CMF Bone Stimulation

Prospective, Randomized, Double-­Blinded, Controlled Multi-­ Center Clinical Trial Evaluating the Use of Non-­Invasive CMF Bone Stimulation as Adjunct to Surgical Treatment of Ankle Fractures

November 22, 2017

  • Clinical Trial Information

    Trial Contact: Harriott, Paula

    Trial Phone: 321.841.3867

  • IRB No: 16.128.10

    Protocol Abbrev: DJO Bone Stim

    Principal Investigator: Kenneth J Koval, MD

    Sub Investigators: Kupiszewski, Stanley MD; Langford, Joshua MD

    Phase: Device: Category N/A

    Age Group: Adult

    Secondary Protocol No: PS-607

    Treatment: CMF OL 1000 Bone Growth Stimulator

    Applicable Disease Sites: Closed unstable ankle fracture

    Therapies Involved: Surgery

  • Objective

    To evaluate the safety and effectiveness of combined magnetic field (CMF) bone growth stimulation as an adjunct to surgical treatment for closed, unstable ankle fractures in
    an adult population.

  • Key Eligibility

    Subject is diagnosed with an unstable, closed, isolated fracture
    of the ankle and underwent operative stabilization with plate(s)
    and/or screws.