Comparative Effectiveness of MRgFUS Versus CTgRFA for Osteoid Osteomas

Conditions

• Osteoid Osteoma

Eligibility Criteria

Sex

ALL

Age

8 Years - N/A

Healthy Volunteers

Accepted

Interventions

• MRgFUS — DEVICE
  Magnetic resonance-guided focused ultrasound ablation of osteoid osteoma
• CTgRFA — DEVICE
  Computed tomography-guided radiofrequency ablation of osteoid osteoma

Study Details

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. The data from the current study would provide clinicians important information in deciding between treatment options for ablation of osteoid osteomas.

Key Dates

Start date

Mar 28, 2017

Status verified

Feb 2025

Primary completion

Jun 30, 2025

Completion

Jun 30, 2025

Study Design

Enrollment

56 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: MRgFUS
  Magnetic resonance-guided focused ultrasound ablation
• Active Comparator: CTgRFA
  Computed tomography-guided radiofrequency ablation

Primary Outcome Measure

Rate of resolution of pain (worst visual analog scale score over last 24 hours < 2.0) [ Time Frame: 1 month ]

Central Contacts

• Maya Aslam
  [email protected]

Locations (3)

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