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.
| Original language | English |
|---|---|
| Pages (from-to) | 1464-1470 |
| Number of pages | 7 |
| Journal | CardioVascular and Interventional Radiology |
| Volume | 39 |
| Issue number | 10 |
| DOIs | |
| Publication status | Published - Oct 1 2016 |
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Keywords
- Clinical trial
- Osteoid osteoma
- Radiofrequency ablation
ASJC Scopus subject areas
- Medicine(all)
- Radiology Nuclear Medicine and imaging
- Cardiology and Cardiovascular Medicine
Cite this
Phase I/II Multi-Institutional Study of Percutaneous Radiofrequency Ablation for Painful Osteoid Osteoma (JIVROSG-0704). / Miyazaki, Masaya; Arai, Yasuaki; Myoui, Akira; Gobara, Hideo; Sone, Miyuki; Rosenthal, Daniel I.; Tsushima, Yoshito; Kanazawa, Susumu; Ehara, Shigeru; Endo, Keigo.
In: CardioVascular and Interventional Radiology, Vol. 39, No. 10, 01.10.2016, p. 1464-1470.Research output: Contribution to journal › Article
}
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
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
UR - http://www.scopus.com/inward/record.url?scp=84982878872&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84982878872&partnerID=8YFLogxK
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 and Interventional Radiology
JF - CardioVascular and Interventional Radiology
SN - 7415-5101
IS - 10
ER -