Osteoid Osteoma

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Focused Ultrasound Therapy

The FDA has approved Profound Medical’s Sonalleve device for the treatment of patients with Osteoid Osteoma. For more information on treatment site locations, please see Profound Medical’s website.

Focused ultrasound is a noninvasive, therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with osteoid osteoma. This novel technology focuses beams of ultrasound energy precisely and accurately on targets deep in the body without damaging surrounding normal tissue.

How it Works
Where the beams converge, focused ultrasound produces precise ablation (thermal destruction of tissue) enabling osteoid osteoma to be treated without surgery.

The primary options for treatment of osteoid osteoma include pain medications, but some cases require invasive surgery.

For certain patients, focused ultrasound could provide a noninvasive alternative to surgery with less risk of complications – such as surgical wound healing or infection – at a lower cost. It can reach the desired target without damaging surrounding tissue and is repeatable, if necessary.

Clinical Trials

A study has opened at the University of California in San Francisco (UCSF) and Stanford University, which is comparing MR-guided focused ultrasound treatment for osteoid osteoma to radiofrequency ablation. 

A clinical trial at Children’s National in Washington D.C. is treating patients with painful osteoid osteoma. 

A clinical trial in France is treating patients with bone metastatic lesions or with osteoid osteoma. 

A registry, funded in part by the Foundation, has begun and will enroll more patients at additional sites worldwide. For more information, contact Simal Goman at 416-813-6456.

For a full list of osteoid osteoma clinical trials, please see here.

See here for a list of treatment sites
See here for a list of clinical trials sites
See here for a list of laboratory research sites

Regulatory Approval and Reimbursement

The Profound Medical Sonalleve is FDA approved for treatment of osteoid osteoma in the US. Chongqing Haifu Medical Technology is approved for osteoid osteoma in Europe, Russia and China. The Insightec ExAblate Neuro is approved for treating this condition in Europe.

To date, focused ultrasound is not widely reimbursed by medical insurers for treatment of osteoid osteoma.

Notable Papers

Ciatawi K, Dusak IWS, Wiratnaya IGE. High-intensity focused ultrasound-a needleless management for osteoid osteoma: a systematic review. Musculoskelet Surg. 2023 Dec 27. doi: 10.1007/s12306-023-00801-1. PMID: 38150115 

Hu R, He P, Tian X, Guan H. Efficacy and safety of magnetic resonance-guided focused ultrasound for the treatment of osteoid osteoma: A systematic review and meta-analysis. Eur J Radiol. 2023 Jul 22;166:111006. doi: 10.1016/j.ejrad.2023.111006. PMID: 37523874  

Acanfora C, Grassi E, Giacobbe G, Ferrante M, Granata V, Barile A, Cappabianca S. Post-Procedural Follow-Up of the Interventional Radiology’s Management of Osteoid Osteomas and Osteoblastomas. J Clin Med. 2022 Apr 2;11(7):1987. doi: 10.3390/jcm11071987. 

Parmeggiani A, Martella C, Ceccarelli L, Miceli M, Spinnato P, Facchini G. Osteoid osteoma: which is the best mininvasive treatment option? Eur J Orthop Surg Traumatol. 2021 Apr 11. doi: 10.1007/s00590-021-02946-w. 

Arrigoni F, Spiliopoulos S, de Cataldo C, Reppas L, Palumbo P, Mazioti A, Bruno F, Zugaro L, Papakonstantinou O, Barile A, Kelekis A, Masciocchi C, Filippiadis D. A bicentric propensity score matching study comparing percutaneous computed tomography-guided radiofrequency Ablation to Magnetic Resonance-guided Focused Ultrasounds for the treatment of osteoid osteoma. J Vasc Interv Radiol. 2021 Mar 25:S1051-0443(21)00932-5. doi: 10.1016/j.jvir.2021.03.528. 

Arrigoni F, Bruno F, Gianneramo C, Palumbo P, Zugaro L, Zoccali C, Barile A, Masciocchi C. Evolution of the imaging features of osteoid osteoma treated with RFA or MRgFUS during a long-term follow-up: a pictorial review with clinical correlations. Radiol Med. 2020 Feb 10. doi: 10.1007/s11547-020-01134-w. 

Arrigoni F, Napoli A, Bazzocchi A, Zugaro L, Scipione R, Bruno F, Palumbo P, Anzidei M, Mercatelli D, Gravina GL, Zoccali C, Ghanouni P, Barile A, Catalano C, Masciocchi C. Magnetic-resonance-guided focused ultrasound treatment of non-spinal osteoid osteoma in children: multicentre experience. Pediatr Radiol. 2019 May 25. doi: 10.1007/s00247-019-04426-0. [Epub ahead of print] PMID: 31129699 

Scipione R, Anzidei M, Bazzocchi A, Gagliardo C, Catalano C, Napoli A. HIFU for Bone Metastases and other Musculoskeletal Applications. Semin Intervent Radiol. 2018 Oct;35(4):261-267. doi: 10.1055/s-0038-1673363. Epub 2018 Nov 5. 

Bing F, Vappou J, de Mathelin M, Gangi A. Targetability of osteoid osteomas and bone metastases by MR-guided high intensity focused ultrasound (MRgHIFU). Int J Hyperthermia. 2018 Sep 13:1-9. doi: 10.1080/02656736.2018.1508758. 

Yarmolenko PS, Eranki A, Partanen A, Celik H, Kim A, Oetgen M, Beskin V, Santos D, Patel J, Kim PCW, Sharma K. Technical aspects of osteoid osteoma ablation in children using MR-guided high intensityfocussed ultrasound. Int J Hyperthermia. 2018 Feb;34(1):49-58. doi: 10.1080/02656736.2017.1315458. Epub 2017 Apr 24. 
Hudson TJ, Looi T, Pichardo S, Amaral J, Temple M, Drake JM, Waspe AC. Simulating thermal effects of MR-guided focused ultrasound in cortical bone and its surrounding tissue. Med Phys. 2018 Feb;45(2):506-519. doi: 10.1002/mp.12704. Epub 2017 Dec 25. 
Napoli A, Bazzocchi A, Scipione R, Anzidei M, Saba L, Ghanouni P, Cozzi DA, Catalano C. Noninvasive Therapy for Osteoid Osteoma: A Prospective Developmental Study with MR Imaging-guided High-Intensity Focused Ultrasound. Radiology. 2017 Oct;285(1):186-196. doi: 10.1148/radiol.2017162680. Epub 2017 Jun 7. 

Sharma KV, Yarmolenko PS, Celik H, Eranki A, Partanen A, Smitthimedhin A, Kim A, Oetgen M, Santos D, Patel J, Kim P. Comparison of Noninvasive High-Intensity Focused Ultrasound with Radiofrequency Ablation of Osteoid Osteoma. J Pediatr. 2017 Aug 11. pii: S0022-3476(17)30896-X. doi: 10.1016/j.jpeds.2017.06.046. 

Arrigoni F, Barile A, Zugaro L, Splendiani A, Di Cesare E, Caranci F, Ierardi AM, Floridi C, Angileri AS, Reginelli A, Brunese L, Masciocchi C. Intra-articular benign bone lesions treated with Magnetic Resonance-guided Focused Ultrasound (MRgFUS): imaging follow-up and clinical results. Med Oncol. 2017 Apr;34(4):55. doi: 10.1007/s12032-017-0904-7. Epub 2017 Feb 27. 

Rovella MS, Martins GL, Cavalcanti CF, Bor-Seng-Shu E, Camargo OP, Cerri GG, Menezes MR. Magnetic Resonance-Guided High-Intensity Focused Ultrasound Ablation of Osteoid Osteoma: A Case Series Report. Ultrasound Med Biol. 2016 Apr;42(4):919-23. doi: 10.1016/j.ultrasmedbio.2015.11.003. Epub 2016 Jan 16. 
Masciocchi C, Zugaro L, Arrigoni F, Gravina GL, Mariani S, La Marra A, Zoccali C, Flamini S, Barile A. Radiofrequency ablation versus magnetic resonance guided focused ultrasound surgery for minimally invasive treatment of osteoid osteoma: a propensity score matching study. Eur Radiol. 2015 Nov 26. 
Click here for additional references from PubMed. 

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