AVOID Evaluation of the ablation of osteoid osteomas using MR-guided high-intensity ultrasound with regard to therapeutic efficacy
- Conditions
- D16.9Bone and articular cartilage, unspecified
- Registration Number
- DRKS00015448
- Lead Sponsor
- Klinikum der Universität München, Campus Großhadern
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
All patients with clinical suspicion of osteoid osteoma based on the presence of typical symptoms such as localized nocturnal pain with NSAID relief and unrelated to trauma or activity.
Typical imaging findings on CT, MRI, x-rays and bone scintigraphy.
Patients with previous unsuccessful surgical resection or RFA.
Systemic diseases that, in the investigator's opinion, limit the patient's ability to tolerate the general anesthesia required for the procedure (e.g. severe infections, Liver, kidney or other organ dysfunction)
Implant, prosthesis or scar tissue in the HIFU area
Target lesion <1 cm away from nerves, spinal canal, bladder or intestine
Target lesion <1 cm from the epiphyseal plate
Target lesion in the skull or vertebral body
Contraindication to MRI
Inability to freely tolerate the position during HIF
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Absence of pain without pain treatment or pain medication, measured on day 28 post intervention.
- Secondary Outcome Measures
Name Time Method Refraining from invasive surgery:<br>Patients with planned treatment for an osteoid osteoma are included in alternative therapy with MR-HIFU; this is to bypass the operation or RFA