MedPath

AVOID Evaluation of the ablation of osteoid osteomas using MR-guided high-intensity ultrasound with regard to therapeutic efficacy

Not Applicable
Recruiting
Conditions
D16.9
Bone 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
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

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
NameTimeMethod
Absence of pain without pain treatment or pain medication, measured on day 28 post intervention.
Secondary Outcome Measures
NameTimeMethod
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
© Copyright 2025. All Rights Reserved by MedPath