Masaya Miyazaki1, Yasuaki Arai2, Akira Myoui3, Hideo Gobara4, Miyuki Sone2, Daniel I Rosenthal5, Yoshito Tsushima6, Susumu Kanazawa4, Shigeru Ehara7, Keigo Endo6. 1. Department of Interventional Radiology and Clinical Ultrasound Center, Gunma University Hospital, 3-39-15, Showa-machi, Maebashi, Gunma, 371-8511, Japan. mmiyazak@gunma-u.ac.jp. 2. Division of Diagnostic Radiology, National Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. 3. Medical Center for Translational Research, Osaka University Hospital, 2-15 Yamadaoka, Suita, Osaka, 565-0871, Japan. 4. Department of Radiology, Okayama University Medical School, 2-5-1 Shikatacho, Kita-ku, Okayama, 700-8558, Japan. 5. Department of Radiology, Massachusetts General Hospital, Harvard Medical School, 55 Fruit Street, Boston, MA, 02114, USA. 6. Department of Interventional Radiology and Clinical Ultrasound Center, Gunma University Hospital, 3-39-15, Showa-machi, Maebashi, Gunma, 371-8511, Japan. 7. Department of Radiology, Iwate Medical University School of Medicine, 19-1 Uchimaru, Morioka, 020-8505, Japan.
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.
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.
Authors: Arian Mansur; Tushar Garg; Apurva Shrigiriwar; Vahid Etezadi; Christos Georgiades; Peiman Habibollahi; Timothy C Huber; Juan C Camacho; Sherif G Nour; Alan Alper Sag; John David Prologo; Nariman Nezami Journal: Diagnostics (Basel) Date: 2022-05-24