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Synovial fluid detection in intra-articular injections using a bioimpedance probe (BIP) needle—a clinical study

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Abstract

Intra-articular glucocorticoid injections are the recommended treatment for active arthritis, but accurate positioning of the needle may be challenging. Inexperienced physicians might decide not to inject because an unsuccessful injection impairs clinical outcome and may lead to complications; however, choosing not to inject may impair or delay the best possible treatment. Here, we address this problem by introducing a novel Bioimpedance Probe (BIP) Needle-guidance method that was tested in a clinical study. The BIP Needle was utilized for detection of synovial fluid. It measures real-time bioimpedance spectra and identifies when the needle tip is in contact with the synovial fluid. Injections into 80 joints with active arthritis were performed by an experienced rheumatologist using the BIP Needle. The location of the BIP Needle was ensured by aspiration of synovial fluid, absence of resistance during injection, and/or using real-time ultrasound imaging. Sensitivity and specificity of the device for synovial fluid detection were 86 % (CI 75–93 %) and 85 % (CI 74–92 %), respectively. The BIP Needles showed high spatial resolution and differentiated the synovial fluid from the surrounding tissues. However, lack of synovial fluid, anatomic variability, and intra-articular structures challenged the technology. The BIP Needles provided adequate results in intra-articular injections. Performance of the device was good even in small joints, which may be the most difficult for inexperienced physicians. Further performance improvement can be expected when more data is collected for mathematical models. Overall, this novel method showed potential to be used in real-time needle guidance.

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Acknowledgments

Injeq Ltd provided BIP Needles and bioimpedance analyzer for the study. We thank all participating patients and study nurses.

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Authors and Affiliations

  1. R&D Department, Injeq Ltd., Tampere, Finland

    Sanna Halonen, Juho Kari & Kai Kronström

  2. Department of Medicine, Division of Rheumatology, Helsinki University Central Hospital and University of Helsinki, Helsinki, Finland

    Eeva Kankaanpää, Pinja Parmanne, Heikki Relas, Riitta Luosujärvi & Ritva Peltomaa

  3. Helsinki University Central Hospital, Helsinki Triangle Hospital, Haartmaninkatu 4, PO Box 372, FI-00029 HUS, Helsinki, Finland

    Ritva Peltomaa

Authors
  1. Sanna Halonen
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  2. Eeva Kankaanpää
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  3. Juho Kari
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  4. Pinja Parmanne
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  5. Heikki Relas
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  6. Kai Kronström
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  7. Riitta Luosujärvi
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  8. Ritva Peltomaa
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Corresponding author

Correspondence to Ritva Peltomaa.

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Conflict of interests

SH, JK, and KK are employees of Injeq Ltd; KK is a stakeholder of Injeq Ltd. Other authors have nothing to declare.

Patient consent

Persons gave their informed consent prior to their inclusion in the study.

Ethics approval

This clinical study has been approved by the Ethics Committee of the Department of Medicine, Helsinki University Central Hospital, Finland, and has therefore been performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments.

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Halonen, S., Kankaanpää, E., Kari, J. et al. Synovial fluid detection in intra-articular injections using a bioimpedance probe (BIP) needle—a clinical study. Clin Rheumatol 36, 1349–1355 (2017). https://doi.org/10.1007/s10067-016-3210-4

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  • DOI: https://doi.org/10.1007/s10067-016-3210-4

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