D16.9
Conditions
Interventions
Group 1: Treatment of a symptom-causing finding (osteoid osteoma) using highly focused ultrasound waves under MRI thermometry.
The HIFU measure is carried out on an inpatient basis
Post-interventional care (usually around 24 hours) takes place on the own ward. MR-HIFU is an innovative technology for precise, focal and non-invasive thermal ablation, made possible by the integrati
Sponsors
Klinikum der Universität München, Campus Großhadern
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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 HIFU
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absence of pain without pain treatment or pain medication, measured on day 28 post intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| Refraining from invasive surgery: Patients with planned treatment for an osteoid osteoma are included in alternative therapy with MR-HIFU; this is to bypass the operation or RFA | — |
Countries
Germany
Contacts
Public ContactChristel Besseler
Klinik und Poliklinik für Radiologie Klinikum der Universität München Campus Großhadern
Outcome results
None listed