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No difference in mid-term survival and clinical outcome between patient-specific and conventional instrumented total knee arthroplasty: a randomized controlled trial

  • M. G. M. Schotanus
  • B. Boonen
  • W. van der Weegen
  • H. Hoekstra
  • R. van Drumpt
  • R. Borghans
  • R. Vos
  • L. van Rhijn
  • N. P. Kort
Knee
  • 76 Downloads

Abstract

Purpose

The purpose of this multicentre prospective randomized controlled trial was to compare the survival rate and clinical outcome in total knee arthroplasty (TKA) after MRI-based patient-specific instruments (PSI) and conventional instruments 5 years after initial surgery.

Methods

At a mean follow-up of 5.1 years (0.4), 163 patients (90.6%) with a mean age of 71.8 years (8.7) were analysed. A survival analysis with revision of the TKA as endpoint was performed. The Knee Society Score (KSS), evaluations on plain radiographs and patient-reported outcome measures (PROMs) were obtained preoperatively and at each FU.

Results

At final follow-up, one TKA in the PSI- (1.2%) and 3 TKAs in the conventional group (3.8%) had undergone revision surgery (n.s.). No radiological abnormalities were noted at any time point. Postoperatively, the KSS and PROMs significantly improved within each group compared with the preoperative values. There were no clinically relevant differences for the KSS [PSI: 77.4, 9.8 (95% CI 75.0–79.7) vs. conventional: 77.3 10.5 (95% CI 74.9–79.8)] and the PROMs between both groups (n.s.) at 5 years follow-up.

Conclusion

There is still a lack of reliable data on the survival of TKA and clinical evidence, when using PSI for TKA. Longer follow-up studies are, therefore, needed.

Level of evidence

I.

Keywords

Patient-specific instruments Conventional instruments Total knee arthroplasty Mid-term Survival Randomized controlled trial PROMS TKA RCT PSI 

Notes

Author contributions

MGMS: Designed the study, gathered and analysed all the data, wrote the initial draft of the manuscript and managed the study. BB: Ensured the accuracy of the data and the analysis, wrote and revised the manuscript. WW: Gathered and ensured the accuracy of the data and revised the manuscript. HH: Designed the study and revised the manuscript. RD: Designed the study and revised the manuscript. RB: Ensured the accuracy of the data and the analysis, wrote and revised the manuscript. RV: Ensured the accuracy of the data and analysis and revised the manuscript. LR: Ensured the accuracy of the data and revised the manuscript. NPK: Conceived the study and revised the manuscript.

Funding

No financial support was received for this study.

Compliance with ethical standards

Conflict of interest

One author (NK) is a paid consultant on the PSI surgical technique for Zimmer-Biomet, Europe. The other authors certify that they have no commercial associations (e.g., consultancies, stock ownership, equity interest, patent/licensing arrangements, etc) that might pose a conflict of interest in connection with the submitted manuscript.

Ethical approval

The study was approved by the ethics committee of Zuyderland-Zuyd, Number 10-T-21.

Informed consent

For this type of study formal informed consent was obtained from each included patient.

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Copyright information

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

Authors and Affiliations

  1. 1.Department of Orthopaedic Surgery and TraumatologyZuyderland Medical CenterSittard-GeleenThe Netherlands
  2. 2.Department of Orthopedic Surgery and TraumatologySt. Anna HospitalGeldropThe Netherlands
  3. 3.Department of RadiologyZuyderland Medical CenterSittard-GeleenThe Netherlands
  4. 4.Department of Methodology and StatisticsMaastricht University Medical CenterMaastrichtThe Netherlands
  5. 5.Department of Orthopedic Surgery And TraumatologyMaastricht University Medical CenterMaastrichtThe Netherlands
  6. 6.RoosterenThe Netherlands

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