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

Autor: Keigo Endo, Susumu Kanazawa, Shigeru Ehara, Daniel I. Rosenthal, Hideo Gobara, Masaya Miyazaki, Yasuaki Arai, Yoshito Tsushima, Miyuki Sone, Akira Myoui
Rok vydání: 2016
Předmět:
Zdroj: CardioVascular and Interventional Radiology. 39:1464-1470
ISSN: 1432-086X
0174-1551
DOI: 10.1007/s00270-016-1438-7
Popis: This multicenter prospective study was conducted to evaluate the safety and efficacy of percutaneous radiofrequency ablation (RFA) for painful osteoid osteoma (OO).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.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).RFA is a safe, highly effective, and fast-acting treatment for painful extraspinal OO. Future studies with a greater number of patients are needed.
Databáze: OpenAIRE
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