NCT02923011 · Matthew Bucknor
Comparative Effectiveness of MRgFUS Versus CTgRFA for Osteoid Osteomas
What this study is about
Osteoid osteomas are painful, benign bone tumors that occur most frequently in young males between ages 10 and 20 years.
View original scientific description
Osteoid osteomas are painful, benign bone tumors that occur most frequently in young males between ages 10 and 20 years. The goal of the proposed study is based on the premise that MRgFUS is noninferior to CT-guided radiofrequency ablation (CTgRFA), in terms of pain reduction following treatment of osteoid osteomas, and offers possible improvements with regards to 1) post-procedural pain, 2) clinical resource utilization, 3) patient experience, and/or 4) adverse events.
Interventions
DEVICE
MRgFUS
Magnetic resonance-guided focused ultrasound ablation of osteoid osteoma
DEVICE
CTgRFA
Computed tomography-guided radiofrequency ablation of osteoid osteoma
Primary outcome measures
Rate of resolution of pain (worst visual analog scale score over last 24 hours < 2.0)
Time frame: 1 month
1 month after treatment, worst VAS score over the last 24 hours will be assessed
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Men and women ages ≥ 8 years old. 2. Diagnosis of osteoid osteoma as confirmed when a musculoskeletal radiologist and orthopedic oncologist agree that a patient's imaging and clinical history are most compatible with the diagnosis of osteoid osteoma. A patient referred by a clinician other than orthopedic oncologist will require a clinic visit with an orthopedic oncologist for study inclusion. 3. Patients must have medically uncontrolled pain from an osteoid osteoma, as defined by pain, which, in the view of the referring orthopedic oncologist significantly interferes with that patient's activities of daily living. Pain may be refractory to management with medications because of inadequate pain control, or because of side effects of the pain medication. 4. If patients have an additional site of pain, it must be 2 points less severe and distinguishable from the pain at the osteoid osteoma site. 5. Patients (or guardians/parents) who are able and willing to give c
Where
- Palo Alto, California
- San Francisco, California
- Rochester, Minnesota
Collaborators
Focused Ultrasound Foundation
Related conditions & keywords
Frequently asked questions
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Data: ClinicalTrials.gov · synced Feb 19, 2025 · Source of record for eligibility and locations