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Is TKA Using Patient-specific Instruments Comparable to Conventional TKA? A Randomized Controlled Study of One System

  • Clinical Research
  • Published:
Clinical Orthopaedics and Related Research®

A CORR Insights® to this article was published on 18 September 2013

Abstract

Background

Patient-specific CT-based instrumentation may reduce implant malpositioning and improve alignment in TKA. However, it is not known whether this innovation is an advance that benefits patients.

Questions/purposes

We evaluated (1) the precision of patient-specific TKA by comparing the incidence of outliers in postoperative alignment between TKAs using patient-specific instruments and TKAs using conventional instruments, and (2) the reliability of patient-specific instruments by intraoperatively investigating whether the surgery could be completed with patient-specific instruments alone.

Methods

In this randomized controlled trial, we compared patient-specific TKA instruments from one manufacturer (n = 50) with conventional TKA instruments (n = 50). Postoperative hip-knee-ankle angles, femoral component rotation, and coronal and sagittal alignments of each component were measured. The validity of the patient-specific instrument was examined using cross-checking procedures with conventional instruments during the surgeries. When the procedure could not be completed accurately with patient-specific instruments, the procedure was converted to TKA using conventional instruments, and the frequency of this occurrence was tallied.

Results

Outliers in the hip-knee-ankle angle were comparable between groups (12% in the patient-specific instrument group and 10% in the conventional instrument group). Other parameters such as sagittal alignment and femoral component rotation did not differ in terms of outliers. Patient-specific guides were abandoned in eight knees (16%) during the surgery because of malrotation of the femoral components and decreased slope of the tibia.

Conclusions

Accuracy was comparable between TKAs done with patient-specific instruments and those done with conventional instruments. However, the patient-specific instrument procedures had to be aborted frequently, incurring expenses that did not benefit patients.

Level of Evidence

Level II, therapeutic study. See Instructions for Authors for a complete description of levels of evidence.

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Acknowledgments

We thank Sang Min Lee MD for help with acquisition of a certificate of approval from the institutional review board.

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Authors and Affiliations

  1. Joint Reconstruction Center, Seoul NOW Hospital, Kyungki-Do, Korea

    Yoon Whan Roh MD

  2. Department of Orthopedic Surgery, Seoul National University Hospital, 101 Daehak-Ro, Jongno-Gu, Seoul, 110-744, Korea

    Tae Woo Kim MD, Sahnghoon Lee MD, PhD, Sang Cheol Seong MD, PhD & Myung Chul Lee MD, PhD

Authors
  1. Yoon Whan Roh MD
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  2. Tae Woo Kim MD
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  3. Sahnghoon Lee MD, PhD
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  4. Sang Cheol Seong MD, PhD
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  5. Myung Chul Lee MD, PhD
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Corresponding author

Correspondence to Myung Chul Lee MD, PhD.

Additional information

Each author certifies that he, or a member of his immediate family, has no commercial associations (eg, consultancies, stock ownership, equity interest, patent/licensing arrangements, etc) that might pose a conflict of interest in connection with the submitted article.

All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research editors and board members are on file with the publication and can be viewed on request.

Clinical Orthopaedics and Related Research neither advocates nor endorses the use of any treatment, drug, or device. Readers are encouraged to always seek additional information, including FDA approval status, of any drug or device before clinical use.

Each author certifies that his or her institution approved the human protocol for this investigation, that all investigations were conducted in conformity with ethical principles of research, and that informed consent for participation in the study was obtained.

This study was performed at Seoul National University Hospital, Seoul, Korea.

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Roh, Y.W., Kim, T.W., Lee, S. et al. Is TKA Using Patient-specific Instruments Comparable to Conventional TKA? A Randomized Controlled Study of One System. Clin Orthop Relat Res 471, 3988–3995 (2013). https://doi.org/10.1007/s11999-013-3206-1

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  • DOI: https://doi.org/10.1007/s11999-013-3206-1

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