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No improvement in reducing outliers in coronal axis alignment with patient-specific instrumentation

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

Abstract

Purpose and hypothesis

Patient-specific instrumentation (PSI) uses 3D preoperative imaging to produce individualized cutting blocks specific to patients’ anatomy and according to the preoperative plan with the aim to reduce the number of mechanical leg alignment (MLA) outliers, to improve implant positioning and to decrease surgery time. The primary purpose of this study was to investigate the efficacy of a specific PSI in comparison with standard instrumentation (SI) in reducing the number of MLA outliers. It was hypothesized that the number of MLA outliers would be significantly lower in the PSI group.

Methods

A multicenter randomized controlled trial was implemented. There were 59 patients in the PSI group and 66 in the SI group. The absolute number of outliers outside the ± 3° target neutral MLA was compared between the groups with a Chi-square test. As secondary outcomes, the Knee Society Score (KSS) and the Knee Injury and Osteoarthritis Outcome Score (KOOS) were compared between the groups preoperatively and at 90-day follow-up.

Results

There were 15 (26.3%) MLA outliers in the PSI group and 8 (12.3%) in the SI group. The number of outliers was not independent from the group ( X 2(1) = 3.8, p = 0.04; Relative risk = 1.5). Preoperatively, there were no significant differences between the groups when comparing their KSS and KOOS sub-scores. At 90 days postoperatively, the patients in the SI group showed better KOOS-Quality of Life (KOSS-QOL) in comparison with the PSI group (p < 0.0001).

Conclusion

The use of PSI did not significantly reduce the number of MLA outliers in comparison with SI. There were no differences when comparing the achieved mean MLA of both groups.

Level of evidence

Level I, prospective randomized controlled trial.

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Acknowledgements

The authors would like to thank Mr. Norbert Pfeiff and Mr. Victor Breul (BBraun Aesculap, Tuttlingen, Germany) for their support during all stages of this work.

Authors' contributions

DS, UM, TP, MH, DV and HH recruited the patients and performed all surgeries in their center. CJM assessed all patients pre-and postoperatively in one center and wrote the first draft of the manuscript. FL, DS, TP and UM reviewed the manuscript for its scientific content. TP and DL were in charge of the study concept and design. TP obtained the approval of the local ethics committee.

Author information

Authors and Affiliations

  1. University Hospital of Orthopedic Surgery, Pius-Hospital, Carl von Ossietzky University, Georgstrasse 12, 26121, Oldenburg, Germany

    Uwe Maus & Djordje Lazovic

  2. Research Center of the Department of Orthopedics and Joint Replacement, Schoen Klinik Hamburg Eilbek, Dehnhaide 120, 22081, Hamburg, Germany

    Carlos J. Marques

  3. Department of Orthopedics and Joint Replacement, Schoen Klinik Hamburg Eilbek, Dehnhaide 120, 22081, Hamburg, Germany

    David Scheunemann & Frank Lampe

  4. Krankenhaus Märkisch Oderland, Orthopedic Clinic, Lehrkrankenhaus der Medizinischen Hochschule Brandenburg, Sonnenburger Weg 3, 16269, Wriezen, Germany

    Hagen Hommel

  5. Klinik für Orthopädie und Unfallchirurgie, St. Remigius Krankenhaus Opladen, An St. Remigius 26, 51379, Leverkusen, Germany

    Dennis Vogel

  6. Klinik für allgemeine Orthopädie, Endoprothetik und Kinderorthopädie, Katholisches Klinikum Koblenz-Montabaur, Kardinal-Krementz-Str. 1-5, 56073, Koblenz-Montabaur, Germany

    Martin Haunschild

  7. Orthopedic Department, Center for Musculoskeletal Surgery, Charité-Universitätsmedizin Berlin, Charitéplatz, 10117, Berlin, Germany

    Tilman Pfitzner

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  1. Uwe Maus
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Corresponding author

Correspondence to Carlos J. Marques.

Ethics declarations

Conflict of interest

The institution of one author (CJM) receives funding from BBraun Aesculap to support his research position at the Research Center of the Department of Orthopedics and Joint Replacement. FL, DS, and DL are consultant surgeons for BBraun Aesculap. TP is consultant surgeon for DepuySynthes. UM, MH, DV and HH have no conflict of interests to declare in relation to this manuscript.

Funding

This study was sponsored by Aesculap AG, Am Aesculap-Platz, D-78532 Tuttlingen, Germany. The costs related with the MRI scans and the manufacture of the PSI instruments were covered by the sponsor.

Ethical statement

The Medical Ethics Commission of the Charité-Universitätsmedizin Berlin approved the research proposal (#EA1/339/13).

Informed consent

Before participating, all patients were required to read and sign an informed consent form.

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Maus, U., Marques, C.J., Scheunemann, D. et al. No improvement in reducing outliers in coronal axis alignment with patient-specific instrumentation. Knee Surg Sports Traumatol Arthrosc 26, 2788–2796 (2018). https://doi.org/10.1007/s00167-017-4741-1

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  • DOI: https://doi.org/10.1007/s00167-017-4741-1

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