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Patient-specific instruments do not show advantage over conventional instruments in unicompartmental knee arthroplasty at 2 year follow-up: a prospective, two-centre, randomised, double-blind, controlled trial

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Knee Surgery, Sports Traumatology, Arthroscopy Aims and scope

Abstract

Purpose

The aim of this two-centre RCT was to compare pre- and post-operative radiological, clinical and functional outcomes between patient-specific instrumentation (PSI) and conventional instrumented (CI) unicompartmental knee arthroplasty (UKA). It was hypothesised that both alignment methods would have comparable post-operative radiological, clinical and functional outcomes.

Methods

One hundred and twenty patients were included, and randomly allocated to the PSI or the CI group. Outcome measures were peri-operative outcomes (operation time, length of hospital stay and intra-operative changes of implant size) and post-operative radiological outcomes including the alignment of the tibial and femoral component in the sagittal and frontal plane and the hip–knee–ankle-axis (HKA-axis), rate of adverse events (AEs) and patient-reported outcome measures (PROMs) pre-operatively and at 3, 12 and 24 months post-operatively.

Results

There was a statistically significant difference (p < 0.05) in alignment of the femoral component in the frontal plane in favour of the CI method. No statistically significant differences were found for the peri-operative data or in the functional outcome at 2-year follow-up. In the PSI group, the approved implant size of the femoral component was correct in 98.2% of the cases and the tibial component was correct in 60.7% of the cases. There was a comparable rate of AEs: 5.1% in the CI and 5.4% in the PSI group.

Conclusion

The PSI method did not show an advantage over CI in regard of positioning of the components, nor did it show an improvement in clinical or functional outcome. We conclude that the possible advantages of PSI do not outweigh the costs of the MRI scan and the manufacturing of the PSI.

Level of evidence

Randomised controlled trial, level I.

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Abbreviations

ACL:

Anterior cruciate ligament

AE:

Adverse event

AP:

Anterior–posterior

BMI:

Body mass index

CI:

Conventional instrumented

CT:

Computed tomography

EQ-5D-VAS:

EuroQuol-5D Visual Analogue Scale

FJS:

Forgotten Joint Score

HKA-axis:

Hip–knee–ankle-axis

ICD:

Implantable cardioverter-defibrillator

MRI:

Magnetic resonance imaging

NRS-pain:

Numeric Rating Scale for pain

OKS:

Oxford Knee Score

PROMs:

Patient-reported outcome measures

PSI:

Patient-specific instrumentation

RCT:

Randomised controlled trials

SD:

Standard deviation

TKA:

Total knee arthroplasty

UKA:

Unicompartmental knee arthroplasty

WOMAC:

Western Ontario and McMaster Universities Arthritis Index

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Acknowledgements

The authors would like to thank Ms Margreet Boevé, from the Amphia Hospital for her assistance in the data gathering, Ms Madelon Knijf for her collaboration on the radiologic evaluation and Ms Sharmila Thompson-Venkatesan, MD, and Mr Jan Truijen, MD, who served as external readers, and for their comments that greatly improved the manuscript.

Funding

The authors received no specific funding for this work.

Author information

Authors and Affiliations

  1. Department of Orthopaedics, Zuyderland Medical Centre, Dr. H. van der Hoffplein 1, 6162 BG, Sittard-Geleen, The Netherlands

    Alexandra M. Leenders, Jasper Most, Bert Boonen & Martijn G. M. Schotanus

  2. CortoClinics, Steeg 6E, 5482 WN, Schijndel, The Netherlands

    Nanne P. Kort

  3. Department of Orthopaedics, Amphia Hospital, Molengracht 21, 4814 CK, Breda, The Netherlands

    Koen L. M. Koenraadt & Rutger C. I. van Geenen

  4. Department of Orthopaedics, AZ Sint-Maarten, Liersesteenweg 435, 2800, Mechelen, Belgium

    Bart Kerens

  5. Department of Orthopaedics, VieCuri Medical Centre, Tegelseweg 210, 5912 BL, Venlo, The Netherlands

    Alexandra M. Leenders

  6. School of Care and Public Health Research Institute, Faculty of Health, Medicine and Life Sciences, Maastricht University Medical Centre, Universiteitssingel 40, 6229 ER, Maastricht, The Netherlands

    Martijn G. M. Schotanus

Authors
  1. Alexandra M. Leenders
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Contributions

AL gathered the data, wrote the initial draft of the manuscript and managed the study. MS designed the study and analysed the data, and revised the manuscript. JM analysed the data and revised the manuscript. NK, RG and BK conceived the study and revised the manuscript. KK and BB were involved in the drafting and revision of the manuscript.

Corresponding author

Correspondence to Alexandra M. Leenders.

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Conflict of interest

NK is a paid consultant for BodyCad, Bioventus, Stryker, Supportho Medical and Zimmer-Biomet. RG is a paid consultant for Zimmer-Biomet. The research foundation of the Amphia Hospital (RG and KK) receives funding from Zimmer-Biomet, Stryker and Mathys.

Ethical approval

This study was approved by the Independent Review Board (IRB, Zuyd Heerlen, the Netherlands; IRBNr. 12T92) and registered online at the Dutch Trial Register (www.trialregister.nl, Nr. NTR4278).

Informed consent

An informed consent was signed by all patients who were enrolled in this study.

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Leenders, A.M., Kort, N.P., Koenraadt, K.L.M. et al. Patient-specific instruments do not show advantage over conventional instruments in unicompartmental knee arthroplasty at 2 year follow-up: a prospective, two-centre, randomised, double-blind, controlled trial. Knee Surg Sports Traumatol Arthrosc 30, 918–927 (2022). https://doi.org/10.1007/s00167-021-06471-5

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