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

  • Knee
  • Published:
Knee Surgery, Sports Traumatology, Arthroscopy Aims and scope

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.

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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

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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.

Funding

This project was supported by a research grant from Mathys.

Author information

Authors and Affiliations

  1. University Center of Orthopaedics and Traumatology, University Medicine Carl Gustav Carus Dresden, Fetscherstr. 74, 01307, Dresden, Germany

    Anne Postler, Franziska Beyer, Cornelia Lützner, Eric Tille & Jörg Lützner

Authors
  1. Anne Postler
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  2. Franziska Beyer
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  3. Cornelia Lützner
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  4. Eric Tille
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  5. Jörg Lützner
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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.

Corresponding author

Correspondence to Jörg Lützner.

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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.

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Postler, A., Beyer, F., Lützner, C. et al. Similar outcome during short-term follow-up after coated and uncoated total knee arthroplasty: a randomized controlled study. Knee Surg Sports Traumatol Arthrosc 26, 3459–3467 (2018). https://doi.org/10.1007/s00167-018-4928-0

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  • DOI: https://doi.org/10.1007/s00167-018-4928-0

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