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Phase I/II Multi-Institutional Study of Percutaneous Radiofrequency Ablation for Painful Osteoid Osteoma (JIVROSG-0704)

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Abstract

Purpose

This multicenter prospective study was conducted to evaluate the safety and efficacy of percutaneous radiofrequency ablation (RFA) for painful osteoid osteoma (OO).

Materials and Methods

Patients with OO (femur: n = 17, tibia: n = 2, humerus: n = 1, rib: n = 1) were enrolled and treated with RFA. In phase I, nine patients were evaluated for safety. In phase II, 12 patients were accrued, and an intent-to-treat analysis was performed on all patients. The primary endpoint was to evaluate the treatment safety. The secondary endpoint was to evaluate the efficacy for pain relief by the visual analogue scale (VAS) at 4 weeks after RFA. Treatment efficacy was classified as significantly effective (SE) when VAS score decreased by ≥5 or score was <2, moderately effective when VAS score decreased by <5–≥2 and score was ≥2, and not effective (NE) when VAS score decreased by <2 or score was increased. Cases where the need for analgesics increased after treatment were also NE.

Results

RFA procedures were completed in all patients. Minor adverse effects (AEs) were observed as 4.8–14.3 % in 12 patients, and no major AEs were observed. Mean VAS score was 7.1 before treatment, 1.6 at 1 week, 0.3 at 4 weeks, and 0.2 at 3 months. All procedures were classified as SE. Pain recurrence was not noted in any patient during follow-up (mean: 15.1 months).

Conclusion

RFA is a safe, highly effective, and fast-acting treatment for painful extraspinal OO. Future studies with a greater number of patients are needed.

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Funding

This study was funded by a Health and Labour Sciences Research Grant (Number 01901625) from the Ministry of Health, Labour and Welfare of Japan.

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Authors and Affiliations

  1. Department of Interventional Radiology and Clinical Ultrasound Center, Gunma University Hospital, 3-39-15, Showa-machi, Maebashi, Gunma, 371-8511, Japan

    Masaya Miyazaki, Yoshito Tsushima & Keigo Endo

  2. Division of Diagnostic Radiology, National Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan

    Yasuaki Arai & Miyuki Sone

  3. Medical Center for Translational Research, Osaka University Hospital, 2-15 Yamadaoka, Suita, Osaka, 565-0871, Japan

    Akira Myoui

  4. Department of Radiology, Okayama University Medical School, 2-5-1 Shikatacho, Kita-ku, Okayama, 700-8558, Japan

    Hideo Gobara & Susumu Kanazawa

  5. Department of Radiology, Massachusetts General Hospital, Harvard Medical School, 55 Fruit Street, Boston, MA, 02114, USA

    Daniel I. Rosenthal

  6. Department of Radiology, Iwate Medical University School of Medicine, 19-1 Uchimaru, Morioka, 020-8505, Japan

    Shigeru Ehara

Authors
  1. Masaya Miyazaki
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  2. Yasuaki Arai
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  3. Akira Myoui
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  4. Hideo Gobara
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  5. Miyuki Sone
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  6. Daniel I. Rosenthal
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  7. Yoshito Tsushima
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  8. Susumu Kanazawa
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  9. Shigeru Ehara
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  10. Keigo Endo
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Corresponding author

Correspondence to Masaya Miyazaki.

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The authors declare that they have no conflict of interest.

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Miyazaki, M., Arai, Y., Myoui, A. et al. Phase I/II Multi-Institutional Study of Percutaneous Radiofrequency Ablation for Painful Osteoid Osteoma (JIVROSG-0704). Cardiovasc Intervent Radiol 39, 1464–1470 (2016). https://doi.org/10.1007/s00270-016-1438-7

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  • DOI: https://doi.org/10.1007/s00270-016-1438-7

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