%202017.pdf
  37. 37.
    Beyer F, Lutzner C, Kirschner S, Lutzner J (2016) Midterm Results After Coated and Uncoated TKA: A Randomized Controlled Study. Orthopedics 39:S13-S17CrossRefGoogle Scholar
  38. 38.
    Garrett S, Jacobs N, Yates P, Smith A, Wood D (2010) Differences in metal ion release following cobalt-chromium and oxidized zirconium total knee arthroplasty. Acta Orthop Belg 76:513–520PubMedGoogle Scholar
  39. 39.
    Gobel F, Ulbricht S, Hein W, Bernstein A (2008) [Radiological mid-term results of total knee arthroplasty with femoral components of different materials]. Z Orthop Unfall 146:194–199CrossRefPubMedGoogle Scholar
  40. 40.
    van Hove RP, Brohet RM, van Royen BJ, Nolte PA (2015) No clinical benefit of titanium nitride coating in cementless mobile-bearing total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc 23:1833–1840CrossRefPubMedGoogle Scholar
  41. 41.
    Hartmann A, Kieback JD, Lutzner J, Gunther KP, Goronzy J (2017) Adverse reaction to metal debris in a consecutive series of DUROM hip resurfacing: pseudotumour incidence and metal ion concentration. Hip Int 27:343–348CrossRefPubMedGoogle Scholar

Copyright information

© European Society of Sports Traumatology, Knee Surgery, Arthroscopy (ESSKA) 2018

Authors and Affiliations

  1. 1.University Center of Orthopaedics and TraumatologyUniversity Medicine Carl Gustav Carus DresdenDresdenGermany

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