Clinical Trial: Comparative Effectiveness of MRgFUS Versus CTgRFA for Osteoid Osteomas

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Phase III Study to Compare the Effectiveness of Magnetic Resonance Guided Focused Ultrasound With Computed Tomography Guided Radiofrequency Ablation for Treatment of Osteoid Oste

Brief Summary: 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.

Detailed Summary:
Sponsor: Matthew Bucknor

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Procedure time [ Time Frame: Treatment day ]
    On the day of the treatment, the procedure time will be recorded
  • Patient preference [ Time Frame: 2 weeks ]
    2 weeks after treatment, patient preference surveys will be assessed
  • Patient quality of life [ Time Frame: 1 month ]
    1 month after treatment, patient quality of life surveys will be assessed
  • Medication use [ Time Frame: 5 days before, five days after, 1 month after ]
    Self reported medication use for 5 days before, five days after, and 1 month after the treatment
  • Adverse events [ Time Frame: 1 month ]
    All adverse events occurring within the first month will be recorded at 1 month following the procedure
  • Worst VAS [ Time Frame: First 5 days, 1 week, 2 weeks, 3 weeks, 1 month, 6 months, 12 months ]
    Worst VAS over the last 24 hours will be assessed for each of the first 5 days following the treatment and then at 1 week, 2 weeks, 3 weeks, 1 month, 6 months, and 12 months following the treatment


Original Secondary Outcome: Same as current

Information By: University of California, San Francisco

Dates:
Date Received: September 30, 2016
Date Started: November 2016
Date Completion:
Last Updated: October 3, 2016
Last Verified: October 2016