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Prospective randomized comparison of early versus newer-generation vertebral access devices for kyphoplasty

Archives of Orthopaedic and Trauma Surgery volume 139, pages 1571–1577 (2019)Cite this article

Abstract

Introduction

Kyphoplasty is an established method of treating osteoporotic vertebral body compression fractures. In recent years, several techniques to enhance the efficiency and outcomes of this surgery have been developed and implemented in clinical practice. In the present study, we assess the impact of two new access instruments on overall operation time and the administered dose area product in comparison with the standard access instrument used in our clinical practice. The two newer comparator devices have been designed with the intention of streamlining intraoperative workflow by omitting several procedural steps.

Materials and methods

This was a single-center prospective randomized trial investigating three distinct access instruments compatible with the Joline Allevo balloon catheter system. Specifically, two newer access devices marketed as being able to enhance surgical workflow (Joline RapidIntro Vertebra Access Device with a trocar tip and Joline SpeedTrack Vertebra Introducer Device with a short, tapered tip) were compared with the older, established Joline Vertebra Access Device from the same firm. Consecutive eligible and consenting patients scheduled to undergo kyphoplasty for osteoporotic vertebral compression fracture refractory to conservative, medical treatment during the period May 2012–August 2015 were randomized to receive surgery using one of the three devices. Besides the use of the trial instruments, all other preoperative, intraoperative and postoperative care was delivered according to standard practice.

Results

91 kyphoplasties were performed on 65 unique patients during the study period. The median operation time across the three groups was 29 min (IQR 22.5–35.5) with a median irradiation time of 2.3 min (IQR 1.2–3.4). The median patient age was 74 years (IQR 66–80). The groups did not significantly differ in terms of age (p = 0.878), sex (p = 0.37), T score (p = 0.718), BMI (p = 0.285) or the applied volume of cement (p = 0.792). There was no significant difference between the treatment groups with respect to surgical duration (p = 0.157) or dose area product (p = 0.913).

Conclusions

Although use of the two newer-generation access instruments were designed to involve fewer unique steps per operation, their use was not associated with reduction in surgical duration, irradiation time or dose area product administered compared with the older, established vertebral access device. Care should be taken to evaluate the impact of new instruments on key surgery-related parameters such as surgical duration and radiation exposure and claims made about new instruments should be assessed a structured fashion.

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Funding

Material support for this study was provided by Joline GmbH & Co KG (Hechingen, Germany). Joline had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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Authors and Affiliations

  1. Department of Neurosurgery, Jena University Hospital-Friedrich Schiller University Jena, Am Klinikum 1, 07747, Jena, Germany

    Falko Schwarz, Aaron Lawson McLean, Anna Luisa Steinberg, Rolf Kalff & Albrecht Waschke

  2. Department of Neurosurgery, Brandenburg Municipal Hospital, Brandenburg, Germany

    Christian Ewald

Authors
  1. Falko Schwarz
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  2. Aaron Lawson McLean
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  3. Anna Luisa Steinberg
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  4. Christian Ewald
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  6. Albrecht Waschke
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Contributions

(1) The conception and design of the study, or acquisition of data, or analysis and interpretation of data: FS; CE; ALS; ALM; (2) drafting the article or revising it critically for important intellectual content: FS; ALM; AW; (3) final approval of the version to be submitted: AW; CE; RK.

Corresponding author

Correspondence to Falko Schwarz.

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Conflict of interest

None of the authors received any compensation for their work on this article, nor have they received compensation from Joline for work undertaken in any other capacity. There are no other relevant financial or non-financial conflicts of interest to declare.

Ethical approval

This study was approved by the institutional review board of Jena University Hospital (reference number: 3287-11/11) and conformed to the Declaration of Helsinki in its present form.

Informed consent

Informed consent to surgery and trial involvement was provided by each and every participant.

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Schwarz, F., Lawson McLean, A., Steinberg, A.L. et al. Prospective randomized comparison of early versus newer-generation vertebral access devices for kyphoplasty. Arch Orthop Trauma Surg 139, 1571–1577 (2019). https://doi.org/10.1007/s00402-019-03235-2

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  • DOI: https://doi.org/10.1007/s00402-019-03235-2

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