TY - JOUR
T1 - Phase I/II Multi-Institutional Study of Percutaneous Radiofrequency Ablation for Painful Osteoid Osteoma (JIVROSG-0704)
AU - Miyazaki, Masaya
AU - Arai, Yasuaki
AU - Myoui, Akira
AU - Gobara, Hideo
AU - Sone, Miyuki
AU - Rosenthal, Daniel I.
AU - Tsushima, Yoshito
AU - Kanazawa, Susumu
AU - Ehara, Shigeru
AU - Endo, Keigo
N1 - Funding Information:
This study was funded by a Health and Labour Sciences Research Grant (Number 01901625) from the Ministry of Health, Labour and Welfare of Japan.
Publisher Copyright:
© 2016, Springer Science+Business Media New York and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE).
PY - 2016/10/1
Y1 - 2016/10/1
N2 - 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.
AB - 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.
KW - Clinical trial
KW - Osteoid osteoma
KW - Radiofrequency ablation
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U2 - 10.1007/s00270-016-1438-7
DO - 10.1007/s00270-016-1438-7
M3 - Article
C2 - 27491406
AN - SCOPUS:84982878872
VL - 39
SP - 1464
EP - 1470
JO - Cardiovascular Radiology
JF - Cardiovascular Radiology
SN - 7415-5101
IS - 10
ER -